BEBPA provides an international forum for the presentation and discussion of scientific issues and problems encountered in the biopharmaceutical community. The aim of this open discussion is to promote development of innovative approaches and solutions thus facilitating safer and faster biopharmaceutical product development.
Dr. Alexey Khrenov received his Ph.D. in Biochemistry from the Institute of Biochemical Physics of Russian Academy of Sciences in Moscow, Russia and is currently CMC reviewer in the Division of Plasma Protein Therapeutics (DPPT), in the Office of Tissues and Advanced Therapies (OTAT) in CBER/ FDA. His review responsibilities include review of CMC sections of marketing and investigational applications and supplements for plasma-derived and recombinant hemostatic products. Dr. Khrenov also participated in multiple pre-license and surveillance inspections of manufacturing facilities. Prior to joining the FDA Dr. Khrenov worked at the American Red Cross Holland Laboratory, United States Pharmacopeia and National Institutes of Health. He has been with the FDA for 5 years.
2020 PRESENTATION TITLE:
Control of Host Cell Proteins throughout Product Lifecycle
Wednesday, 23 September 2020, 14:45 CET
Day 1: Regulatory Trends Session
See full abstract HERE.
Andreas Zerr is a Lead Scientist in the Forensic Chemistry group at Lonza’s Drug Product Services in Basel, Switzerland, specialized in surfactant analytics in biological drug substance and drug product. During his previous 8 years in industry (Celerion and Novartis), Andreas was performing method development for specialized trace analytical methods and structure elucidation.
During his 4 years at Lonza, he was planning and executing development studies for surfactant quantification methods, which were used later in a controlled QC environment. In addition, he was also performing investigational studies related to surfactants.
In his current position, Andreas is using his extensive analytical knowledge on the topic of surfactants to support Lonza’s customers from the (Bio )Pharmaceutical Industry.
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2020 PRESENTATION TITLE:
Measuring Lipolytic Activity to Support Process Improvements to Manage Lipase-Mediated Polysorbate Degradation
Tuesday, 27 October 2020, 16:35 CET
Day 2: ID/Management of ID’d HCP’s Session
See full abstract HERE.
Cullen Mason is a Senior Scientist and group leader in the Analytical Development department at Biogen. She is responsible for the development and qualification of host cell protein impurity assays and cell-based potency assay that support the pre-clinical and clinical development of biologics and gene therapy programs. Prior to Biogen, she was a scientist at The Scripps Research Institute and she received her Ph.D. in neuroscience from The Ohio State University.
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2020 PRESENTATION TITLE:
Transitioning a Late Stage Gene Therapy Program from a Commercial Kit to a Platform, In-House Immunoassay
Tuesday, 27 October 2020, 18:50 CET
Day 2: Gene Therapy Session
See full abstract HERE.
Rikke Raaen Lund is Head of the Impurity Analysis team at Alphalyse. She has lead more than 100 projects on Host Cell Protein analysis by LC-MS of different biologics, including mAbs, vaccines, cell and gene therapy products. Rikke is co-developer of the new ELISA-MS coverage method, presented at BEBPA 2019. This method provides high resolution HCP coverage analysis by combining ELISA immunocapture directly with LC-MS. Rikke Raaen Lund has a background in medical protein research with a PhD in Cancer Proteomics from Institute of Molecular Medicine, University of Southern Denmark.
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2020 PRESENTATION TITLE:
HCP Profiling in Commercial mAbs and Biosimilars
Tuesday, 27 October 2020, 15:20 CET
Day 2: ID/Management of ID’d HCP’s Session
See full abstract HERE.
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RECENT PUBLICATION:
(You heard it first at BEBPA’s 2019 HCP Conference!)
A novel approach to evaluate ELISA antibody coverage of host cell proteins—combining ELISA‐based immunocapture and mass spectrometry
Read the full publication HERE.
Dr. Lars Skriver is Senior Science Officer at SAVARA with responsibility for company cross functional science activities including development and implementation of new technologies in drug characterization.
Prior to joining SAVARA, Lars has for 12 years been consultant in biotech product development from gene to commercial.
Furthermore, Lars has served in biotech product development functions at Novo Nordisk DK for > 12 years
Research activities include lipid and protein chemistry combined in functional membrane biochemistry and cancer metastasis.
Lars has an M.S. in Biology and Ph.D. in Biochemistry from the University of Copenhagen.
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2020 PRESENTATION TITLE:
Improving Product Quality and Enabling Patient Risk Assessment by LC-MS/MS Analysis of Host Cell Proteins in Inhalation Products
Tuesday, 27 October 2020, 15:45 CET
Day 2: ID/Management of ID’d HCP’s Session
See full abstract HERE.
Dr. McCarthy is a Senior Manager in USP’s Global Biologics Department. Diane leads a team that focuses on development of new standards that can help address bottlenecks in the biotechnology industry. Prior to joining USP, Dr. McCarthy was Senior Scientific Director at Caprion Biosciences, where she focused on the use of mass spectrometry for characterization of biologics and host cell proteins. Her previous roles also included Director of Scientific Affairs at Ezose Sciences, where she focused on identification and quantitation of glycans by mass spectrometry and Global Manager, Biomarker Research Center, at Bio-Rad Laboratories, where she directed translational and biomarker research contracts and collaborations with industry, key consortia, academic, and government groups.
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2020 PRESENTATION TITLE:
USP Standards to Support Host Cell Protein Analysis
Monday, 26 October 2020, 18:20 CET
Day 1: Regulatory Trends Session
See full abstract HERE.
