Outsourced Pharma App Notes & Case Studies

  1. Jumpstart Cell & Gene Therapy Commercialization With SUT Learning 3/24/2021

    Single use technologies are expected to play a big role in the commercialization of cell and gene therapies because of their cost, speed, and sterility benefits. 

  2. "Ultra High” Potency Development And Manufacture 1/20/2022

    A biotechnology company with limited experience in the development and manufacture of high potency compounds sought to develop a process for producing a highly potent API used to treat an unmet oncology need.

  3. ADC Separation: Mixed Mode Cation Exchange Chromatography In A mAb Process 6/18/2020

    This application note describes the steps followed and considerations taken during the development of antibody drug conjugate separation using a mixed mode cation exchange chromatography step.

  4. AVROBIO’s Geoff MacKay On Cell & Gene Scalability 10/4/2021

    Geoff MacKay, president and CEO of AVROBIO, talks with The Business of Biotech podcast about the scale up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

  5. Speed To Market – API Large Scale Commercial Manufacturing 1/20/2022

    A pharmaceutical company was looking to partner with a CMO with commercial manufacturing capabilities, large scale assets, multinational sites and exemplary quality systems/US FDA track record.

  6. How Efficient Batch Records Serve Thorough Tech Transfer 10/12/2021

    Combined with traditional, proven tactics for tech transfer success, an innovative approach to batch record preparation can significantly trim development timelines.

  7. Cold Chain Logistics For Cell Therapy Production – A Conversation With Celyad’s Thomas Lequertier 8/23/2021

    Because cell therapies must be stored and shipped at very low temperatures, maintaining a therapeutic’s integrity through cryopreservation has far-reaching implications for both its efficacy and long-term commercial success. Thomas Lequertier, head of the Cell Therapy Manufacturing Unit at Celyad Oncology, recently sat down with the Business of Biotech podcast to discuss how his company has approached cold chain technology for its CAR-T therapies.

  8. Case Study: Recovering A Clinical Trial That Has Been Derailed 10/5/2021

    When replacing your CRO becomes the only feasible option, a partner experienced in such transitions — as well as sensitive to the impact on your timeline and costs — is invaluable.

  9. Overcoming Cell Therapy Supply Chain Challenges 5/11/2021

    For the industry to realize the potential of cell and gene therapies (CGTs), we must develop improved solutions that reliably support the control and transport of critical CGT raw materials and products.

  10. Microcaps Exceeds Stringent Requirements Beyond Taste Masking 10/27/2020

    A particularly bitter pediatric macrolide in powder form had many needs beyond just taste masking. Read how, by combining double coated Microcaps particles with an excipient mixture, all requirements were met and, in most cases, exceeded.