Piramal Pharma Limited’s (PPL) Contract Development and Manufacturing Organisation (CDMO), Piramal Pharma Solutions (PPS), has announced that the Company has entered into a Master Services Agreement (MSA) with Plus Therapeutics for Piramal to perform services related to the development, manufacture, and supply of Plus Therapeutics’ RNL-Liposome Intermediate Drug Product.
This MSA includes the transfer of analytical methods, development of microbiological methods, process transfer and optimization, intermediate drug product manufacturing, and stability studies. The transfer will be performed at the PPS drug product facility located in Lexington, Kentucky. The two Companies envision that the MSA will lead to clinical and commercial supply agreements for the drug product at the appropriate stage of development.
PPS’ Lexington site is recognized as a North American leader in the formulation, development and manufacturing of sterile parenteral drug products. The Lexington site has the capability to support drug development for New Chemical Entities (NCEs), generics, and molecules that might be following the 505(b)(2) regulatory pathway.
Peter DeYoung, CEO, Pharma Solutions, Piramal Pharma Limited, stated that, "We are excited to partner with Plus Therapeutics. We believe that this represents the start of a long, collaborative and mutually beneficial relationship that will address our ultimate objective of reducing the burden of disease on patients."
“This agreement represents another significant milestone for Plus, as we work to advance development of RNL as a novel treatment option for patients diagnosed with glioblastoma,” said Marc Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. “The team at PPS has the knowledge, experience and expertise to support our needs, both now and in the future as we advance RNL towards regulatory approval.”
