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PROGRAM CHAIRS:
Alissa M. Resch, PhD - Coriell Institute for Medical Research
Fang Tian, PhD - American Type Culture Collection (ATCC)

Jamie Almeida
Research Biologist, Biochemical Science Division, Bioassay Methods Group
National Institute of Standards & Technology (NIST)
Mouse Cell Line Authentication Consortium Update

Abstract

Misidentified and contaminated cell lines continue to persist in the scientific community. Standard methods are in place for human cell line authentication; however, standards for non-human cell lines are lacking. NIST has partnered with ATCC to validate short tandem repeat (STR) markers developed at NIST for identity testing of mouse cell lines by establishing the Mouse Cell Line Authentication Consortium. This is a collaboration between 13 labs and involves an interlaboratory study to test 50 of the most commonly found mouse cell lines using 19 mouse STR markers. The consortium members were provided a kit containing a master mix, multiplex primers, mouse DNA, a human control, and calibrants. PCR will be used to amplify the target STR markers and these amplicons will be separated using capillary electrophoresis. Each lab will process the samples based on the instrumentation found in their labs which include various models of fragment analyzers, different arrays, and polymers. The fragment analysis data will be analyzed using various software platforms and submitted to NIST upon completion. The results from this consortium will lead to the development of a public STR database for mouse cell lines, and ultimately a written consensus standard for mouse cell line authentication.

Biography

Jamie Almeida received a Bachelor of Science in Microbiology from Arizona State University and a Master of Science in Biotechnology with a concentration in Biodefense from the Johns Hopkins University. She has worked at NIST since 2004 in the Bioassay Methods Group, part of the Biosystems and Biomaterials Division. Some of her past contributions include: 1) stability studies for B. anthracis Sterne spores, 2) development of a rapid bioassay test for ricin using a GFP expressing cell line, and 3) decontamination of various biothreat agents in water systems in the presence and absence of pipe biofilms. Jamie has worked closely with the DNA forensics group at NIST since 2010 learning to separate short tandem repeat alleles using capillary electrophoresis and optimizing multiplex PCR assays. Using this knowledge, she has focused her efforts on the identification of non-human cell lines, specifically monkey, mouse, hamster, and rat.

Joaquina Mascarenhas, PhD
Senior R&D Scientist/Team Lead, MilliporeSigma
Adventitious Agent Risk Mitigation: Engineering
Minute Virus of Mice Resistance into CHO Cells

Abstract

Contamination by the parvovirus minute virus of mice (MVM) remains a continuing challenge in Chinese hamster ovary (CHO) biopharmaceutical production processes. As part of developing a risk mitigation strategy against such events our group has evaluated the genetic engineering of CHO cell lines to create a new host cell line that would be resistant to MVM infection e.g. by inhibiting viral attachment to a cell surface receptor. While the exact functional receptor for MVM binding to CHO cell surface is unknown, previous work in our group has validated the role of sialic acid on the cell surface as important for cell surface binding and internalization of the MVM virus.

Deletion of the CMP-sialic acid transporter Slc35a1 abrogated cell surface binding and internalization of the MVM virus and resulted in complete resistance to MVM infection. Slc35a1 mutants were compared to the wild-type (WT) cells for growth, productivity, and product quality at a 2 L benchtop bioreactor scale. Model recombinant proteins were transfected into the new host cell lines and growth, IgG productivity, and product quality studied. Slc35a1 mutant cell lines were found to be similar to WT cells lines and the monoclonal antibody products, while devoid of terminal sialic acid, had comparable product quality attributes to WT-produced proteins. In more complex glycoproteins, elimination of sialic acid could have a clinical impact. Since MVM preferentially binds to α-2,3 sialylated glycans, we replaced all α-2,3 sialylation with an α-2,6 sialylation phenotype and tested for resistance. Replacing the α-2,3 linked sialic acid with α-2,6 linked sialic acid maintained complete resistance to MVM infection. Gene knockouts targeting viral entry, virus transport, and replication were also tested for MVM resistance. In vitro MVM pull-down assays, whole genome Crispr screens, etc. are ongoing to identify other targets for engineering MVM resistance. As efforts to create better and safer CHO host cell lines continues, the incorporation of viral resistance in host cell lines results in adding greater assurance of production of safely delivered cell-derived products.

