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PepTalk Q&As 2015

Anticipating Stability Challenges for Biotherapeutics: Characterizing Aggregation Propensity and Formation of Subvisible Particles

with Joël Richard, Ph.D., Senior Vice President, Peptides, Head of CMC Dreux Site, Ipsen

Nandini Kashyap interviews Dr. Joël Richard of Ipsen on October 23, 2014. Dr. Richard will be speaking during the Inaugural Detection and Characterization of Particulates and Impurities conference which takes place on January 21-22 at the upcoming PepTalk event which runs from January 19th to 23rd, 2015 in San Diego, CA.

Topics Include: Protein aggregation, Sub-visible particles, Protein stability, Orthogonal tools, biophysical methods, higher order structure (HOS), colloidal stability, Quality by design (QbD), Critical Quality Attribute (CQA), dynamic and static light scattering methods, circular dichroism, fluorescence, differential scanning calorimetry (DSC), immunogenicity, impurities, excipients.


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PepTalk 2015

Strategies for Cross the Blood-Brain Barrier with Antibody Therapeutics

with Lois Lampson, Ph.D., Associate Professor of Surgery, Brigham and Women’s Hospital


Dr. Lois Lampson, an Associate Professor of Neurosurgery at Brigham and Women’s Hospital, describes novel ways of approaching the targeting of the brain (and brain cancers) using Antibody Therapeutics. Dr. Lampson is a speaker in the Cancer Targets for Antibody Therapeutics meeting being held at the 14th annual Peptalk on January 19-23, 2015 in San Diego.


Baculovirus-Insect Cell Systems for Protein Production

with Donald Jarvis, Ph.D., Professor, Molecular Biology, University of Wyoming; President, GlycoBac, LLC
and Dominic Esposito, Ph.D., Director, Protein Expression Laboratory, Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc.


Dr. Donald Jarvis of University of Wyoming and GlycoBac, LLC and Dr. Dominic Esposito of Frederick National Laboratory for Cancer Research, Leidos Biomedical Research, Inc. speak to CHI in November 2014. Drs. Jarvis and Esposito will be speakers during the Transient Protein Production conference at PepTalk, January 19-23, 2015 in San Diego, CA.

Topics include the benefits of protein processing in the baculovirus-insect cell system, future challenges for transient protein expression and production and possible solutions.


Enabling High-Throughout Protein Expression: Clones, Cell-Free Systems and Microarrays

with Joshua LaBaer, M.D., Ph.D., Director, Virginia G. Piper Center for Personalized Diagnostics and Virginia G. Piper Chair, Personalized Medicine, Biodesign Institute, Arizona State University


Dr. Joshua LaBaer of Arizona State University speaks to CHI on October 27, 2014. Dr. LaBaer will be a keynote speaker during the Recombinant Protein Expression and Production conference at PepTalk, January 19-23, 2015 in San Diego, CA.

Topics include applications of sequence-verified recombination-based clone sets to high-throughput protein expression, cell-free expression systems, sharing clones upon request for research, self-assembling protein microarrays and more.


CHO Cells and Computational Models for Recombinant Protein Expression

with Nathan E. Lewis, Ph.D., Assistant Professor, Novo Nordisk Foundation Center for Biosustainability, UCSD School of Medicine in San Diego


Dr. Nathan E. Lewis of the Novo Nordisk Foundation Center for Biosustainability at UCSD School of Medicine speaks to CHI on November 3, 2014. Dr. Lewis will be a speaker during the Recombinant Protein Expression and Production and CHO Cells conferences at PepTalk, January 19-23, 2015 in San Diego, CA.

Topics include the promise and challenges of using Chinese hamster ovary cells for enhancing recombinant protein expression and production, the creation of computational models by integrating metabolism glycosylation and the protein secretion pathway, the Novo Nordisk partnership with University of California, San Diego and more.


The Product Quality Research Institute (PQRI) and the Issue of Leachables and Extractables: Updates, Best Practices and Recommendations

with Daniel L. Norwood, M.S.P.H., Ph.D., Distinguished Research Fellow, Analytical Development, Boehringer Ingelheim Pharmaceuticals, Inc.


Nandini Kashyap interviews Dr. Daniel L. Norwood of Boehringer Ingelheim Pharmaceuticals on October 15, 2014. Dr. Norwood will be speaking during the 3rd Annual Extractables and Leachables conference which takes place on January 22-23 at the upcoming PepTalk event which runs from January 19th to 23rd, 2015 in San Diego, CA.

