Downloads

1. The Clinical Trials Conundrum With Allan Shaw 10/17/2021

   The clinical trials status quo is a roadblock. They're slow, they're inefficient, and they're expensive. On this episode of the Business of Biotech, friend and frequent guest Allan Shaw shares some strong opinions on what's wrong with clinical trials, and what the industry (read: you) and the FDA need to do to make them right. 

2. 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.

3. 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.

4. BridgeBio's Approach To Gene Therapy & Nearing The Clinic With Dr. Eric David 10/13/2021

   BridgeBio's CEO of Gene Therapy, Dr. Eric David, explains the company's gene therapy programs for Canavan disease and congenital adrenal hyperplasia, their manufacturing plans, and the platform underpinning their approach to gene therapy.

5. AltruBio's Gene Lee, Ph.D. On CMC Developability Assessments 10/10/2021

   AltruBio VP of Technical Development, Gene Lee, Ph.D., joins the Business of Biotech for a deep dive into the importance of CMC developability assessments, covering the key points they must address, when to begin them, how to go about them efficiently, and why they're integral to early milestones and rapid entry into Phase 1 clinical trials.

6. Improve CMC Productivity Through Digital Lab Transformation 10/6/2021

   Speeding innovative and successful new drugs to patients will require the end-to-end, digital transformation of CMC processes. Explore how “always-on,” digital lab informatics services can improve collaborative innovation and productivity across your global CMC organization.

7. Reduce Protein Biologic Development Risk 10/6/2021

   Potency assays are an important part of the drug development process and are required throughout the lifetime of the product. Explore the process of assay development, qualification, and validation for critical potency assays and how Sartorius supports customers through this vital step.

8. 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.

9. Cell Line Development: Accelerating Antibody Discovery With The Octet® Platform 10/5/2021

   Cell line development involves multiple processes. Large numbers of clones are screened and selected on the basis of productivity and stability. An established platform for rapid titer of antibody clones can enable quick selection of high-producing clones.

10. 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.