Biography

Dr. Joaquina Mascarenhas received her PhD in Biopharmaceutical Sciences from the University of Illinois at Chicago. From there she moved on to a postdoctoral position at Wyeth Biotech (Pfizer) in Andover, Massachusetts. Her current role at MilliporeSigma is as a team lead for research and development focused on next-generation expression systems for the manufacture of recombinant therapeutic proteins and cell-based vaccines. Gene editing tools such as zinc finger nucleases and Crisprs are employed for engineering new host cell lines with superior attributes such as improved product quality, higher productivity, and shorter development timelines. Dr. Mascarenhas is a co-author on publications and is the recipient of patents in the field of CHO host cell engineering related to glycosylation and improved product quality. She is currently leading a team of scientists in the product development of a genetically engineered CHO host cell line that is resistant to viral contamination.

Yvonne A. Reid, PhD
Program Chair Emeritus
Best Practices to Consider for Naming Cell Lines

Abstract

When establishing a new cell line from a tissue sample, or deriving a variant of an existing cell line, it is very important to consider the name or designation of the cell line early in the process. Cell line names that are too long can lead to transposition errors, while cell lines that are too short are not easily searchable and may lead to duplication. Often times a cell line name on the vial in storage may not be traceable to the original tissue or may be different from that used in publications. Changes in the cell line name or inconsistent use of the name oftentimes becomes confusing, leading to mislabeling and misidentification of a cell line and subsequent unreliable data in the scientific field.

Biography

Dr. Reid’s research focuses on the use of DNA hypervariable probes for the intraspecies identification of cell lines. The evolution of this work has led to the implementation of routine screening of all human cell lines by STR analysis. She co-chaired the ATCC Standards Development Organization (SDO) committee on the Development of a Consensus Standard for the Authentication of Human Cell Lines: Standardization of STR Profiling. Dr. Reid has more than 37 years of experience in cell biology, immunology, and molecular biology. As former Head of the Cell Biology Collection, she was responsible for acquisition, expansion, and quality control of new animal cell lines and hybridomas brought into the Cell Biology General Collection. Dr. Reid has authored over 40 peer-reviewed publications and has served on more than a dozen scientific committees, including serving as an ad hoc member of the Comparative Medicine Review Committee. Dr. Reid has served as principal investigator on eight government and non-government contracts. She has been invited to speak, convene, and/or chair sessions at several cell biology conferences sponsored by the American Association for Cancer Research (AACR), ISBioTech, Society for Biomolecular Sciences (SBS), Society for In Vitro Biology (SIVB), International Society for Stem Cell Research (ISSCR), Parenteral Drug Association (PDA), Bioassay and Bioanalytical Methods Development, Select Biosciences-CELLCullture, and Histochemical Society (HCS).

Glenn MacIsaac
Senior Scientist, Outsourcing Cell Banking and Cell Line Development
Bristol-Myers Squibb Company
A Master Cell Bank (MCB) Troubleshooting Case Study:
Challenges and Process Improvements with Comprehensive Root Cause Analysis

Abstract

Mammalian cells, especially Chinese hamster ovary (CHO) cells, are routinely used in the biopharmaceutical industry for production of recombinant therapeutic proteins. Master cell banking is one of the key steps during drug development, which ensures preservation of cells at low temperatures for an extended period of time for GMP drug substance manufacturing. CHO cells can show significant variation in growth characteristics during cell line development. This variation necessitates the need for a robust master cell bank (MCB) manufacturing process to ensure consistent MCB thaw and growth.

Numerous efforts have been made to understand the cryopreservation mechanism as well as techniques to improve the robustness of banking processes. However, failure of MCB releasing still happens across the industry. A case study will be presented highlighting experiments carried out to identify root cause of MCB thaw and expansion variability. In this study, the health of the cells was examined using an apoptosis assay and transmission electron microscopy (TEM) analysis to gain a better understanding of cell bank health. Process improvements that included further passaging of the cell line for improved robustness of the MCB manufacturing process will be discussed.