Topics Include: Extractable, Leachable, PQRI – PODP, United States Pharmacopeia, FDA, Parenteral and Ophthalmic Drug Products, Single use technologies, Risk assessment, Analytical Study design for E&L, Regulatory consideration, Toxicological considerations, Cell Culture, Plastic Packaging Systems, Pharmaceutical Packaging/Delivery Systems, multi-product facilities , Leachables in Large Volume Parenteral Products




Analytical Control Strategy for Novel Complex Recombinant Biotherapeutics: Begin with the End in Mind

with Johnson Varghese, Ph.D., Senior Director, Head of Analytical Development, Shire HGT


Nandini Kashyap interviews Dr. Johnson Varghese of Shire HGT on October 1, 2014. Dr. Varghese will be speaking during the Characterization of ADCs, Bispecifics and New Biotherapeutics conference taking place on January 19th-20th at the upcoming PepTalk event which runs from January 19th to 23rd, 2015 in San Diego, CA.

Topics include: Analytical control strategy, Quality by Design (QbD), analytical tools for biologics, recombinant non-mAb therapeutics, post-translational modifications, safety and efficacy of biologics, critical assessments of product attributes, early and late stage development for novel molecules, product life cycle management.




PepTalk 2014

Best Practices and Procedures to Ensure Patient Safety: Toxicological Risk Assessment of Extractables and Leachables

with William P. Beierschmitt, Ph.D., DABT, FATS, Regulatory Strategy Lead, Worldwide Research and Development Drug Safety Research & Development, Pfizer, Inc.


Nandini Kashyap interviews Dr. William P. Beierschmitt, Ph.D., DABT, FATS, Regulatory Strategy Lead at Pfizer on December 20, 2013. Dr. Beierschmitt will be speaking during the 2nd Annual Extractables and Leachable conference taking place January 16-17 as part of PepTalk, January 13-17 in Palm Springs, CA.

Topics include early adoption of toxicological risk assessment, risk assessment strategy, patient safety, safety issues related to extractables and leachables, role of toxicologist, plastic single use bioreactors, single use systems, risk based assessment, extractable testing, flexible manufacturing, process and product development, BPOG, USP, PQRI, standardized E&L testing, predication of leachable, toxicity and safety.




PepTalk 2013

Emerging Drying Technologies: Room Temperature Stable Flu Vaccine Formulation Using Spray Drying

with Jeffrey Breit, Ph.D., Director, Pharmaceutical, Bend Research


Nandini Kashyap interviews Jeffrey Breit, Ph.D of Bend Research on November 15, 2013. Dr. Breit will be speaking during the Lyophilization and Emerging Drying Technologies conference at the PepTalk, January 13-17 in Palm Springs, CA.

Topics include using a vaccine formulation development, room temperature stability, use of spray drying, emerging drying technologies




Unfolded Protein Response: Pathways to Recombinant Protein Production

with Zhimei Du, Ph.D., Senior Scientist, Cell Sciences & Technology, Amgen, Inc.


An-Dinh Nguyen interviews Zhimei Du of Amgen on November 1, 2013. Dr. Du will be speaking during the Recombinant Protein Expression and Production conference at PepTalk 2014, January 13-17 in Palm Springs, CA.

Topics include unfolded protein response, pathways for increasing recombinant protein production and expression yield, understanding cell status, UPR’s dynamic nature and cell line development at Amgen.




Cellular Biology, Biotechnology and Recombinant Protein Production

with Sabine Geisse, Ph.D., Director/NLS, Novartis Institutes for BioMedical Research


An-Dinh Nguyen interviews Sabine Geisse, Ph.D., Director/NLS, Novartis Institutes for BioMedical Research on October 31, 2013. Dr. Geisse will be a keynote speaker during the Transient Protein Production conference at PepTalk 2014, January 13-17 in Palm Springs, CA.

Topics include the importance of considering cellular environments when working on genes and molecular biology, the evolution of biotechnology, recombinant production of increasingly complex biomolecules and more.




Efficient Protein Expression and Engineered Bacteria

with Joseph Kittle, Jr., Ph.D., Assistant Professor, Chemistry and Biochemistry, Ohio University and CSO, Molecular Technologies Laboratories, LLC


An-Dinh Nguyen interviews Joseph Kittle of Ohio University and Molecular Technologies Laboratories, LLC on October 30, 2013. Dr. Kittle will be a speaker during the Engineering Genes, Vectors, Constructs and Clones conference at PepTalk 2014, January 13-17 in Palm Springs, CA.

Topics include problems with plasma-based protein expression, using engineered bacteria and chromosomally inserted genes, integrating current biotech industry knowledge with academic biochemistry and molecular engineering instruction and more.




Simplifying Genomics and Optimizing Protein Expression

with Curtis Knox, Vice President, Marketing & Sales, Lucigen Corp.


