GMP manufacturing of sterile fill/finish drug product has been agreed to support Theratechnologies developmental product as it enters into a first-in-humans clinical study
Piramal Pharma Limited’s Pharma Solutions business, a contract development and manufacturing organisation (CDMO), yesterday announced that it is providing Theratechnologies Inc. with GMP manufacturing of sterile fill/finish drug product to support their developmental product as it enters into a first-in-humans clinical study.
The clinical material is being produced at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is recognised globally for its expertise in sterile fill/finish services. It will be used in a Phase I trial for TH1902, Theratechnologies’ lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I trial design includes a dose escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD) and preliminary anti-tumor activity of TH1902 administered once every three weeks in patients with advanced solid tumors refractory to available anti-cancer therapies.
According to Peter DeYoung, CEO, Piramal Pharma Solutions: “Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It’s yet another example of how we are focused on working with our customers to reduce the burden of disease on patients.”