Biography

Glenn MacIsaac has more than 24 years of industrial experience working for biotech and pharmaceutical companies in Scotland, Canada, and the United States. For the past 18 years Glenn has been working for Bristol-Myers Squibb/Medarex specializing in cell line development, master and working cell bank manufacture, cell bank testing and characterization, and health authority filing authoring and review. Glenn’s group is also responsible for the outsourcing of cell line development and cell banking manufacture. Highlights of Glenn’s career are having worked on two commercially approved drugs Yervoy and Opdivo from cell line development through the biologics license application (BLA) approval process.

Lisa V. Kalman, PhD
Senior Advisor for Repository Science, Laboratory Research and Evaluation Branch
Centers for Disease Control & Prevention (CDC)
The Genetic Testing Reference Materials Coordination Program (GeT-RM):
Translating Reference Material Needs into Reality!

Abstract

The issue:
Reference materials are essential for many aspects of genetic testing. They can be used as controls, which are tested alongside patient samples to detect errors as part of the laboratory’s quality control (QC) program. Reference materials are also needed for test development and validation, lot-to-lot testing of new reagent lots, and for proficiency testing/external quality assessment (PT/EQA).

The problem:
Over 35,000 genetic tests covering over 4,100 genes for more than 10,000 conditions are currently offered by clinical laboratories, however there are no publicly available well-characterized reference materials for the vast majority of these tests. This results in the laboratory having to use materials that may be suboptimal in establishing the quality of tests offered or develop and run assays without adequate controls. This can compromise the quality of the genetic test and makes it difficult to meet regulatory requirements.

Our solution:
In an effort to address this issue, the Centers for Disease Control and Prevention (CDC), in partnership with the genetics community, established the Genetic Testing Reference Materials Coordination (GeT-RM) Program. The goal of this program is to coordinate a self-sustaining community process to increase the availability of characterized genomic DNA materials for quality control, PT/EQA, test development/validation, and research. Although the GeT-RM Program is coordinated by CDC, all of the actual work, including decisions about reference material priorities, specimen collection, material development, and characterization occurs through voluntary collaborations with laboratories in the genetics community.

Our outcomes:
Since 2004, the GeT-RM program has characterized more than 4,600 loci in over 400 cell line-based genomic DNA reference materials for a number of genetic disorders and markers, including fragile X, 9 disorders on the Ashkenazi Jewish panel, cystic fibrosis, Huntington's disease, Duchenne muscular dystrophy, myotonic dystrophy, Rett syndrome, and pharmacogenetic polymorphisms. Each of these genomic DNA materials was tested by between three and ten laboratories using a variety of genetic assays, including DNA sequence analysis. These materials are publicly available from the Coriell Cell Repositories. The GeT-RM is currently developing reference materials for genomic sequencing and analysis of the human leukocyte antigen (HLA) loci. GeT-RM reference materials have been used by laboratories for assay development, validation, and QC as well as by PT/EQA programs for use as PT samples. Use of these samples has helped to ensure the quality of an increasing number of genetic tests.

Biography

Lisa Kalman directs the Genetic Testing Reference Material Coordination Program (GeT-RM) at the Centers for Disease Control and Prevention (CDC) in Atlanta Georgia. Dr. Kalman earned her BS degree in Biology and her PhD in Microbiology and Molecular Genetics from the University of California, Los Angeles. She also completed a postdoctoral fellowship at Stanford University in Developmental Biology and Biochemistry. As the Coordinator of the GeT-RM Program, Lisa partners with members of the genetic testing community to manage a voluntary, sustainable process to improve the quality of clinical genetic testing. The GeT-RM program helps the genetics community to identify appropriate, well characterized reference materials through coordinated information exchanges between testing laboratories and providers of reference materials. The program also initiates and coordinates the contribution, development, characterization, and distribution of new reference materials for genetic testing. She is also the Science Advisor for the CDC’s sample repository. Dr. Kalman has authored a number of guidance documents related to molecular genetic testing.

