SC4: Surfactants in Biotherapeutics: Can’t Live with Them, Can’t Live without Them
MONDAY, 18 NOVEMBER | MORNING 9:00 - 12:00
ABOUT THIS COURSE: Surfactants are excipients critical to the stability of most biopharmaceutical parenteral formulations. They stabilize proteins in solutions by mitigating potential adsorption and interfacial stress-induced aggregation
or precipitation encountered during many stages of production, shipment and use. The most commonly used surfactants are the non-ionic excipients, Polysorbate 20 and 80. However, the use of these surfactants can also lead to a number of liabilities
related to stability (of the surfactant and of the active protein) as well as potential for pseudoallergenic reactions. Regulatory authorities are therefore also paying increasing attention to this critical excipient. This workshop will provide a
complete perspective on the use and control of polysorbates in biotherapeutic products.
WHAT YOU WILL LEARN:
- Mechanisms of protein stabilization by surfactants
- Formulating stable products with surfactants
- Mechanisms of polysorbate degradation
- Analytical methods to control and monitor polysorbate
- Consequences of polysorbate degradation and loss
- Control strategy for polysorbates
MEET THE INSTRUCTOR:
Atanas
Koulov, PhD, Head, Drug Product Analytical Development and Quality Control, Drug Product Services, Lonza Pharma and Biotech
Dr Atanas Koulov is the Head of Analytical development and Quality Control in the Drug Product Services group at Lonza Pharma and Biotech. Atanas has extensive experience in drug product analytical development and quality control release and stability
testing, as well as characterization, investigations support and specification setting. His more than eight years of industry experience include managing Roche’s Particle lab, activities for visible, subvisible and submicron particles as well
as responsibility for various programs in Analytical Development & QC of Drug Products. Prior to joining Roche, Atanas also worked as a Lab Head, Analytical Development at Novartis Biologics. Atanas has published extensively in the field of protein
aggregation and particles and is the immediate past chair of the AAPS Protein Aggregation & Biological Consequences Focus Group. Atanas holds a PhD in Biochemistry from the University of Notre Dame, IN (USA), earned his M.Sc. in Molecular Biology
and Clinical Chemistry from Sofia University (BG) and worked as Postdoctoral Fellow at the Scripps Research Institute in San Diego, CA (USA).
Hanns-Christian Mahler, PhD, Head, Drug Product Services, Lonza Pharma and Biotech
Dr. Mahler heads the Drug Product Services organization at Lonza since Sept.2015, building it up as a leading service provider for the Pharma and Biotech industry. His highly skilled and experienced team, based in Basel, provides formulation, manufacture
and analytical services with current focus on parenteral dosage forms for a variety of modalities such as biologics, drug conjugates, peptides and small molecules. Prior to this position, he led the Department of Pharmaceutical Development & Supplies,
Biologics EU at Roche, Basel, from 2010 to 2015 and as Head of Formulation R&D Biologics, Roche, Basel, from 2005 to 2010. Prior to Roche, Dr. Mahler worked at Merck KGaA, Darmstadt, Germany as Principal Formulation Scientist, Lab Manager for
Protein Formulation Development and Clinical Trial Manufacturing and CMC Team leader for Erbitux during its submission and launch phase. Dr. Mahler studied Pharmacy at the University of Mainz, Germany, holds in PhD in Toxicology from the Institute
of Pharmacy, University of Mainz and Pharmacist specialization degrees in Toxicology, Ecology and Pharmaceutical Technology. He obtained his venia legendi (German Habilitation) from the University of Frankfurt in 2010 and is Adjunct faculty and lecturer
at the Universities of Frankfurt (Germany), and Basel (Switzerland). He was elected an AAPS Fellow in November 2013 and nominated extraordinary Professor for Pharmaceutical Technology in November 2015. His work experience includes early- and late-stage/commercial
and line extension formulation development, primary packaging and device development, drug delivery, drug product process development, process characterization and validation, transfer to clinical and commercial drug product production and production
support and preclinical and clinical (phase 1-3) drug product GMP manufacturing of parenteral dosage forms of biologics, small molecules, peptides and oligonucleotides.
Satish
K. Singh, PhD, Head, Sterile Product Technology, Moderna Therapeutics Inc
Dr. Satish Singh is Head of Sterile Product Technology at Moderna Therapeutics Inc. Previously, he was the Head of Drug Product Process Development, in the Drug Product Services group at Lonza Pharma and Biotech, where he is leading the drug process development
and characterization capabilities. Prior to joining Lonza in Sept 2016, Satish was Research Fellow and Group Leader at Pfizer’s Biotherapeutics Pharmaceutical R&D unit. Satish has more than 25 years’ experience in the industry in product
development activities and is an internationally recognized expert in all aspects of (bio)pharmaceutical Drug Product (biologics, vaccines) development. His experience includes ophthalmics and parenterals, encompassing primarily biologics but also
small molecules, and he has been involved in the submission of several BLAs and INDs. Satish has a strong technical background, complemented by a deep understanding of regulatory challenges and the evolving regulatory landscape, and has more than
70 scientific publications in the field. He is involved in various professional groups through the American Association of Pharmaceutical Scientists (AAPS) as well as the USP and was a member of the expert panel that wrote USP <787> and <1787>,
and currently serves on the USP <771> Ophthalmic Preparations and USP <788> Subvisible Particles panel. His research interests also include the investigation of impact of freezing processes on proteins, use of computational approaches to
mitigate develop-ability issues, and aggregation and immunogenicity. He obtained his B.Tech from the Indian Institute of Technology, New Delhi, and an M.S. and Ph.D. in Chemical Engineering from Kansas State University. He holds the position of Adjunct
Professor at the Dept. of Physical Pharmaceutical Chemistry at Uppsala University, Sweden and was recently elected as Fellow by the AAPS.