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Clinical material for a Theratechnologies product in development will be produced at PPS’ manufacturing facility in Lexington, KY.
Piramal Pharma Solutions (PPS), a US-based contract development and manufacturing organization, announced on Jan. 21, 2021 that it will provide Theratechnologies, a Canadian biopharmaceutical company, with good manufacturing practice (GMP) manufacturing of sterile fill/finish drug product to support TH1902 (docetaxel conjugate), Theratechnologies’ peptide-drug conjugate developmental product, as it enters into a first-in-humans clinical study.
Under the terms of the partnership, clinical material for the product will be produced at PPS’ manufacturing facility in Lexington, KY, to be used in a Phase I clinical trial, PPS said in a company press release. The trial will evaluate the safety, pharmacokinetics, maximum tolerated dose, and preliminary anti-tumor activity of TH1902 in participants with advanced solid tumors refractory to available anti-cancer therapies.
“Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material,” said Peter DeYoung, CEO, PPS, in the press release. “It’s yet another example of how we are focused on working with our customers to reduce the burden of disease on patients.”
Source: Piramal Pharma Solutions