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`Case 1:18-cv-00924-CFC-SRF Document 563-20 Filed 11/09/20 Page 132 of 455
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`CONFIDENTIAL
`
` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC., and CITY OF HOPE, )
` )
` Plaintiffs, )
` )
` vs. ) Case No.
` ) 17-1407-CFC
`AMGEN INC. , )
` )
` Defendant. )
`__________________________________ )
`
` CONFIDENTIAL
` VIDEO-RECORDED DEPOSITION OF
` A. VERONICA CARVALHAL, PH.D.
`
` Thursday, May 30, 2019
` Palo Alto, California
`
`Reported By:
`Hanna Kim, CLR, CSR No. 13083
`Job No. 3404561
`
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`Case 1:18-cv-00924-CFC-SRF Document 563-20 Filed 11/09/20 Page 133 of 455
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`characterize when the cells are thawed and 09:53:04
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`maintained in a rolling C train by a reactor, and 09:53:07
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`then moving to four different stages of bio-reaction 09:53:13
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`or fermentation, where the cells are cultured, 09:53:18
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`brined [verbatim], and at some point that 09:53:26
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`bio-reaction is stopped. 09:53:28
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`BY MR. GUTMAN: 09:53:29
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` Q. So what stages would fall within the scope 09:53:29
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`of fermentation? 09:53:32
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` MR. McCLOUD: Object to form. 09:53:35
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` THE WITNESS: For the specific sentence 09:53:39
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`here, the purpose of the word "fermentation" 09:53:40
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`included inoculum train. I don't know if you -- if 09:53:48
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`you want further clarification of what is inoc 09:53:56
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`train, is steps to collect enough mass to be able to 09:54:00
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`move to the final stage of the cell culture process, 09:54:02
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`which is production. So in this specific sentence, 09:54:05
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`fermentation includes what we call inoc train and 09:54:10
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`production stage. 09:54:14
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`BY MR. GUTMAN: 09:54:15
`
`Q.
`And -- and I want to -- I want to discuss
`09:54:15
` Q. And -- and I want to -- I want to discuss 09:54:15
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`with you what your understanding is of the
`09:54:20
`with you what your understanding is of the 09:54:20
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`word "fermentation," not necessarily limited to the
`09:54:24
`word "fermentation," not necessarily limited to the 09:54:24
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`context of this sentence. So I'm trying to
`09:54:28
`context of this sentence. So I'm trying to 09:54:28
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`understand what your understanding of that term is,
`09:54:30
`understand what your understanding of that term is, 09:54:30
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`and how you would use it to describe the cell 09:54:34and how you would use it to describe the cell 09:54:34
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`culturing process. 09:54:39
`culturing process.
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` So with that in mind, you had previously 09:54:41
`So with that in mind, you had previously
`09:54:41
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`mentioned that fermentation is -- is a term used to 09:54:43
`mentioned that fermentation is -- is a term used to
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`define the process of culturing cells. And so, I'd 09:54:55
`define the process of culturing cells. And so, I'd
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`like for you to explain to me what is the definition 09:55:01
`like for you to explain to me what is the definition
`09:55:01
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`of fermentation, as you understand it, that defines 09:55:05
`of fermentation, as you understand it, that defines
`09:55:05
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`the process of culturing cells. 09:55:10
`the process of culturing cells.
`09:55:10
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` MR. McCLOUD: Object to form. 09:55:13
`MR. McCLOUD: Object to form.
`09:55:13
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` THE WITNESS: The way -- the way I define 09:55:19
`THE WITNESS: The way -- the way I define
`09:55:19
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`or understand fermentation or bio-reaction, two 09:55:47
`or understand fermentation or bio-reaction, two
`09:55:47
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`words that can be used interchangeably, includes the
`09:55:53
`words that can be used interchangeably, includes the 09:55:53
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`process of which to maintain cells in a way that
`09:56:04
`process of which to maintain cells in a way that 09:56:04
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`meets the final purpose, and this purpose can
`09:56:19
`meets the final purpose, and this purpose can 09:56:19
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`change. In a general description, would include to
`09:56:23
`change. In a general description, would include to 09:56:23
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`maintain cells in an environment, cells are healthy,
`09:56:31
`maintain cells in an environment, cells are healthy, 09:56:31
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`and, again, meets the purpose of a certain role.
`09:56:36
`and, again, meets the purpose of a certain role. 09:56:36
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`BY MR. GUTMAN: 09:56:49
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` Q. Are you finished with your answer? 09:56:49
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` A. Yes, yes. 09:56:51
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`Q.