Douglas R. Storts, PhD
Head of Research, Nucleid Acid Technologies, Promega Corporation
Human Cell Line Authentication

Abstract

Cell line misidentification is a major concern affecting scientific research. As reports of misidentification have surfaced, there have been calls for greater diligence in characterizing the cell lines prior to publication. A growing number of journals now require submitting authors to authenticate their cell lines. The ATCC Standards Development Organization released a consensus standard for human cell line authentication based upon the use of short tandem repeat (STR) loci (Authentication of Human Cell Lines: Standardization of STR Profiling [ASN-0002]). I will discuss the extent of the problem as well as methods used to confirm the identity of human cell lines.

Biography

Doug Storts is the Head of Research - Nucleic Acid Technologies at Promega Corporation. He joined Promega Corporation in 1991. Doug is responsible for strategy and implementation related to the development of reagent systems for nucleic acid amplification, expression analysis, DNA sequencing, and genotyping (human forensic, paternity, clinical research, and cell authentication), as well as managing external consultants and collaborators. Doug has co-authored more than 35 peer-reviewed manuscripts and approximately 55 articles and book chapters in non-refereed journals and books. He has presented numerous lectures and posters at national and international meetings, and is a co-inventor on several issued and pending patents. Doug has served as an invited lecturer for the University of Wisconsin–Madison, an ad hoc reviewer for several scientific journals and has participated on committees establishing national and international scientific policy. Doug received his Bachelor of Science degree in Biology at Manchester College, and his Master of Science degree and PhD in Microbiology at Miami University in Ohio. Thereafter, he was a postdoctoral research associate and instructor in the Department of Biochemistry and Molecular Biology at the University of Chicago.

Fang Tian, PhD
Lead Scientist, Cell Biology Group Leader, ATCC Cell Systems
American Type Culture Collection (ATCC)
Characterization and Banking of CRISPR-Generated Isogenic Cell Lines

Abstract

Large-scale genome programs have generated a wealth of data regarding the genetic abnormalities observed in thousands of clinical patient samples. Translation and validation of the importance of these genetic abnormalities in the etiology and potential treatment of cancer is often accomplished using relevant in vitro models. CRISPR, the most facile and versatile of all the gene editing technologies available today, enables precise modifications in the genomes of eukaryotic cells. Isogenic human cell lines created by CRISPR genome editing provide an ideal platform for biofunction studies of targeted genes, as well as cell-based drug screening. In this talk, ATCC human isogeneic cell lines created using CRISPR genome editing technology will be introduced. The multiple levels of molecular and bio-functional characterizations of those new cell models containing the cancer related gene rearrangement or point mutations will be discussed. Moreover, the STR testing of the cell banks from CRISPR technology-generated isogenic cell lines will be addressed.

Biography

Dr. Fang Tian, Lead Scientist, is the head of the Cell Biology Collection at ATCC. Dr. Tian has extensive experience in cell biology and molecular biology, cell banking and bioprocessing. She is responsible for overseeing over 3,400 human and animal cell lines and hybridomas in the Cell Biology General Collection. Her R&D team has been accessing scientific high-value cell lines from various species, as well as developing advanced cell models focusing on disease, molecular signatures, cell signaling pathways, and genetic alteration. Her previous research field covers cancer genomics, programmed cell death, neovascularization, stem cell and progenitor cell differentiation, as well as anti-cancer drug screening. Dr. Tian was a research fellow in Massachusetts General Hospital, Harvard Medical School. She conducted postdoctoral research at the Hillman Cancer Institute at the University of Pittsburgh Medical Center. Dr. Tian obtained her PhD degree from Chinese Academy of Sciences.