An-Dinh Nguyen interviews Curtis Knox of Lucigen on October 14, 2013. Mr. Knox will be a speaker during the Engineering Genes, Vectors, Constructs and Clones conference at PepTalk 2014, January 13-17 in Palm Springs, CA.

Topics include the challenges and advantages of endotoxin reduction in recombinant protein expression processes for drug discovery R&D, high-throughput cloning and expression of target proteins, large insert metagenomic libraries from soil microbes and more.




Protein Expression and Biological Engineering: Bacteria and Beyond

with Sriram Kosuri, Ph.D., Assistant Professor, Chemistry and Biochemistry, University of California, Los Angeles


An-Dinh Nguyen interviews Sriram Kosuri of UCLA on November 11, 2013. Dr. Kosuri will be a keynote speaker during the Engineering Genes, Vectors, Constructs and Clones conference at PepTalk 2014, January 13-17 in Palm Springs, CA.

Topics include the effect of codon usage on protein expression, the reliance on bacteria for biological engineering research, new tools like CRISPR for studying more eukaryotic systems, next-generation gene synthesis, work at the Wyss Institute and more.




Large Volume Injectors for Subcutaneous Delivery: Challenges and Future Perspectives

with William J. Lambert, Ph.D., Fellow, Drug Delivery, Device Development and Commercialization, MedImmune, Inc.


Nandini Kashyap interviews Dr. William J. Lambert of MedImmune on December 6, 2013. Dr. Lambert will be speaking during the 4th Annual Protein Device Combinations conference taking place Jan 15-16, 2014 as part of PepTalk, January 13-17 in Palm Springs, CA.

Protein Delivery, large volume delivery, bolus injections, delivery devices such as pens and auto injectors for drug delivery, high viscosity injectors, protein device combinations, protein and peptide products, pen injectors, pen needles and auto-injectors for self-injection, integration of formation and devices.




Protein Aggregation and Emerging Tools: Mechanism, Challenges, and Future Perspectives

with Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire


Nandini Kashyap interviews Prof. Thomas Laue of University of New Hampshire on November 19, 2013. Prof. Laue will be speaking during the Protein Aggregation and Emerging Analytical Tools conference at the PepTalk, January 13-17 in Palm Springs, CA.

Topics include protein aggregation, mechanism of protein aggregation, non-covalent interactions, hydrophobic effect, dipole-dipole interactions, effect of viscosity, development of analytical tools for aggregate detection, progress in the field of protein aggregation.




Amgen’s Case Study on Extractables from Single-Use Bioreactors and Impact on Cell Culture Performance

with Yasser Nashed-Samuel, Ph.D., Principal Scientist, Process and Product Development, Amgen, Inc.


Nandini Kashyap interviews Dr. Yasser Nashed-Samuel, Principal Scientist, Amgen on December 6, 2013. Dr. Yasser Nashed-Samuel will be speaking during the 2nd Annual Extractables and Leachable conference taking place Jan16-17 as part of PepTalk, January 13-17 in Palm Springs, CA.

Topics include a case study on E&L from single use bioreactors, E&L impact on cell culture performance, plastic single use bioreactors, single use systems, risk based assessment, extractable testing, flexible manufacturing, process and product development, , BPOG, USP, PQRI, standardized E&L testing, predication of leachable, toxicity and safety.




Process Analytical Technologies for Freezing and Primary Drying of Biologics

with T.N. Thompson, President, Millrock Technology, Inc.


Nandini Kashyap interviews T.N. Thompson, President, Millrock Technology on December 6, 2013. Mr. Thompson will be speaking during the 7th Annual Lyophilization and Emerging Drying Technologies conference taking place Jan15-16 as part of PepTalk, January 13-17 in Palm Springs, CA.

Topics include freeze drying, process control and monitoring for the freezing and primary drying phases, cycle development and process control, controlled nucleation, heat flow, reduction in drying cycle’s time.




BPOG’s Extractable Protocol Standardization Journey: Update on E&L Collaboration Efforts Between BPOG and Major Industry Groups

with Ken Wong, Ph.D., Deputy Director, MTech, Sanofi Pasteur


Mimi Langley interviews Ken Wong, Ph.D., Deputy Director, MTech of Sanofi Pasteur on November 22, 2013. Dr. Wong will be speaking during the Single-Use Technologies & Continuous Processing in Biopharm Manufacturing conference at PepTalk, January 13-17 in Palm Springs, CA.

Topics include what are the current challenges on E&L, how are industry groups collaborating on this issue, and what are BPOG’s (Biophorum Operations Group) initiatives and efforts on standardization protocol.


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