INSIGHTS ON CELL & GENE OUTSOURCING ISSUES

• FDA Accepts GMP Plasmid DMF And Capacity Expansion Enabling Andelyn Biosciences To Offer Faster Gene Therapy Development

  Andelyn Biosciences, a pioneering cell and gene therapy CDMO born out of Nationwide Children’s Hospital, announced the U.S. FDA's acceptance of its GMP plasmid DNA drug master file (DMF), which enables the organization to vertically integrate its clients’ manufacturing process, condensing timelines for developers to begin manufacturing to just three months.

• Solving Cell & Gene Therapy Capacity Shortages: End-To-End CDMO Services

  Hear insights on what it takes to help solve the industry-wide capacity issue, and learn more about one of the only global CDMOs uniquely positioned to help immediately produce new C&GT products.

• CCRM Launches Venture Investment Arm: CCRM Enterprises

  CCRM, a leader in developing and commercializing regenerative medicine technologies and cell and gene therapies, has launched CCRM Enterprises Inc. to distinguish its not-for-profit operations from its for-profit commercial and investment endeavours. This new entity will invest in promising startups, early-stage regenerative medicine-based technologies, and cell and gene therapy companies.

• AGC Biologics Cell Therapy Capabilities

  AGC Biologics develops and manufactures diverse cell therapies including CD34+ hematopoietic stem cells, autologous and allogenic T-cells, and NK cells. Our cell therapy capabilities cover numerous technologies, ranging from closed to open systems at different scales, depending on client needs.

• Robust, Scalable Manufacturing: N-Linked Glycan Analysis For Complex Glycoproteins

  An established cell line and a bench-scale manufacturing process for a complex glycoprotein produced high quality material but had a low yield and was not scalable.

• Post-Discovery Priorities: Streamlining Your Molecule’s Route To IND

  Four experts in post-discovery strategy answer questions about critical considerations that impact timelines and commercialization and share insights related to methodologies, robust platform process design, high-throughput automation technologies, optimized workflows, and lifecycle approaches.

• CCRM Enterprises Invests In Mediphage’s Novel Gene Therapy Platform

  The investment from CCRM Enterprises will be used to fund the development of the technology and ongoing operations, and includes access to CCRM’s scientific and manufacturing expertise.

• The Benefits Of Streamlining And Standardizing Plasmid DNA For Cell And Gene Therapies

  The need for greater volumes of high-quality raw materials like plasmid DNA in the cell and gene therapy space has made pDNA standardization integral to streamlining the development process.

• Steps To Consider For Implementing Continuous Bioprocessing

  Though process intensification has obvious efficiency improvement benefits, it can be challenging to implement. What steps should companies take as they move towards more modern operations?

• Process Development Collaboration Gets Therapies To Patients Faster

  Choosing an experienced manufacturing partner who understands the ins and outs of gene therapy can make a huge difference to the success of your project while helping you meet the needs of patients faster.