Kelvin G.M. Brockbank, PhD
CEO, Tissue Testing Technologies LLC
Ice-Free Cryopreservation of Natural and Engineered Tissues

Abstract

Preserved natural tissues and engineered constructs using traditional freezing methods of cryopreservation is subject to ice damage. We have developed methods for preservation of tissues using ice-free vitrification. The original vitrification protocol has evolved over time. Ice-free cryopreservation using a 55% cryoprotectant formulation with multistep addition/removal and storage below -135°C is limited to small samples where relatively rapid cooling and warming rates are possible. This method typically provides extracellular matrix preservation with at least 80% cell viability and tissue function compared with fresh untreated tissues. It has proven effective for a variety of natural tissues including heart valves and articular cartilage. Modifications of the original protocol have proven very effective for a variety of engineered tissues including blood vessel and epithelial constructs. Employing EpiDerm, EpiOcular, and EpiCorneal constructs we have excellent viability by alamarBlue and MTT assays plus transepithelial resistance and Triton X-100 cytotoxicity curves compared with fresh untreated constructs. We have developed two approaches for larger samples. Depending on the protocol we can either retain most of the cells alive with preservation of extracellular matrix or we can minimize viable cells and decrease the risks of post-transplant immunoreactivity. This method employs the use of higher concentration, ±83%, cryoprotectant formulations, simpler addition and removal protocols, and storage at -80°C. In conclusion: ice-free vitrification protocols can be adapted to tissue product needs providing effective methods for storage. We are prepared to work with potential licensees to adapt our technology to their product applications.

Biography

Dr. Kelvin G.M. Brockbank, CEO and Founder of Tissue Testing Technologies LLC, is a Research Professor of Bioengineering at Clemson University and Adjunct Professor of Regenerative Medicine and Cell Biology at the Medical University of South Carolina. His research interests include cell, tissue, and organ cryopreservation for test systems and transplantation and manufacturing methods for cell-based tissue engineered products. His work has led to the establishment of two successful publicly traded low temperature technology platform companies, CryoLife, Inc. and Lifeline Scientific. Dr. Brockbank’s most recent company, Cell and Tissue Systems, Inc., was acquired in December 2014 for its intellectual property portfolio. He also has delivered over 500 patents, book chapters, journal articles, and presentations at national and international conferences. He was the recipient of the “George W. Hyatt Memorial Award” for superior service in the fields of tissue banking and human transplantation in 2009 and is currently Vice Chairman of the Scientific and Technical Affairs Committee of the American Association of Tissue Banks.

Christine Mitchell, PhD
Sr. Scientist, WuXi AppTec Inc.
Cell Line Authentication: Species Identity and
Purity Analysis Using Next Generation Sequencing

Abstract

Regulatory agencies expect thorough characterization of cell banks used to produce biological products. WuXi AppTec has developed a purity assay to evaluate cell lines for contamination by other cell species that complements our existing validated cell line identity assay. The cell line identity method uses WuXi AppTec designed primers to target species-specific sequences within protein-coding genes located on nuclear chromosomes and mitochondrial DNA. In addition, the assay includes control primers to target sequences that are conserved across species to control for the assay methodology. The species-specific primers and control primers are combined into a multiplex PCR to amplify target sequences from test article cells. The amplicons are analyzed by next-generation sequencing, sequencing results are evaluated against a WuXi AppTec cell line identification database, followed by BLAST analysis to confirm best species match. The purpose of the cell line identity assay is to identify the cell line origin of test article cells. WuXi AppTec has expanded the cell line identity approach to include a purity analysis that examines test article cells for the presence of 18 potentially contaminating species. This new purity assay can detect cross contamination at <1% of the total cell population.

Biography

Christine received a PhD in Molecular Genetics from the State University of New York at Stony Brook. She has worked at WuXi AppTec since 2007, first in the Viral Clearance Group where she developed viral qPCR assays. In 2012, she joined the Technical Development group where she contributed to the development of 1) AgentSCREEN™ and AgentID™ assays to detect adventitious viruses using next-generation sequencing (NGS), 2) cell line identity and purity assays using NGS, and 3) gene copy titer assays for gene and cell therapy products using qPCR and droplet digital PCR, as well as various other complex molecular biology methods.

