Bioprocessing White Papers

1. Quality by Design (QbD) for Adeno-Associated Virus (AAV) 10/14/2021

   Chemistry Manufacturing and Controls (CMC) for gene therapies is one of the biggest obstacles when moving towards regulatory approval and presents a significant risk to the success of new gene therapy drug candidates today. Here we review a framework for a QbD assessment for AAV products within the Chemistry Manufacturing and Controls (CMC) documentation.

2. Local Treatment Of Non-Small Cell Lung Cancer With A Spray-Dried Bevacizumab Formulation 10/14/2021

   Local delivery of biotherapeutics to the lung holds great promise for treatment of lung diseases, but development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

3. Envisioning The Future Of Analytical Development For Gene Therapies 10/13/2021

   Explores how safety and characterization testing of viral vector production differs from that of other biologics and how novel analytical approaches are being tailored to these advanced therapeutics.

4. Implementation Of Rapid Test Methods In Cell And Gene Therapy Testing 10/12/2021

   Rapid testing methods for sterility, mycoplasma, and replication competent lentivirus of cell and gene therapies can help address critical issues within this rapidly growing area of the market.

5. A Multifaceted Strategy For Viral Safety In AAV Processes 10/7/2021

   Assurance of viral clearance can be difficult, however, during production of vectors such as adeno-associated viruses (AAV) used for the purpose of gene delivery. The need to define and deploy an appropriate and robust viral clearance strategy can be particularly challenging without an overarching strategy in place.

6. Protecting Protein Stability With A Novel Grade Of Sucrose 10/6/2021

   Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection. This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.

7. Analytical Power Tools Open Upstream Bioprocessing Bottlenecks 10/5/2021

   Clone selection is a significant upstream bottleneck slowing bench-to-bedside development progress for new mAbbased therapeutics. With mAb-based product development addressing diseases of such massive financial and societal implications, researchers using analytical power tools can reach their goals faster and shorten the bench-to-bedside development path, benefitting both patients and the bottom line.

8. Secure The Cell Therapy Supply Chain From Bench To Bedside 10/4/2021

   While current approaches can manage the existing volume of cell therapy shipments, scaling these treatments up and out will increase pressure on cryogenic logistics networks. Here, we consider the challenges and risks associated with the cell therapy cryogenic supply chain and provide considerations for mitigation strategies.

9. Viral Vector Vaccine Bioprocessing Handbook 9/21/2021

   Vectored vaccines show promise in their reliability to induce potent cell-mediated immunity. This paper describes a template to manufacture an adenovirus-based vaccine.

10. Virus-Based Vaccine Bioprocessing Handbook 9/21/2021

    The manufacturing process for each viral vaccine is dictated by shape, size, nature, physico-chemical behavior, stability, and host specificity. This paper reviews steps in these manufacturing processes.