Veronika Reisinger works currently in the physico-chemical characterization group at Novartis Global Drug Development in Austria as laboratory head. Before joining Sandoz in 2011 as scientist in the characterization group, Veronika worked as a postdoctoral fellow in a protein biochemistry laboratory at the University of Stavanger, Norway. Her current work focuses on the mass spectrometric characterization of biopharmaceuticals and associated impurities..
2020 PRESENTATION TITLE:
Development and Qualification of an Absolute Quantification Workflow for an Immunogenic HCP
Tuesday, 27 October 2020, 16:10 CET
Day 2: ID/Management of ID’d HCP’s Session
See full abstract HERE.
Lake obtained his PhD in Structural Biology and Biophysics from Purdue University under Cynthia Staffaucher. After his PhD, he joined a Mass Spectrometric-focused lab at NIEHS for his postdoctoral studies. After his post-doctoral studies, he created the Biophysical Analysis Lab at the Bindley Bioscience Center where he introduced a comprehensive and successful biophysics analytical program that included AUC, CD, ITC, DLS, DSC, SPR, BLI and MALLS techniques. He was also the Director of the Purdue Proteomics Facility, where he implemented new analytical methods for looking at large proteomic data, PTMs, de novo sequencing and quantitation (MRM/SRM, LFQ and isotopic labeling).
Lake went into the industrial sector where he led programs that focused on discovery, process development, cGMP method development and validation, cGMP manufacturing and Quality Control for a variety of systems: Small Molecules, Proteins, mAbs, ADCs to Gene Therapy. Lake started his own CRO/Consulting company: BioAnalysis, LLC, focusing on high level biophysical and analytical chemistry collaborations. His deep expertise: >25 peer-reviewed publications, business acumen, CMC strategy, BLA/MAA submissions, QA/C and analytical method development/validation has proven to be an invaluable resource to his clients
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2020 PRESENTATION TITLE:
Combinatorial HCP Analysis and Characterization using LC-MS/MS-MS: Gene Therapy
Tuesday, 27 October 2020, 18:10 CET
Day 2: Gene Therapy Session
See full abstract HERE.
Margaret Lin is a Manager in the Analytical Development & Quality Control group at Genentech where she works on host cell proteins and other process related impurities starting from assay development and supporting through clinical GMP lot release. She is a lead project manager establishing relationships with outside partner groups and CMOs for analytical testing. Margaret has 15 years of industry experience, working in a variety of fields including manufacturing, process virology and potency assay development..
2020 PRESENTATION TITLE:
Case Study: Using Our HCP Analysis Suite to Select the Most Appropriate ELISA for a Late Stage Program
Monday, 26 October 2020, 16:10 CET
Day 1: Assay and Reagent Development Session
See full abstract HERE.
Pia Paarmann studied Biochemistry at the ‘Freie Universität’ of Berlin. After finishing her Diploma Thesis at the Max Delbrück Center for Molecular Medicine, she started her PhD at the Institute of Biochemistry, also at the ‘Freie Universität’ of Berlin. In her thesis, she focused on the signal transduction pathways of Bone Morphogenetic Proteins and their regulation by endocytic processes. Pia joined BioGenes in 2016 as a Project Manager for antibody and immunoassay development and became head of the 2D analytics department in 2017. Pia has a strong focus on HCPs and uses the 2D electrophoresis technique for comprehensive HCP sample and antibody reagent characterization..
2020 PRESENTATION TITLE:
Case Study – Comparison of Orthogonal Methods for Reliable HCP Coverage Determination
Monday, 26 October 2020, 15:45 CET
Day 1: Assay and Reagent Development Session
See full abstract HERE.
Michael’s career has focused on bioprocess and analytical research, development, scale-up and cGMP manufacturing of biotherapeutics for the last 33 years.
He started his career at Hoffman LaRoche from 1987-89 in bioprocess development before joining University of Nebraska-Lincoln (UNL) in 1989. Over the next 22 years, he worked with DoD on process research, development and scale-up vaccines against bioterrorism agents, such as botulism, ricin and anthrax, and he oversaw the building of UNL’s Biological Process Development Facility (BPDF) from the ground up, a facility which includes an 11,000 ft2 cGMP facility dedicated to producing recombinant biotherapeutics for Phase I and II clinical trials. The BPDF covered all aspects of process development from molecular biology, fermentation, purification, analytical methods to quality control and cGMP manufacturing. During his tenure at UNL, the BPDF had received over $57 million in funding.
In 2011, he joined St. Jude Children’s Research Hospital (St. Jude) as President of Children’s GMP LLC, Vice President of Therapeutics Production and Quality, and a full member at St. Jude. The St. Jude GMP Building, is a 64,000 ft2 facility with 52 full time staff, responsible for process development and cGMP manufacturing of Drug Products for Phase I and II clinical studies at St. Jude. Products include cellular and gene therapy products, including Chimeric Antigen Receptor T cells (CAR-T), genetically modified hemopoietic stem cells (CD34+) for treatment of X-SCID, adeno-associated viruses (AAV) for treatment of hemophilia A and B, lentiviruses, live virus vaccines, monoclonal antibodies and recombinant proteins
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2020 PRESENTATION TITLE:
Residual Analysis of cGMP Adeno-Associated Virus and Lentivirus for Human Gene Therapy
Tuesday, 27 October 2020, 18:20 CET
Day 2: Gene Therapy Session
See full abstract HERE.
