UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`Before the Honorable Clark S. Cheney
`Administrative Law Judge
`
`
`In the Matter of
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`CERTAIN PRE-FILLED SYRINGES FOR
`INTRAVITREAL INJECTION AND
`COMPONENTS THEREOF
`
`
`Investigation No. 337-TA-1207
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`RESPONDENT REGENERON’S IDENTIFICATION OF EXPERT WITNESSES
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`Pursuant
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`to
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`the procedural schedule
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`(Order No. 8), Respondent Regeneron
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`Pharmaceuticals, Inc. (“Regeneron” or “Respondent”) submits this identification of expert
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`witnesses that Regeneron currently believes may testify on its behalf in this Investigation, either
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`live, through witness statements, or by deposition, and may submit expert reports and/or rebuttal
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`expert reports, as permitted by the Ground Rules and the Administrative Law Judge.
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`This identification of experts and expected areas of testimony is preliminary and is based
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`on Regeneron’s current understanding of the limited evidence produced by Complainant thus far
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`in discovery. Accordingly, Regeneron reserves the right to supplement this identification at any
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`time, including by identifying additional expert witnesses, designating additional topics on which
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`the below-listed witnesses or any additional expert witness may opine, and/or addressing new
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`issues that may arise in discovery and in Complainant’s expert witness disclosure. Regeneron
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`reserves the right to call any expert witness that a party deposes; call expert witnesses identified
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`by, or called to testify at the hearing by Complainant or Staff; and call impeachment witnesses not
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`identified below.
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`1
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`A. James Agalloco
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`Mr. Agalloco is an expert in the field of sterilization processes of medical devices and drug
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`products. Mr. Agalloco’s expertise in sterilization includes expertise in terminal sterilization of
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`pre-filled syringes, and the methods used to achieve a substantially sterile product suitable for
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`medical use, including vaporized hydrogen peroxide (VHP) and ethylene oxide (EO). Mr.
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`Agalloco’s curriculum vitae is attached as Exhibit A.
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`Mr. Agalloco may provide expert opinions and testimony regarding the technical
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`background and state of the art relevant to the asserted patent, the level of skill of one of ordinary
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`skill in the art of the asserted patent, the interpretation and scope of the asserted patent, the validity
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`and enforceability of the asserted patent, the inventorship of the asserted patent, the disclosure in
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`the specification of the asserted patent, the development and/or operation of Novartis’s1 domestic
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`industry products and Regeneron’s accused product, non-infringement of the asserted claims by
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`Regeneron’s accused products, Novartis’s practice of the domestic industry claims of the asserted
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`patents, objective indicia of nonobviousness, the public interest, and any other related issues
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`pertinent to Regeneron’s defenses and Novartis’s contentions for which expert testimony is
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`required or useful. Mr. Agalloco may also rebut the expert witness report(s), opinions, and
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`testimony of Novartis’s expert witness(es), if any, regarding these matters.
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`
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`B. Dr. David Brown
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`Dr. Brown is a medical doctor and expert in the field of ophthalmology and the treatment
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`of patients having various ocular diseases, including diseases of the retina. Dr. Brown’s expertise
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`1 Novartis refers to Complainants Novartis Pharma AG, Novartis Pharmaceuticals Corporation,
`and Novartis Technology LLC
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`2
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`

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`in ophthalmology includes expertise in the treatment of patients with choroidal neovascularization
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`wet age-related macular degeneration, macular edema secondary to retinal vein occlusion (RVO)
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`including both branch RVO (bRVO) and central RVO (cRVO), choroidal neovascularization
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`secondary to pathologic myopia (PM), diabetic macular edema (DME), diabetic retinopathy, and
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`proliferative retinopathy. Dr. Brown’s curriculum vitae is attached as Exhibit B.
