During BioProcessing International, Boston (September 9-12, 2019) , connect with Intertek to explore how we can help you to achieve your biopharmaceutical development goals.
BioProcess International (BPI) 2019 connects those working across the entire spectrum of biopharmaceutical development and production. Our experts will be attending BPI, September 9-12 in Boston so contact us now to arrange a meeting during the event or visit exhibition stand 1213 to discuss how our expertise can help you meet your development program milestones. Anshuman Shukla, our Biophysical Expert will be presenting on regulatory consideration for biophysical characterisation.
BIOPROCESSING INTERNATIONAL PRESENTATION
Current Analytical Approaches to Biophysical Characterization in a Regulatory Environment
Thursday 12th September, 2019, 11.35am
Anshuman Shukla, Biophysical Expert, Intertek Pharmaceutical Services
Abstract: Structural integrity of protein based therapeutics is one of the major challenges in the biopharmaceutical industry where multiple factors such as the stability, efficacy and shelf life could be affected following minor changes in manufacturing process. Multiple Biophysical methods employing spectroscopic and calorimetric tools can be used for analysing Higher Order Structure (HOS). Moreover, with an increasing demand for generating as much structural information as possible for regulatory submissions, a requirement for these analyses in a GMP set up is also important. This presentation from Intertek’s biophysical expert, Anshuman Shukla, details different biophysical techniques, their application and usefulness in a regulatory set up.
OUR SERVICES
Our protein characterisation services are developed in accordance with the ICH Q6B Guidance to ensure the quality and consistency of your biologic. Protein structure analysis, physiochemical property determination, biological and potency assays, product-and process-related impurity testing, are delivered from our team located in Manchester, UK. Our capabilities are focused on support for your product development, in-process testing, identity confirmation, comparability, stability and batch release testing. We are experienced in developing and validating assays for bioanalytical pharmacokinetic (PK), toxicokinetic (TK), immunogenicity, and biomarker studies supporting early discovery through to late stage clinical studies.
RESOURCES
Webinar: New Strategies for Optimizing Biologic Formulations
Article: Monoclonal Antibody Structural Characterization Challenges
Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards for biotech innovation. Our thought-leaders have over 20 years’ experience in biopharmaceutical development support across a wide range of product types including proteins, monoclonal antibodies, vaccines, viral vectors and advanced delivery systems, PEGylated complex molecules, antibody drug conjugates, peptides, oligonucleotides and biosimilars. With broad capabilities in Europe and North America we help you meet and exceed your quality, safety and efficacy requirements. Our experts provide strong scientific and technical leadership coupled with project management and regulatory support, to drive your development programs forward.
