INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• Your Cell And Gene Therapy Journey: From Discovery To Commercialization

  Thermo Fisher Scientific connects you with the technical expertise, regulatory guidance, and custom or off-the-shelf solutions you need to overcome obstacles, streamline processes and advance your cell and gene therapies.

• Enabling Broader Adoption Of Process Intensification In Biopharma

  PI is becoming increasingly well-understood and its utility is continuously evolving to meet specific manufacturer needs, from product development to manufacturing, whether approached stepwise or end-to-end.

• Accelerating Progress: Key Considerations For CDMOs To Maximize Productivity And Scalability

  Due to the urgent demand for vaccines and treatments, the biopharmaceutical industry is experiencing disruptive changes and increased demand on resources that are requiring a significant operational transformation. To accelerate the delivery of life-saving therapeutics, it is essential to evaluate effective ways to maximize efficiencies and increase capacity while minimizing risk. Flexibility is critical in bioprocessing today to stay up to speed with the quickly shifting needs of the industry.

• Gene Therapy For Rare Disorders Panel Summary

  A panel of industry experts share updates on their current pipelines, development process, and discuss of their unique experiences and lessons learned in leading early-stage gene therapy companies.

• A Maverick Gene Therapy Manufacturing Strategy

  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. 

• Beyond CDMO To Trusted Partner: An Interview With Peter Khoury, President And CEO, Ology Bioservices

  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.

• Qualification Considerations For A “Factory-in-a-Box”

  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.
   

• Streamlining And Standardizing Cell And Gene Therapies From Process To Product

  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.

• Q&A: API Experts — A Small Molecule’s Journey Through API Development

  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.

• Integrating Ancillary Systems – A Bridge To Closed Cell Therapy Manufacturing Processes

  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.