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`Dr. Brown may provide expert opinions and testimony regarding the technical background
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`and state of the art relevant to certain claims of the asserted patent, the level of skill of one of
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`ordinary skill in the art of certain claims of the asserted patent, the interpretation and scope of
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`certain claims of the asserted patent, the validity and enforceability of certain claims of the asserted
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`patent, the operation of Novartis’s domestic industry products and Regeneron’s accused product,
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`non-infringement of the asserted claims by Regeneron’s accused products, Novartis’s practice of
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`the domestic industry claims of the asserted patents, doctors’ viewpoints and preferences regarding
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`pre-filled syringe and vial and syringe dosage forms for the delivery of drugs via intravitreal
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`injection, objective indicia of nonobviousness, the public interest, the harm to patients in the
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`marketplace if EYLEA PFS is no longer sold, the appropriate remedy should a violation be found,
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`and any other related issues pertinent to Regeneron’s defenses and Novartis’s contentions for
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`which expert testimony is required or useful. Dr. Brown may also rebut the expert witness
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`report(s), opinions, and testimony of Novartis’s expert witness(es), if any, regarding these matters.
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`
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`C. Dr. Dennis Carlton
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`Dr. Carlton is an expert in the field of economics. Dr. Carlton’s expertise in economics
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`includes expertise in the economics of drug sales and the marketplace for drug products, as well
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`3
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`as the dynamics of different dosage forms for the same product and their interactions on the
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`marketplace. Dr. Carlton’s curriculum vitae is attached as Exhibit C.
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`Dr. Carlton may provide expert opinions and testimony regarding the alleged existence of
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`Novartis’s domestic industry, the appropriate remedy in this Investigation, the appropriate amount
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`of bond to be posted during the Presidential review period, the state of the relevant marketplace,
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`the public interest, the harm to patients in the marketplace if EYLEA PFS is no longer sold,
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`objective indicia of nonobviousness, and any other related issues pertinent to Regeneron’s defenses
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`and Novartis’s contentions for which expert testimony is required or useful. Dr. Carlton may also
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`rebut the expert witness report(s), opinions, and testimony of Novartis’s expert witness(es), if any,
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`regarding these matters.
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`
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`D. Dr. Patricia D’Amore
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`Dr. D’Amore is an expert in the field of vascular growth and development and vascular
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`endothelial growth factor (VEGF). Dr. D’Amore’s expertise in the field of vascular growth and
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`development and VEGF includes expertise in the structure and function of VEGF, including its
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`role as a therapeutic target, the universe of molecules and compounds which can interact with,
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`interfere with, disrupt, or bind to VEGF (including antibody and non-antibody VEGF antagonists),
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`and the use of those compounds to treat various diseases and disorders relating to VEGF. Dr.
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`D’Amore’s curriculum vitae is attached as Exhibit D.
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`Dr. D’Amore may provide expert opinions and testimony regarding the technical
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`background and state of the art relevant to the asserted patent, the level of skill of one of ordinary
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`skill in the art of the asserted patent, the interpretation and scope of the claims of the asserted
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`patent, the validity of the asserted patent, the disclosure in the specification of the asserted patent,
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`4
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`and any other related issues pertinent to Regeneron’s defenses and Novartis’s contentions for
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`which expert testimony is required or useful. Dr. D’Amore may also rebut the expert witness
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`report(s), opinions, and testimony of Novartis’s expert witness(es), if any, regarding these matters.
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`
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`E. Dr. Seth Kaplan
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`Dr. Kaplan is an expert in the field of economics. Dr. Kaplan’s expertise in economics
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`includes expertise in the economics of drug sales and the marketplace for drug products, as well
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`as the dynamics of different dosage forms for the same product and their interactions on the
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`marketplace. Dr. Kaplan’s curriculum vitae is attached as Exhibit E.
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`Dr. Kaplan may provide expert opinions and testimony regarding the alleged existence of
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`Novartis’s domestic industry, the appropriate remedy in this Investigation, the appropriate amount
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`of bond to be posted during the Presidential review period, the state of the relevant marketplace,
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`the public interest, the harm to patients in the marketplace if EYLEA PFS is no longer sold,
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`objective indicia of nonobviousness, and any other related issues pertinent to Regeneron’s defenses
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`and Novartis’s contentions for which expert testimony is required or useful. Dr. Kaplan may also
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`rebut the expert witness report(s), opinions, and testimony of Novartis’s expert witness(es), if any,
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`regarding these matters.
