Cell and Gene Regulatory

  1. Single-Use System Design For Cryogenic And Cold Temperature Operations 6/2/2021

    Single-use technologies have been a valuable tool to help speed to market cell and gene therapies. Cryogenic operations play a critical role in many processes. Join Ross Acucena, applications director, discusses single-use system design for cGMP cryogenic operations.

  2. Shortening The Time From Start To Finish Pt. 2/3: Continuous Improvement & Kaizen 5/27/2021

    This episode covers our continuous improvement efforts and company-wide practice of Kaizen, what it is, and how it has impacted our operations and project delivery and efficiency.

  3. Q&A: API Experts — A Small Molecule’s Journey Through API Development 5/26/2021

    Developing a small molecule API is often a perilous process for new and emerging pharma companies. Three leading API experts discuss the key challenges, what your company needs to succeed, and how partnering with a capable CDMO can make the biggest difference of all.

  4. Clinical Strategy For Successful Cell And Gene Therapy — How Did I Get Here? 5/3/2021

    There are major challenges to the widespread adoption of cell therapies, primarily related to the high manufacturing costs of what is largely a manual process with complex logistics and supply chain. Experts share their experiences and discuss emerging trends in the field to accelerate life-saving therapies from the bench to the bedside.

  5. Strategies For Startups — How To Structure Milestones For Successful Outcomes 5/3/2021

    Experts from the cell and gene therapy field share their experiences and discuss trends to accelerate therapies from the bench to the bedside, with specific focus on strategies for start-ups, how to look at robust scale-up, and reducing CMC risk.

  6. Attracting The Right Capital — Forming Partnerships For Long-Term Success 5/3/2021

    Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.

  7. Key Changes In The Revised EMA Guidance On Clinical Trials During COVID 4/26/2021

    In February, the European Medicines Agency (EMA) released the fourth version of its Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic. As the pandemic continues to impact clinical research worldwide, these updated guidelines reflect the EMA’s evolving stance, clarifying questions raised by previous versions and taking into account the most recent changes in the global health landscape. Here’s an overview of what’s new.

  8. Regulatory Requirements Featuring bluebird bio 4/26/2021

    Just recently, I had the chance to sit down with Matt Pillar and bluebird bio’s VP Regulatory Operations and Compliance, Scott Cleve, for a candid discussion on the regulatory trends shaping the advance of bluebird’s pipeline of gene therapies for the treatment of serious, life-altering diseases including Cerebral Adrenoleukodystrophy, Multiple Myeloma, Transfusion-Dependent β-Thalassemia, and Sickle Cell Disease.

  9. Reducing Human Error In Gmp Pharma/Biopharma Operations 4/15/2021

    CAI clients often seek help in closing open investigations, but ignore the source of these investigations, even while product sits quarantined. Where clients really need help is in cutting human error off at the source. This blog explores the factors within an organization’s control that impact ongoing human performance.

  10. How To Attract Investors – Funding Advice For Biotechs From VC Experts 4/9/2021

    How do you find the initial capital and attract new investors to hit your milestones and stay solvent? Experts share their experiences and offer advice for companies on the path towards bringing a potentially life-changing therapy to patients.