• Evénements
  • Webinar
    • Bioprocessing Solutions
      • Risk mitigation and process debottlenecking in continuous biomanufacturing
      • Viral Clearance breakthrough: Enhancing efficacy and protein stability with a regulatory compliant, novel detergent
      • A novel cell lysis solution with advantageous use characteristics for rAAV manufacturing that can lead to greater downstream recovery by minimizing upstream loss
      • Detergent-based viral inactivation: a case study demonstrating enhanced monoclonal antibody purification
      • Advancing next gen biologic manufacturing by implementing continuous downstream processing platform
      • Adopting novel technologies to improve monoclonal antibody processes
      • Novel approach to purification and viral inactivation of new class of mAbs
      • Increased Downstream Efficiency of mAbs through use of Novel Purification Resin and Additives
      • Efficient raw material management for improving bioprocess throughput and flexibility
      • A Changing Landscape for Biopharma
      • Use of a Novel Cell Lysis Buffer for Protection of AAVs and Enhancing Manufacturing Efficiency
      • Understanding monoclonal antibody aggregate behaviour impacting chromatographic process efficiency
      • Improved antibody purification process through use of additives
      • Novel Purification Technologies and Approaches to Maximize Speed, Efficiency and Process Optimization
      • Solutions to optimize biopharma downstream processing
      • Solutions to manage complexity in global single-use supply chain for vaccines manufacturing
      • Process debottlenecking in buffer and media prep using enhanced raw material release/delivery strategies
      • Downstream Process Intensification with Novel Chromatography Resins for Enhanced Monoclonal Antibody Purification
      • Digitalizing biopharma
      • Understanding the critical roles of cGMP chemicals and single-use technologies in cell & gene therapy manufacturing
      • Novel Single-use Solutions for Cell & Gene Therapy Manufacturing
      • Innovative direct dispense technology to ensure in-time delivery and release during continuous biomanufacturing
      • Designing Novel Fluid Sampling Systems for GMP Operations
      • Faster, better, together: Biopharma collaboration trends in the pandemic, and the future of medicine
      • A collaborative ecosystem: Accelerating the commercial manufacturing of novel vaccines and other therapeutics
      • Advancing Adeno-Associated Virus (AAV) Characterization: High-Resolution Techniques for Gene Therapy Applications
    • Chromatography
    • Equipment & instruments
    • Chemicals
    • Quality Control
    • Safety
    • Life Science
    • Controlled Environment

Higher titers in monoclonal antibody processes and newer cell & gene therapy products have introduced various new technologies into the biopharma market. While these new technologies have furthered the field as a whole they have also generated several new challenges in raw material management from a regulatory, quality and supply chain standpoint. The manufacturing process innovation that leads to increase in flexibility while decreasing overall drug product cost can help meeting some of the market challenges. A lot of progress has been made to improve upstream to downstream unit operations.

However, many challenges need to overcome to implement well-functioning fully integrated continuous manufacturing. Typical biologic manufacturing consumes hundreds of raw materials including media, supplements, process chemicals, filters, resins, and excipients. Managing the flow of these components and releasing them on a timely basis is a daunting task without either increasing inventory levels or implementing a non-traditional approach to receive release. Using these materials while meeting all quality and regulatory requirements and predicting process variations are key to de-risking the manufacturing process.

In this presentation we will present some case studies of issues in raw material management and discuss various options with risk and benefit analysis to overcome some of these challenges.

This presentation was given during BPI Boston, September 28, 2022.

Presented by:

Dr. Pranav Vengsarkar, Manager, Research & Development – Biopharma Production Pranav Vengsarkar, Ph.D., is Manager, Process Development at Avantor, focused on product and process development for new cGMP products and excipients, and development and design of single-use raw material delivery systems. Pranav holds a Bachelor of Chemical Engineering degree from ICT, Mumbai and a Ph.D. in Chemical Engineering from Auburn University.