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
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.