`And -- and so, just -- I want to make sure
`09:56:52
` Q. And -- and so, just -- I want to make sure 09:56:52
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`I understand your response. So when you say it
`09:56:55
`I understand your response. So when you say it 09:56:55
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`meets the final purpose, which can change, those
`09:57:01
`meets the final purpose, which can change, those 09:57:01
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`purposes may be -- may be different across different
`09:57:04
`purposes may be -- may be different across different 09:57:04
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`products, for example; is that correct?
`09:57:10
`products, for example; is that correct? 09:57:10
`
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` MR. McCLOUD: Object to form. 09:57:12MR. McCLOUD: Object to form. 09:57:12
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` THE WITNESS: When I place the 09:57:13
`THE WITNESS: When I place the
`09:57:13
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`word "purpose," was not thinking products in 09:57:31
`word "purpose," was not thinking products in
`09:57:31
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`general. I was thinking that the final goal can be 09:57:34
`general. I was thinking that the final goal can be
`09:57:34
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`actual cells and not a protein. And sometimes the 09:57:40
`actual cells and not a protein. And sometimes the
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`goal is the protein. So it was more -- and then the 09:57:45
`goal is the protein. So it was more -- and then the
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`way you do the bio-reaction may change, depending on 09:57:51
`way you do the bio-reaction may change, depending on
`09:57:51
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`those goals. 09:57:54
`those goals.
`09:57:54
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`BY MR. GUTMAN: 09:57:55
`
` Q. So the goals may be different from 09:57:55
`Q.
`So the goals may be different from
`09:57:55
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`fermentation process to fermentation process, and 09:58:04
`fermentation process to fermentation process, and
`09:58:04
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`those goals will define what the fermentation
`09:58:08
`those goals will define what the fermentation 09:58:08
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`process is. Is that -- am I understanding your
`09:58:14
`process is. Is that -- am I understanding your 09:58:14
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`testimony correctly?
`09:58:18
`testimony correctly? 09:58:18
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`MR. McCLOUD: Object to form.
`09:58:19
` MR. McCLOUD: Object to form. 09:58:19
`
`THE WITNESS: Hmm. Shouldn't be so
`09:58:19
` THE WITNESS: Hmm. Shouldn't be so 09:58:19
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`complicated. So, fermentation or bio-reaction,
`09:58:35
`complicated. So, fermentation or bio-reaction, 09:58:35
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`which depending on the environment you are, they
`09:58:40
`which depending on the environment you are, they 09:58:40
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`mean -- or not the same. If you're in the research
`09:58:45
`mean -- or not the same. If you're in the research 09:58:45
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`world or company world, sometimes it's used either
`09:58:47
`world or company world, sometimes it's used either 09:58:47
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`the same way or in different ways. Overall, the
`09:58:51
`the same way or in different ways. Overall, the 09:58:51
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`baseline of a bio-reaction or fermentation, it has a
`09:58:57
`baseline of a bio-reaction or fermentation, it has a 09:58:57
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`common -- common facts. In cells, you need a
`09:59:04
`common -- common facts. In cells, you need a 09:59:04
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`system. You need to control that system in some
`09:59:10
`system. You need to control that system in some 09:59:10
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`sort, with more detail or less detail. You need to
`09:59:16
`sort, with more detail or less detail. You need to 09:59:16
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`provide the right nutrients to the cells. And you 09:59:18provide the right nutrients to the cells. And you 09:59:18
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`need to ensure that that step of bio-reaction meets 09:59:24
`need to ensure that that step of bio-reaction meets
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`the goal, which may be to recover product like a 09:59:30
`the goal, which may be to recover product like a
`09:59:30
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`protein, or just have very healthy cells in the end. 09:59:36
`protein, or just have very healthy cells in the end.
