Life After DSCSA Compliance

By |2023-11-20T10:08:41-05:0011/20/2023|

Life After DSCSA Compliance In September, the FDA provided the pharmaceutical industry with a 12-month extension to the Drug Supply Chain Security Act (DSCSA). The FDA states that this “stabilization period” is for the industry to finetune their systems and processes. However, it’s also abundantly clear that the DSCSA compliance deadline remains November [...]

Minimizing COI & COC Risk

By |2023-02-07T13:24:28-05:0002/07/2023|

Minimizing COI & COC Risk 3 Essential Components for Autologous Cell Therapy Facilities Originally Published as a MassBio Guest Blog Autologous cell therapies involve collecting and processing a patient’s own cells, and later administering the processed cells back into the body to treat the same patient. The personalized nature of these [...]

Info Sheet: Cell & Gene Therapy Services

By |2024-02-06T15:15:46-05:0003/02/2021|

Cell & Gene Therapy Services Info Sheet Download PDF Cellular and regenerative medicine introduces a shift in healthcare - the promise of using the body’s own abilities to heal. Innovation in this area is driving dramatic change in the prevention, treatment and cure of diseases and disorders. The nature of cell and [...]

Ensuring the Path to Compliant Analytical Methods

By |2024-02-06T10:27:14-05:0011/06/2020|

Ensuring the Path to Compliant Analytical Methods PDF Version A gene therapy company spent over a decade developing their first-generation product, partnering for many early development capabilities. Then when the product was moving into the final stage clinical development, they bought out the rights and now owned 100% of the molecule. However, [...]

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