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`
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`F. Dr. Szilárd Kiss
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`Dr. Kiss is a medical doctor and expert in the field of ophthalmology and the treatment of
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`patients having various ocular diseases, including diseases of the retina. Dr. Kiss’s expertise in
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`ophthalmology includes expertise in the treatment of patients with choroidal neovascularization
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`wet age-related macular degeneration, macular edema secondary to retinal vein occlusion (RVO)
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`5
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`

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`including both branch RVO (bRVO) and central RVO (cRVO), choroidal neovascularization
`
`secondary to pathologic myopia (PM), diabetic macular edema (DME), diabetic retinopathy, and
`
`proliferative retinopathy. Dr. Kiss’s curriculum vitae is attached as Exhibit F.
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`Dr. Kiss may provide expert opinions and testimony regarding the technical background
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`and state of the art relevant to certain claims of the asserted patent, the level of skill of one of
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`ordinary skill in the art of certain claims of the asserted patent, the interpretation and scope of
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`certain claims of the asserted patent, the validity and enforceability of certain claims of the asserted
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`patent, the operation of Novartis’s domestic industry products and Regeneron’s accused product,
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`non-infringement of the asserted claims by Regeneron’s accused products, Novartis’s practice of
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`the domestic industry claims of the asserted patents, doctors’ viewpoints and preferences regarding
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`pre-filled syringe and vial and syringe dosage forms for the delivery of drugs via intravitreal
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`injection, objective indicia of nonobviousness, the public interest, the harm to patients in the
`
`marketplace if EYLEA PFS is no longer sold, the appropriate remedy should a violation be found,
`
`and any other related issues pertinent to Regeneron’s defenses and Novartis’s contentions for
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`which expert testimony is required or useful. Dr. Kiss may also rebut the expert witness report(s),
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`opinions, and testimony of Novartis’s expert witness(es), if any, regarding these matters.
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`G. Horst Koller
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`Mr. Koller is an expert in the field of pre-filled syringes and other similar medical devices
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`and delivery forms, and the development, manufacturing, quality assurances, regulatory
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`requirements, and industry of the same. Mr. Koller’s expertise in pre-filled syringes includes
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`expertise in the selection and optimization of the various components of a pre-filled syringe,
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`including the barrel, stopper, needle and needle connection, and plunger, the siliconization of the
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`6
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`pre-filled syringe including the measurement of the amount of silicone oil deposited, break loose
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`and slide force testing techniques and optimization, sterilization of the pre-filled syringe, both of
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`the components and the final drug product, and the manufacturing techniques and optimization of
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`the entire pre-filled syringe and its components. Mr. Koller’s curriculum vitae is attached as
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`Exhibit G.
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`Mr. Koller may provide expert opinions and testimony regarding the technical background
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`and state of the art relevant to the asserted patent, the level of skill of one of ordinary skill in the
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`art of the asserted patent, the interpretation and scope of the claims of the asserted patent, the
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`validity and enforceability of the asserted patent, the inventorship of the asserted patent, the
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`disclosure in the specification of the asserted patent, the development and/or operation of
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`Novartis’s domestic industry products and Regeneron’s accused product, non-infringement of the
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`asserted claims by Regeneron’s accused products, Novartis’s practice of the domestic industry
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`claims of the asserted patents, objective indicia of nonobviousness, the public interest, and any
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`other related issues pertinent to Regeneron’s defenses and Novartis’s contentions for which expert
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`testimony is required or useful. Mr. Koller may also rebut the expert witness report(s), opinions,
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`and testimony of Novartis’s expert witness(es), if any, regarding these matters.
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`
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`H. W. Gregory Sawyer, Ph.D.
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`Dr. Sawyer is an expert in the field of tribology, which is the study of interacting surfaces
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`in relative motion. Dr. Sawyer’s expertise in tribology includes expertise in the selection and
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`optimization of the various components of a pre-filled syringe, including the barrel, stopper, needle
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`and needle connection, and plunger, the siliconization of the pre-filled syringe including the
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`7
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`measurement of the amount of silicone oil deposited, and break loose and slide force testing
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`techniques and optimization. Dr. Sawyer’s curriculum vitae is attached as Exhibit H.