James M. Clinton, PhD
Scientist, ATCC Cell Systems, American Type Culture Collection (ATCC)
Next-Generation Cancer Models: Challenges in Scale-Up
and Cell Banking for Global Distribution

Abstract

The scientific community has recognized that currently available preclinical cancer models are inadequate for the study of cancer biology, drug discovery, personalized therapeutics, and biomarker identification. This can be attributed to an insufficient diversity of available models, as well as the realization that existing models often lack biological and genetic relevance to tumors in vivo. To address these deficiencies, advanced culture methodologies are being utilized to generate novel primary tissue- derived models from cancers that are underrepresented by existing cell lines. Here we provide an overview of some of the technologies driving the development of these “next-generation” models that are poised to transform in vitro cancer research. We will also share our experience with some of these methods and models as part of our involvement with the Human Cancer Models Initiative (HCMI), an international collaborative effort to develop 1000 new human cancer models which will be distributed by ATCC.

Biography

James Clinton is a Scientist at ATCC Cell Systems (ACS), the research and development division of American Type Culture Collection (ATCC). Since 2013 he has worked within the Primary and Stem Cell group focusing on the development of novel cell biology tools with an emphasis on physiologically relevant in vitro models. His team has been responsible for expanding ATCCs primary tissue derived cells portfolio, the creation of genetically engineered cell lines for in vitro cell based assays, the generation of terminally differentiated iPSC-derived cells, as well as exploring emerging culture techniques such as three-dimensional organoids. James attended University of California San Diego and Washington State University and currently serves as technical lead for the team at ACS working with the novel cancer models being produced by the Human Cancer Models Initiative.

John M. Baust, PhD
President, Founder, and Lead Scientist, CPSI Biotech
Strategies and Trends for Improving Sample Quality Following Cryopreservation

Abstract

Cryopreservation (CP) plays an integral role in a variety of bioprocessing, biotechnology, and medical applications. While a critical tool, CP protocols, approaches, and technologies have evolved slowly over the last several decades. While the adoption of new approaches to CP has been slow, discoveries including molecular modulation and the development of new devices for improved sample freezing and thawing are providing new strategies for improving CP. To this end, we are developing a series of new devices and protocols to enable the rapid and controlled freezing (SmartFreeze) and thawing (SmartThaw) of samples. These systems are designed to improve sample viability and function post-thaw while reducing processing time and end-user variability. Further, the importance of CP optimization based on biophysical events is well recognized. In addition, however, the acute influence of cell stress pathways activated in response to CP post-thaw, which are linked to the activation of cell death signaling cascades, are of equal importance to recovery. Studies continue to illustrate the impact and benefit of controlling cryopreservation-induced delayed-onset cell death (CIDOCD) through various approaches, including new media and cryoprotective agents (CPAs), molecular control and buffering of cell stress response, and new devices to improve sample recovery and quality. The majority of these efforts focus on new “front end” technologies, such as specialized media or new protective agents. Given the known impact of CIDOCD over the initial 24–48 hour post-thaw recovery phase, we are developing a series of new molecular based post-thaw conditioning strategies and technologies (RevitalICE) to reduce the impact of CIDOCD in an effort to improve recovery of cryopreserved samples. These findings suggest that there is a viable path for improving recovery of samples through the modulation of cell stress response during both the pre-freeze and post-thaw recovery intervals. This presentation will discuss development efforts focusing on the impact of targeted modulation of the cellular-molecular response to cryoinjury as a path to improve recovery and function as well as the benefit of new thawing devices for improving the recovery of samples. Data presented will include thermal profile, cell viability, and molecular stress results from several cell systems including various cell lines as well as human stem cells (hHSCs, hMSCs). The results suggest that the utilization of these approaches enable more efficient, controllable sample processing and greater sample viability and functionality in comparison to traditional methodologies.