`09:59:36
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`BY MR. GUTMAN: 09:59:46
`
` Q. Now, sticking on your resume, the last 09:59:53
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`bullet point on the first page, you make reference 09:59:56
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`to having hired, coached, and managed three 09:59:59
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`scientists/engineers and four co-op students. 10:00:04
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` Do you see that? 10:00:08
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` A. I do see it. 10:00:08
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` Q. Who are the three scientists/engineers 10:00:10
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`that you hired and coached? Can you name them for 10:00:13
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`me? 10:00:16
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` A. One was Rakesh Motani, Lauren Feeney or 10:00:17
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`Lauren Brown, and Thomas DiRocco. 10:00:31
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` Q. And it's going to be hard for me to try to 10:00:35
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`repeat the last name of the first person that you 10:00:41
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`mentioned. Can you spell that person's last name 10:00:45
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`for me? 10:00:48
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` A. Let me think to be sure that I don't say 10:00:49
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`it wrong. M -- the first person, Rakesh? 10:00:57
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` Q. Yes. 10:01:00
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` A. M-O-T-A-N-I, I think. I'm not 100 percent 10:01:01
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`sure. It's been a long time. 10:01:11
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`Chapter 6 for which you're an author, was published 05:23:02
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`in 2012; is that correct? 05:23:08
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` A. Yep, seems like. 05:23:09
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` Q. Now, can you turn to page 96 of the 05:23:14
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`article? 05:23:36
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` A. 96. Yes. 05:23:44
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` Q. Now, in figure 6.3, for the caption, you 05:23:49
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`refer to a typical CHO-derived antibody 05:23:53
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`manufacturing process production. 05:23:56
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` Do you see that? 05:23:58
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` A. I do see it. 05:23:59
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`Q.
`And in the figure that is figure 6.3, you
`05:24:01
` Q. And in the figure that is figure 6.3, you 05:24:01
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`show a harvest centrifugation filtration step that
`05:24:03
`show a harvest centrifugation filtration step that 05:24:03
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`immediately -- that is immediately after the
`05:24:11
`immediately -- that is immediately after the 05:24:11
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`production stage.
`05:24:16
`production stage. 05:24:16
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`Do you see that?
`05:24:17
` Do you see that? 05:24:17
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`MR. McCLOUD: Object to form.
`05:24:18
` MR. McCLOUD: Object to form. 05:24:18
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`THE WITNESS: So this diagram represents
`05:24:22
` THE WITNESS: So this diagram represents 05:24:22
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`the step of harvest that would follow a production
`05:24:24
`the step of harvest that would follow a production 05:24:24
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`stage.
`05:24:28
`stage. 05:24:28
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`BY MR. GUTMAN:
`05:24:28
`BY MR. GUTMAN: 05:24:28
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`Q.
`And that's a typical CHO-derived antibody
`05:24:28
` Q. And that's a typical CHO-derived antibody 05:24:28
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`manufacturing production process, correct?
`05:24:31
`manufacturing production process, correct? 05:24:31
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`A.
`Today, I would say that is no longer -- is
`05:24:37
` A. Today, I would say that is no longer -- is 05:24:37
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`the most necessarily typical, but I'd say it's a
`05:24:40
`the most necessarily typical, but I'd say it's a 05:24:40
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`good representation, a schematic representation or a 05:24:45good representation, a schematic representation or a 05:24:45
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`simplified representation of what a manufacturing 05:24:47
`simplified representation of what a manufacturing
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`production process could look like. 05:24:50
`production process could look like.
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` Q. And over here in -- in figure 6.3, you're 05:24:53
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`referring to the harvest step as involving 05:24:56
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`centrifugation and filtration, correct? 05:24:59
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` A. Yes. 05:25:04
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` Q. If you turn to page 97, the next page, and 05:25:04
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`table 6.1, you go down and you see it refers to the 05:25:08
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`harvest process stage. 05:25:14
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` Do you see that? 05:25:18
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` A. The last line? 05:25:19
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` Q. In table 6.1, yes. 05:25:21
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` A. Yes. 05:25:23
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` Q. And in connection with harvest, the 05:25:23
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`parameter or process attribute that you describe is 05:25:26
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`cell lysis. 05:25:30
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` Do you see that? 05:25:31
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` A. I do see that. 05:25:32
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` Q. Why are you referring to cell lysis during 05:25:33
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`the harvest process stage? 05:25:37
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` MR. McCLOUD: Object to form. 05:25:41
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` THE WITNESS: I need to remember the 05:25:42
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`introduction of this table. 05:25:44
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` Okay. I can answer. So this table 6.1 -- 05:26:42
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`Case 1:18-cv-00924-CFC-SRF Document 563-20 Filed 11/09/20 Page 139 of 455
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`CONFIDENTIAL
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` CERTIFICATE OF REPORTER
`
` I, Hanna Kim, a Certified Shorthand
`
`Reporter, do hereby certify:
`
` That prior to being examined, the witness
`
`in the foregoing proceedings wa