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`Dr. Sawyer may provide expert opinions and testimony regarding the technical background
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`and state of the art relevant to the asserted patent, the level of skill of one of ordinary skill in the
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`art of the asserted patent, the interpretation and scope of the claims of the asserted patent, the
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`validity and enforceability of the asserted patent, the inventorship of the asserted patent, the
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`disclosure in the specification of the asserted patent, the development and/or operation of
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`Novartis’s domestic industry products and Regeneron’s accused product, non-infringement of the
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`asserted claims by Regeneron’s accused products, Novartis’s practice of the domestic industry
`
`claims of the asserted patents, objective indicia of nonobviousness, the public interest, and any
`
`other related issues pertinent to Regeneron’s defenses and Novartis’s contentions for which expert
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`testimony is required or useful. Dr. Sawyer may also rebut the expert witness report(s), opinions,
`
`and testimony of Novartis’s expert witness(es), if any, regarding these matters.
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`
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`I. George Serafin
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`Mr. Serafin is an expert in the areas of R&D, engineering, manufacturing, supply chain,
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`quality control/laboratory, quality assurance, regulatory, compliance, corporate/operations, and
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`information technology across pharmaceutical, biotechnology, medical technology, and consumer
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`healthcare. Mr. Serafin’s curriculum vitae is attached as Exhibit I.
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`Mr. Serafin may provide expert opinions and testimony regarding the appropriate remedy
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`in this Investigation, the appropriate amount of bond to be posted during the Presidential review
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`period, the requirements to increase or relocate production volume of any particular drug product
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`and components thereof and the related supply chain, manufacturing and regulatory requirements,
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`8
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`the public interest, and any other related issues pertinent to Regeneron’s defenses and Novartis’s
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`contentions for which expert testimony is required or useful. Mr. Serafin may also rebut the expert
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`witness report(s), opinions, and testimony of Novartis’s expert witness(es), if any, regarding these
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`matters.
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`
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`J. Larry Stevens
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`Mr. Stevens is an expert in the field of the regulatory approval of drugs and medical
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`devices. Mr. Stevens’s expertise includes expertise in the regulatory requirements necessary for
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`approval of a drug product and components thereof, including amendments or changes to the
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`manufacturing processes, components, supply chain, or facilities to an approved drug product, the
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`supply chains and development of drug product manufacturing facilities, and the validation and
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`quality control of manufacturing processes. Mr. Stevens’s curriculum vitae is attached as Exhibit
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`J.
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`Mr. Stevens may provide expert opinions and testimony regarding the appropriate remedy
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`in this Investigation, the appropriate amount of bond to be posted during the Presidential review
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`period, the requirements to increase or relocate production volume of any particular drug product
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`or component thereof and the related regulatory requirements, the public interest, and any other
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`related issues pertinent to Regeneron’s defenses and Novartis’s contentions for which expert
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`testimony is required or useful. Mr. Stevens may also rebut the expert witness report(s), opinions,
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`and testimony of Novartis’s expert witness(es), if any, regarding these matters.
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`9
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`Dated: November 13, 2020
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`Respectfully submitted,
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`
`
`
`
`/s/ Anish R. Desai
`Anish R. Desai
`Elizabeth Stotland Weiswasser
`Natalie Kennedy
`Andrew Gesior
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, New York 10153
`Tel: (212) 310-8000
`Regeneron_337ITC_Service@weil.com
`
`Brian E. Ferguson
`Robert T. Vlasis
`Christopher Pepe
`Priyata Y. Patel
`Matthew D. Sieger
`WEIL, GOTSHAL & MANGES LLP
`2001 M Street, NW, Suite 600
`Washington, DC 20036
`Tel: (202) 682-7000
`Regeneron_337ITC_Service@weil.com
`
`Attorneys for Respondent
`Regeneron Pharmaceuticals, Inc.
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`CERTIFICATE OF SERVICE
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`I hereby certify the foregoing RESPONDENT REGENERON’S IDENTIFICATION OF
`EXPERT WITNESSES was filed and served on this 13th day of November, 2020, by the
`indicated means, upon the following:
`
`The Honorable Lisa R. Barton
`Secretary to the Commission
`U.S. International Trade Commission
`500 E Street, S.W., Suite 112
`Washington, D.C. 20436
`The Honorable Clark S. Cheney
`Administrative Law Judge
`U.S. International Trade Commission
`500 E Street, S.W.
`Washington, D.C. 20436
`W. Peter Guarnieri
`Investigative Attorney
`Office of Unfair Import Investigations
`U.S. International Trade Commission
`500 E Street, S.W.
