01.12.21 -- ASGCT's 2020 Recap

Here are my highlights on an International Society of Cellular Therapy (ISCT) 2020 session that introduced a new way to ship and transport cellular materials, putting patients front and center.

The breadth of digital PCR (dPCR) applications continues to grow and fulfill critical scientific needs. One of the major advantages the technology confers is the ability to count nucleic acid molecules directly, rather than extrapolating quantity based on standard curves as with many other methods. By harmonizing diagnostic procedures on dPCR platforms, the scientific and medical communities can become more coordinated and efficient than ever before.

A minimal amount of available API poses major challenges when filling a product, making process efficiency a critical factor in reducing waste and improving the yield for small batches of drug product.

Computer software assurance (CSA) for manufacturing, operations, and quality system software guidance: Is it the solution to arduous validations that the life sciences industry has been waiting for from the FDA?

Gene and cell therapies have the potential to revolutionize the treatment of incurable diseases, which are often debilitating, if not fatal. Eight emerging and novel uses for osmolality testing in advanced therapy production are outlined in this white paper.

Thermo Fisher’s stepwise approach to quality by design (QbD), an approach that drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign.

Degraded samples are common and certainly problematic for investigators. Read more about common causes of degradation as well as agents and systems available to protect against freeze-thaw.

Precision oncology promises a new standard of care where therapies are tailored to the molecular profile of a specific tumor. For the full potential of precision medicine to be realized, regulatory, technical, clinical, and economic frameworks will need to evolve to the nuances of these novel treatments.

A GMPcompliant, novel process sampling solution for taking multiple conical tube samples at varying time points results in immediate process efficiency and sterility assurance.

Putting cell and gene therapies into practice requires complex logistics. Small batches of either primary cells, viral vectors, or media are supplied and delivered between biopharmaceutical companies, biotech companies, CMOs, CDMOs, hospitals, and other suppliers. The cells used for these therapies pass through several process steps and must be managed as well as transported between these stakeholders in a fast, sterile, and seamless manner.