Meet with Intertek during Biotech Week Boston 2019
Connect with Intertek during Biotech Week Boston (BWB), September 9-12, 2019 and explore how we can help you achieve your biopharmaceutical development goals.
Biotech Week Boston includes a series of leading events spanning the drug development value chain, providing access to the most inventive scientific minds and business leaders from Boston and around the world. During BWB. Intertek experts will be presenting at both the BioProcessing International Conference and the Cell and Gene BioProcessing Conference highlighting the latest analytical approaches in biopharmaceutical development. Contact us now to arrange a meeting during the event or visit Booth #1213 in the exhibit hall to discuss how our expertise can help you meet your development program milestones.
PRESENTATIONS DURING BIOTECH WEEK BOSTON
If you would like a copy of these presentations, please send a request now to receive the slides after the event.
BIOPROCESSING INTERNATIONAL PRESENTATION
Current Analytical Approaches to Biophysical Characterization in a Regulatory Environment
Thursday, September,12, 2019, 11.35AM
Anshuman Shukla, Biophysical Expert, Intertek Pharmaceutical Services,
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.
CELL & GENE BIOPROCESSING PRESENTATION
Advanced Analytical Approaches to Viral Vector Characterization
Tuesday, 10th September 2019, 2.10PM
Mark Redfern, Project Manager - Cell and Gene Therapies - Characterization, Stability and Release Testing, Intertek Pharmaceutical Services
As the cell and gene therapy field continues to evolve and products enter clinical development, the need for appropriate analytical tools is critical to achieving well-characterized products, this includes a requirement to ensure quality control of the delivery system as well as the drug substance. Robust analytical technologies which can drive insight into critical quality attributes can ensure a better understanding and control during the manufacturing process. This presentation describes a range of techniques you can apply to characterization and quality control testing for viral vectors, such as AAVs, and key considerations for deploying these approaches to monitor quality attributes, ensuring a safe, high quality, consistent and efficacious product.
Article: Bispecific Antibody Characterization
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.
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