Waterfront 1C


Impurities in Protein therapeutics can originate from a variety of unexpected sources. As the protein molecule is taken through the upstream/downstream processes, final product manufacturing (fill/finish) and even during patient delivery, there are a myriad of potential "hidden" impurities that can have an impact to the safety and efficacy of the bio-therapeutic. This course aims to answer the questions of what and where are the greatest risks for biologic impurities and how can we study the impact of these impurities on the protein molecule. Our mission is to collectively discuss how to identify, evaluate and mitigate impurity risks from early development and throughout the product life cycle.


  • Overview of Biologic Impurities
    • Regulations, Guidelines and Risk Identification Strategies
  • Sources of Impurities:
    • Raw materials, Cell culture or fermentation media, fermenters or bioreactors, single-use systems
    • Buffers, excipients, surfactants
    • Purification skids, filling lines, container/closure systems, pre-filled syringes
  • Analysis of Impurities and Stability Assessment
    • QbD, Study Designs, Model proteins
    • Analytical Technologies and Data Assessment
      • Raw Material Characterization
      • Where to start: what chemical entities to use to stress the protein
      • Protein stability assessment using biochemical and biophysical toolbox (SEC, icIEF, CE-SDS, spectroscopy (CD, Fl), calorimetry (DSC), light scattering (DLS, MALS)); elemental quantitation (ICP-MS)
  • Control of impurities and Lifecycle Manamgment
    • Identifying risks in early development phases
    • Expose the target molecule to the most likely impurities that it will come into contact based upon the manufacturing design; determine the impact on stability
    • Qualifying Components Mitigation Strategies


  • To interact with fellow scientists who share a common concern for the impact of impurities and leachables on the long-term stability and safety of biologics
  • To learn about the most common sources of chemical impurities in biologics throughout the product lifecycle, control and mitigation strategies
  • To participate in discussions centered around the design of studies to investigate the effect of impurities and leachables on protein stability
  • To learn more about the protein stability toolbox and how these assays can detect changes to protein structure and stability upon exposure to common chemical impurities


Protein design scientists, formulation scientists, quality assurance, regulatory affairs, manufacturing engineers and process design scientists, study directors, manufacturers of storage systems, delivery devices, single-use equipment


Bowers_KatherineKatherine E. Bowers, PhD, Principal Scientist, Group Leader, Fujifilm Diosynth Biotechnologies

Katherine Bowers received her B.S. in Chemistry from Shepherd University in Shepherdstown WV, followed by her PhD in Chemistry at the Pennsylvania State University. Her graduate research, under the direction of Dr. Robert Matthews, focused on studying the protein folding mechanisms of E. coli DHFR and the -subunit of tryptophan synthase, using a protein fragmentation approach coupled to biophysical techniques to search for independent folding domains. Katherine Bowers then conducted Postdoctoral training in mechanistic enzymology at the University of Michigan, Department of Chemistry, under the direction of Dr. Carol Fierke. This research involved probing the chemical mechanism of mammalian farnesyltranferase, an enzyme involved in the post-translation lipidation of key signaling proteins, using site-directed mutagenesis, transient kinetics and kinetic isotope effects. After Postdoctoral training, Katherine Bowers worked as a Formulation Development Scientist at Regeneron Pharmaceuticals in Tarrytown NY. Katherine Bowers is currently employed at Fujifilm Diosynth Biotechnologies as a Formulation and Analytical Development Scientist for this contract manufacturer of protein-based therapeutics. In this role, Dr. Bowers works with a wide variety of protein molecules, using biophysical techniques to support manufacturing process development and the development of stable parenteral formulations.

Paskiet_DianeDiane Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc.

Diane Paskiet has over twenty-five years of experience with qualification of packaging and delivery systems for use with pharmaceutical products. Her background is in analytical chemistry and regulatory affairs and she has served as a project advisor in support of regulatory filings associated with drug product delivery systems. She is currently Director of Scientific Affairs at West Pharmaceutical Services where she is involved with advancing scientific collaborations related to suitability of packaging components and delivery systems. Prior to this role she oversaw site operations for West-Monarch Analytical Laboratories. She is a co-recipient of the United States Pharmacopeia (USP) award for Innovative Response to a Public Health Challenge and 2019 Vice Chair of Packaging Storage and Distribution Committee. She also serves as Chair of Product Quality Research Institute (PQRI) Development Technical Committee (DTC) and Chair of Parenteral and Ophthalmic Drug Product Leachables and Extractables Working Group. Ms. Paskiet is also on the faculty of the Parenteral Drug Association Training Institute and author/co-author of papers related to pharmaceutical packaging and delivery systems.