Cell and Gene Outsourcing

  1. A Maverick Gene Therapy Manufacturing Strategy 6/11/2021

    Sio Gene Therapies CEO Pavan Cheruvu explains the company’s rationale for migrating away from a hybrid in-house/CDMO manufacturing model to a fully insourced one. 

  2. Beyond CDMO To Trusted Partner: An Interview With Peter Khoury, President And CEO, Ology Bioservices 6/7/2021

    Ology Bioservices is a US-based biopharmaceutical CDMO providing CGMP (and non-GMP) services for the development and production of cell and gene therapies, viral vectors, oncolytic viruses and vaccines against infectious diseases and cancer.

  3. Qualification Considerations For A “Factory-in-a-Box” 6/7/2021

    The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. Enter the "factory-in-a-box," which can be a game-changer for the industry.
     

  4. Streamlining And Standardizing Cell And Gene Therapies From Process To Product 5/27/2021

    Cell and gene therapies are transforming the lives of patients with various rare genetic diseases and more common conditions such as cancer. However, the rapid pace of scientific progress has overwhelmed supply infrastructure, creating pressures to scale manufacturing, increase capacity and meet a wide range of deliverable requirements.

  5. 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.

  6. Integrating Ancillary Systems – A Bridge To Closed Cell Therapy Manufacturing Processes 5/18/2021

    The next phase of growth in the CGT industry is expanding automation into ancillary processes. Although lessons can be learned from the current biopharmaceutical sector, the material and packaging requirements for CGT are unique. As a response to this need, platforms have been established to support the specific needs of this industry. 

  7. How CCRM's Unique Approach Enables Client Success 5/18/2021

    Innovative CDMO services enable the development and commercialization of cell and gene therapies and regenerative medicine-based technologies. Explore how the four pillars guide our work with clients, with examples from Avectas and DiscGenics.

  8. Cell & Gene Therapy Bioprocessing: Demand For Better Process Control, Expertise & CMOs 5/14/2021

    Manufacturing capacity for both cell therapies and gene therapy viral vectors remains in short supply. From BioPlan Associates, Inc.'s new survey of biopharmaceutical manufacturing professionals, there is a current and worsening capacity crunch. The industry continues to demand innovative solutions from its suppliers in key areas that can be slow to develop. 

  9. Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions 4/21/2021

    Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of adeno-associated virus (AAV) delivered gene therapy and messenger RNA (mRNA) vaccines and therapeutics. Plasmid DNA sequences often present challenges with certain notorious regions, such as inverted terminal repeats (ITRs) in constructs containing transgene sequences and long poly-A tail contents in mRNA template plasmids.

  10. Reliability And The Future Of Cell & Gene Therapies 4/19/2021

    Mayo Pujols, CEO of Andelyn Biosciences, discusses how companies are focusing on reliability and predictability to further advance this innovative therapy.