`Washington, DC 20436
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`Complainants Novartis Pharma AG, Novartis
`
`Pharmaceuticals Corporation, and Novartis
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`Technology LLC:
`
`
`Elizabeth J. Holland
`Goodwin Procter LLP
`The New York Time Building
`620 Eighth Avenue
`New York, NY 10018-1405
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`Via EDIS
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`Via Electronic Mail
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`Cheney337@usitc.gov
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`Via Electronic Mail
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`peter.guarnieri@usitc.gov
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`Via Electronic Mail
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`DG-NovartisPFS@goodwinlaw.com
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`/s/ Timothy J. Andersen
`Timothy J. Andersen
`Case Manager
`Weil, Gotshal & Manges LLP
`2001 M Street, N.W., Suite 600
`Washington, D.C. 20036
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`timothy.andersen@weil.com
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`EXHIBIT A
`EXHIBIT A
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`Mailing Address
`PO Box 899
`Belle Mead, NJ 08502-0899
`
`Agalloco & Associates
`Physical Address
`22 Carriage Trail
`Belle Mead, NJ 08502-4904
`
`
`James Agalloco
`
`[908] 874-7558
`Jagalloco@aol.com
`www.agalloco.com
`
`
`
`
`Forty+ years of management experience in pharmaceutical manufacturing, pharmaceutical process
`engineering, technical services and research and development. Internationally recognized expert on
`process validation, sterilization, aseptic processing, pharmaceutical manufacturing and isolation
`technology. Extensive knowledge of pharmaceutical, biological and API manufacturing technology.
`
`
`EXPERIENCE
`Agalloco & Associates, Belle Mead, NJ (12/91 to present) - President - Provides a wide range of
`technical services to the pharmaceutical, biotechnology and medical device industry in the areas of
`process and product validation, sterilization, aseptic processing, isolation technology, sterility
`assurance, compliance and facility design. Works closely with other consultants on larger projects.
`Assisted more than 200 clients in the United States, Puerto Rico, Western Europe and elsewhere.
`
`Bristol-Myers Squibb Technical Operations, New Brunswick, NJ (5/90 to 12/91) - Director, Validation
`and Technology - Directed validation, automation and technical documentation activities for BMS
`New Brunswick. Served as an important technical resource for worldwide pharmaceutical
`manufacturing. Active participant on product introduction and facility upgrade task forces.
`
`Squibb Technical Operations, New Brunswick, NJ (4/88 to 5/90) - Director, Worldwide Validation and
`Automated Technology – Responsible for Squibb facilities in 27 countries around the world. Served
`as major technical resource for facility design, facility start-up, sterilization, aseptic processing,
`validation and automation. Participated actively on major product, process, facility and equipment
`projects within STO. Directed the validation and automation phases of a $25 MM expansion of
`existing parenteral facility in New Brunswick. Major support provided to sterile bulk manufacturing.
`
`Pharmaceutical Engineering, Department Manager (2/80 to 4/88) - Managed the development,
`execution and documentation of validation efforts for STO worldwide. Served as the principal source
`of validation expertise within Squibb Corporation. Successfully led the validation of a $62 MM sterile
`facility through FDA review. Primary spokesperson for validation to FDA and other regulatory
`agencies. Responsible for validation of all dosage forms.
`
`
`Pfizer Pharmaceuticals, New York, NY (9/73-2/80)
`Engineering Project Manager (6/79-2/80) - Prepared capital project proposals for dosage form and
`BPC facilities. Provided facility planning, feasibility analysis, cost estimation, ROI and technical input.
`
`Senior Production Supervisor (9/75-6/79) - Managed production operations for sixty (60) different
`sterile and oral liquid and powder products. Major areas of responsibility included cost control, cost
`reduction, CGMP compliance, scheduling, equipment selection, and process trouble shooting.
`
`Manufacturing Engineer (4/74-8/75) - Formulated, piloted and scaled-up numerous pharmaceutical
`dosage forms. Coordinated technology review of new products from R&D to commercial sites.
`
`Research Engineer (9/73-4/74) - Managed the ongoing development and isolation of an anti-cancer
`agent from fermentation extract through finished bulk drug. Managed this activity part-time (1976 and
`1979) while serving full time in other capacities.
`
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`

`

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`Merck & Co., Rahway, NJ (3/71-8/73)
`Junior Chemical Engineer - Assisted in the scale-up/start-up and troubleshooting for new and existing
`bulk pharmaceutical chemicals. Served on API facility start-up team in Puerto Rico for 3 months.
