cGMP Archives - Medical Design Sourcing

Rentschler Biopharma begins work on new facility in Greater Boston

The contract development and manufacturing organization Rentschler Biopharma (Laupheim, Germany) has begun constructing a new facility in Milford, Massachusetts, next to an existing facility.

The new 22,000-ft2 facility will boost the company’s cGMP manufacturing capacity and its ability to produce complex molecules for U.S.-based clients.

Once completed, the facility will contain space for manufacturing, single-use bioreactors, cleanrooms and warehousing capabilities. Rentschler said the plant’s design will be modular to accommodate evolving client needs and include Pharma 4.0 features to boost efficiency and enhance automation.

The company anticipates the plant to be operational in late 2023.

Milford is a suburb of Boston.

In 2020, Rentschler announced that it had entered into a collaboration with BioNTech (NSDQ:BNTX) related to the BNT162b2 COVID-19 vaccine, which has emerged as one of the most popular such vaccines in the world.

Ambys Medicines opens cell therapy manufacturing facility, presents data on liver cell data

Privately-held Ambys Medicines has announced that it has opened a 52,000-ft² facility dedicated to hepatocyte manufacturing. The facility is certified to current Good Manufacturing Practices (cGMP) regulations.

The company, based in South San Francisco, California, also presented data on its novel bioreactor manufacturing at the Joint Congress of the International Xenotransplantation Association, IXA-CTRMS-2021.

Focused on developing novel treatments of severe liver disease, Ambys says it expects its lead program to enter the clinic in early 2023.

“The concept of hepatocyte transplantation with donor cells has been explored in academic settings for over 20 years,” said Dr. Ron Park, CEO of Ambys Medicines, in a statement. “These past efforts showed that mature hepatocytes were active and that the approach was safe, but further progress has been limited by the inability to generate adequate quantities of high-quality hepatocytes sufficient to drive clinic…

Essent Biologics debuts stem cell offerings for biopharma and cell therapy research

AlloSource (Centennial, Colo.), a central U.S. provider of allograft providers, has founded a separate nonprofit known as Essent Biologics to provide human-derived biomaterials for research. Essent has recently launched a human mesenchymal stem cells (hMSCs) offering for a range of research applications.

“The mission for the nonprofit is to maximize that gift of donation,” said Derek Mathers, head of business development at Essent Biologics.

Each vial of hMSCs contains more than one million cells after thawing. They have a passage level of P0 or P1 to ensure potency.

The company offers stem cells produced under current Good Manufacturing Practices (cGMP) and in accordance with International Society for Cell & Gene Therapy (ISCT) guidelines.

The company’s scientists have discovered a method for isolating cells and scaffold materials from tissue donation. The resulting cells are the first human-derived cell product that doesn’t use animal pro…