Industry Insights

  1. Plasmid DNA Manufacturing To See Impressive Growth In Years Ahead 5/30/2023

    Plasmid DNA is surging as an ideal starting material for gene therapies and vaccine production. Using new market research, let’s look at key market drivers, vital roadblocks, regional analysis, and the leading players in the space.

  2. De-Risking Cell And Gene Therapy Clinical Trials 5/25/2023

    Ohio State University Gene Therapy Institute's Dr. Russell Lonser explains five major reasons for the early failures in direct delivery gene therapy trials, methods and technologies to increase the efficacy of direct drug delivery, and more.

  3. The 2 Factors Driving A Surge In Aptamer Use In Drug Discovery 5/25/2023

    Aptamers offer advantages over antibodies, including lower immunogenicity and toxicity, better tissue penetration, lower production costs, and a very long shelf life. Why, then, have we not seen more of these come to market? Two hurdles have stood in the way until recently.

  4. Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing 5/24/2023

    During my career as an executive in pharmaceutical manufacturing quality assurance, I have heard the term “cost of quality” (COQ) over and over when advocating for budget and resources. Most people think that it is just an excuse for higher costs, but that is not true. I'll share what is involved in calculating the COQ and why it's important.

  5. FDA Adopts ICH Guidance On Assessing Nonclinical Biodistribution Of Gene Therapy Viral Vectors 5/23/2023

    An important step in the gene therapy development process is assembling biodistribution data in suitable animals in relation to the intended clinical population. Developing an accurate biodistribution profile is influenced by factors such as the route of administration, dose level(s), dosing regimen, and the animal immune response to the gene therapy product. The FDA adopted this ICH guidance in May 2023, and the EMA plans to adopt it in September 2023.

  6. Best Practices For Raw Material And Supplier Management For Cell & Gene Therapy Manufacturing 5/23/2023

    One aspect of the complex cell and gene therapy manufacturing process is often neglected or underestimated: the sources and quality of the materials used. Employ this article's best practices and strategies for ensuring supply continuity and the phase-appropriate qualification of materials.

  7. All You Need To Know About Contamination Control Strategies, Part 2 5/22/2023

    In the second of this two-part series, microbiology and contamination control specialists Vanessa Figueroa and Greg Gibb continue discussing best practices in contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I. Discussion includes the elements typically found in a CCS, who in your company is responsible for developing the CCS, how often it needs to be evaluated, and more.

  8. Part 2: What You Should Expect from A High-Functioning CDMO 5/22/2023

    In their second article of this two-part series, the authors detail how to make the partnership between the cell and gene therapy company and CDMO mutually successful.

  9. Where Fly-Fishing Meets mRNA: The Art Of mRNA Immunogenicity 5/22/2023

    In the final installment of this two-part series comparing fly-fishing and mRNA immunogenicity, I summarize some of the basic immunology-centric underpinnings of our mRNA development efforts and the enduring immunogenicity questions and concerns shaping and re-shaping these efforts today.

  10. Optimizing Digitalization To Accelerate Your R&D 5/19/2023

    Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.