`
`
`EDUCATION
`M.B.A. (Pharmaceutical Studies) Fairleigh Dickinson University, Teaneck, NJ, 1983
`M.S.Ch.E. Polytechnic Institute of New York, Brooklyn, NY, 1979
`B.E.Ch.E. Pratt Institute, Brooklyn, NY, 1968
`
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`MILITARY
`1st Lieutenant, United States Army (11/68-10/70) - Transportation Corps, served in continental United
`States and the Republic of Vietnam. Honor Graduate, TOBC 5-69.
`
`
`AFFILIATIONS
`USP, Member: Microbiology & Sterility Assurance Expert Committee, 2005-2020; lead author on
`revision of <1211> Sterilization & Sterility Assurance of Compendial Items.
`
`Parenteral Drug Association (1980 to present): Honorary Member; President; Second Vice President;
`Director; Chairman, Scientific Advisory Board; Committee Chairman; Interest Group Leader;
`Committee and Task Force Member; Course Leader; Speaker; Volunteer; Founder, Metro Chapter.
`
`Validation Discussion Group: Co-founder and Member, 1980 to present
`Pharmaceutical Manufacturers Association: Member, CSVC, 1983-1991
`International Society for Pharmaceutical Engineering - Member, 1980 to present
`
`SCIENTIFIC & EDITORIAL ADVISORY BOARDS
`Eniware – a developer of novel sterilization equipment – Scientific Advisory Board
`MedInstill – innovative developer of aseptic processing technologies – Scientific Advisory Board
`Pharmaceutical Technology – Editorial Advisory Board
`Pharmaceutical Manufacturing - Editorial Advisory Board
`
`PRESENTATIONS & TRAINING PROVIDED
`Presentations at numerous PharmTech, PDA, PhRMA, ISPE, ASQ and other industry meetings.
`Provides training courses on aseptic processing, sterilization and process validation domestically and
`internationally. In-house presentations and training sessions provided on a variety of subjects.
`
`PUBLICATIONS
`Co-editor, Validation of Pharmaceutical Processes, expanded third edition with 58 chapters,
`published in November 2007 by InformaUSA. Two prior editions published in 1986 &1997. Fourth
`edition is currently in-process.
`Co-editor, Advanced Aseptic Processing Technology, 42 chapter text, published August 1010 by
`InformaUSA.
`
`Authored or co-authored more than 40 book chapters and over 130 technical papers on: process
`validation, aseptic processing, sterilization, change control, sterility assurance, sterilization-in-place,
`cleaning validation, environmental monitoring, and isolation technology.
`
`
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`

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`Agalloco & Associates
`Agalloco & Associates is a New Jersey corporation led by James Agalloco, an internationally
`recognized expert on pharmaceutical technology, aseptic processing and process/system validation.
`A&A provides a wide range of technical services to the pharmaceutical and biotechnology industries.
`Our experience base includes all types of pharmaceutical dosage forms, medical devices, bulk
`pharmaceutical chemicals and biological products. A&A has particular expertise in the areas of
`validation, aseptic processing, sterilization, sterile bulk preparation, isolation / barrier technology,
`quality assurance and facility design. A&A draws upon a network of highly qualified individuals and
`organizations for the execution of larger tasks. A&A has assisted more than 200 clients since its
`founding in 1991.