Biography

John M. Baust, PhD is the Founder, President, and Lead Scientist of CPSI Biotech. Dr. Baust has over 15 years’ experience in research & medical device development and is a co-inventor on over 30 patents. Dr. Baust is a recognized innovator and entrepreneur in cryomedicine and is a pioneer in the area of molecular mechanisms of cell death and low temperature stress. Dr. Baust has published over 100 papers, reviews, book chapters, abstracts, and patents in the area of low temperature biology and has been instrumental in the advancement of the field of cryobiology into the molecular biological era focusing on signal transduction and apoptosis. In this regard, Dr. Baust is credited with the discovery of cryopreservation-induced delayed-onset cell death. In the area of research and technology development, Dr. Baust has led the development of numerous medical devices, including the Supercritical Nitrogen (SCN) and Pressurized Nitrogen (PSN) cryoablation devices for the treatment of cancer and cardiac arrhythmias. This is in addition to spearheading the development of the SmartThaw and SmartFreeze devices for improved cell and tissue cryopreservation. Coupled with these technical engineering developments, he leads life science research programs focused on the cell-molecular actions of cryoablation. These efforts have resulted in the identification of a significant molecular stress response component to freezing injury which is responsible for the differential sensitivity of various cancers to thermal ablation. In addition to these activities, Dr. Baust serves on the editorial boards of Biopreservation and Biobanking as well as Technology in Cancer Research and Treatment (TCRT), and is a reviewer for several other scientific journals. Dr. Baust co-edited the book Advances in Biopreservation, is a past board member for the Society for Cryobiology, and currently serves on the Board and as Treasurer of the American College of Cryosurgery. Dr. Baust completed his studies at Cornell University, State University of New York at Binghamton, and Harvard Medical School.

Kamalpreet Arora, PhD
Science and Standards Liaison, Global Biologics
US Pharmacopeial Convention (USP)
Cell Banking Best Practices for Mammalian and Bacterial Cell Lines for Biotherapeutics

Abstract

The United States Pharmacopeial Convention is an independent scientific organization that protects public health through documentary, physical, and performance standards for drugs and biologics. As biological science contributes to more advanced therapies, standards continue to play a critical role in drug development and manufacturing. USP’s new informational chapter on cell banking includes best practices for generating bacterial and mammalian cell lines and points to consider on clonal derivation of the cell lines used in the manufacturing of biotherapeutics with a goal of a controlled and consistent manufacturing process. The chapter elaborates on the principles noted in ICH and US FDA guidances including: cell line homogeneity, reproducibility, history, cell bank generation and qualification, characterization, genetic stability, storage, raw materials, and reagent qualification.

Nahid Turan, PhD
Director, Laboratory Operations, Coriell Institute for Medical Research
Quality Considerations for Reference Materials

Biography

Nahid Turan, PhD, is principal investigator at Coriell Institute for the NIGMS Human Genetic Cell Repository, an extensive collection of more than 11,460 cell lines and 5,900 DNA samples representing a variety of disease states, chromosomal abnormalities, and healthy individuals across numerous distinct human populations. In this role, Nahid oversees all aspects of the NIGMS Repository management, making strategic decisions as needed to optimize efficiency and productivity. Nahid manages the scientific operations of the biobank, recruits new samples, identifies new directions, and interfaces with governmental project officers and scientific advisory committee members. She prepares progress reports, oversees the budget, supervises the NIGMS Repository Project Managers and Genetic Counselor, and interfaces with laboratory managers and other departments to ensure that the project scope of work and objectives are achieved.

Nahid is also the principal investigator of the Congenital Heart Disease GEnetic NEtwork Study (CHD GENES) Biorepository at Coriell Institute, which is funded through the National Heart, Lung, and Blood Institute (NHLBI). Prior to joining Coriell Institute, Nahid was Associate Scientist at the Fels Institute for Cancer Research and Molecular Biology at Temple University School of Medicine in Philadelphia, where she also completed six years postdoctoral training in Epigenetics and Molecular Biology. Nahid earned her Bachelor's (Honors) in Biochemistry, Master's in Toxicology, and Doctorate in Biochemistry and Molecular Biology from the University of Birmingham in the United Kingdom.

Shuo-Hung "Jack" Hsiao, PhD
Scientist, Stem Cell Biology, Coriell Institute for Medical Research
Establishment and Maintenance of iPSC Distribution Banks
Paula Keskula
Operations Leader for the Cell Line Factory, Broad Institute


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