`
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`Completed Assignments
`
`
`Aseptic Processing
`Review of current and future technology; evaluation of contract facilities; review of parenteral
`technology and regulatory compliance; in-house training of professional staff; evaluation of facility
`design concepts; development of environmental monitoring program; review of classified environment
`design proposal; facility modification and reopening; conversion of aseptic fills to terminal sterilization;
`assistance in regulatory compliance; assessment of international sites for US registration, evaluation
`of corporate policies and procedures; application of practices for medical devices; audit of admixture
`facilities; risk analysis for sterile products; design concept for pre-filled syringe manufacture;
`evaluation of aseptic sites for acquisition
`
`Biologics
`Assist in biological drug pre-approval inspection preparation; trouble shoot bioreactor contamination
`problem; conceptual design of isolator facility for fermentation / purification / formulation / filling;
`conceptual design review for facilities; application of isolation technology; review of facility and utility
`systems; definition of cleaning validation program; review of validation requirements for CGMP
`operations; development of environmental monitoring program; review of vaccine facility design and
`construction details; validation of aseptic processing; qualification of laboratory equipment; detailed
`design, validation and start-up of vaccine filling suite; design and validation of a blow-fill-seal facility;
`qualification / validation of cell processing facility; evaluation of contract manufacturers; pre-approval
`audits for bulk biological production; due diligence assessments
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`Bulk Pharmaceutical Chemicals / Active Pharmaceutical Ingredients
`Review of BPC validation requirements; validation of process control systems; review of design
`specification for distributed control system; definition of cleaning validation program; assistance in
`facility qualification / validation; validation master planning; assistance in aseptic processing and
`sterilization-in-place for sterile bulk operations; project manager for validation of BPC facility; review
`of Drug Master Files; conceptual development of facility renovation for sterile bulk operations; design
`review for sterile bulk manufacturing facility; development of protocols for production scale-up;
`assistance with regulatory interaction for sterile bulks; cost estimate for major API facility; design of
`sterile bulk packaging system
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`Isolation and Barrier Technology
`In-house training programs; assistance with liquid fill isolator qualification / validation; isolator based
`sterility test system validation; application of isolation technology concepts for clinical production;
`conceptual design of isolation technology based filling system; design concepts for integration of
`isolation technology to solid dosage formulation; validation master plan for cytotoxic parenteral
`facility; design and validation of microbial sampling system; application for medical device production;
`application for radio-pharmaceutical production; application for medical device pilot plant; design
`concept for parenteral pilot plant; applications for sterile API’s; design of systems for rapid
`decontamination
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`Medical Devices & Diagnostics
`Conceptual review of facility design; conduct custom validation training program; validation of
`controlled environments; validation of aseptic processing; design of environmental monitoring
`program; isolator based sterility test system validation; qualification / validation of medical device
`intermediates; application of isolation technology; review of cleaning validation program; assistance
`with clean room design, classification and operation; review of process validation program; regulatory
`submission of device sterilization methods; qualification of medical device production equipment;
`selection of clean room contractor; assistance with clean room injection molding; process design
`review for novel drug delivery system; integration of drugs and device manufacture on single site;
`preparation of corporate quality manual; assistance with component depyrogenation
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`Oral & Solid Dosage Forms
`Review of facility design concepts; development of cleaning validation program; cost estimate for oral
`products facility; review of standard operating procedures; evaluation of contract manufacturing site;
`assistance in manufacturing process development; validation support for non-sterile products facility
`start-up; validation protocols and reports for tablet products; validation of cleaning procedures; dust
`control assessment; development of environmental monitoring program; assistance with validation
`deviations; definition of microbial controls
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`Pharmaceutical Manufacturing
`SOP and validation audits; facility design reviews; sterile powder manufacturing technology; facility
`conversion from cephalosporin production; facility and equipment design review; qualification /
`validation of parenteral facilities; preparation and review of standard operating procedures; SOP
`preparation; preparation of components; pre-approval inspections; development of manufacturing
`instructions; facility layout assistance; troubleshooting ampoule filling; conceptual design for
`compounding area; evaluation of contract manufacturers; validation of manual and automated
`inspection; arbitration of client-CMO dispute
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`Processing Equipment
`Design and validation of sterilizer control systems; conceptual and detailed design of novel
`sterilization system; development of equipment manuals and qualification documentation; design of
`isolators for various applications; development of factory acceptance test protocols; bench-marking
`for injectable filling equipment; design of tanks for SIP compatibility; design of formulation / filling
`system for sterile suspension; design of SIP systems for process trains; design of self-contained
`sterilization equipment: design of H2O2 decontamination system
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`Regulatory Affairs & Compliance
`Assistance in regulatory interaction; assistance with FD 483 response; assistance with regulatory
`letters; assistance with regulatory interface; NDA submission preparation assistance; assistance with
`international regulatory compliance; critique of internal development reports prior to regulatory
`submission; validation readiness assessment; conduct of internal and external audits; screening
`formulations for terminal sterilization potential; actively participate in FDA meetings with clients;
`preparation of NDA sterilization sections for EEC submission; preparation of site reference file;
`assistanc