27 August 2020 | News
Integrated program encompasses formulation development, drug substances and drug product manufacturing
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Mumbai based Piramal Pharma Solutions, a leading contract development and manufacturing organization (CDMO), has announced that the company will be partnering with US based Epirium Bio on an exclusive manufacturing relationship for new orphan drugs targeting rare diseases with high unmet needs.
The Piramal Pharma Solutions (PPS) team is providing Epirium with an integrated program that encompasses formulation development, supply of APIs and intermediates, chemistry development and manufacturing, and solid oral dosage form drug product.
The work is being completed across three PPS sites in India, with the seamless alignment of information, technology, and project management that will speed timelines and bring the drugs to market faster.
According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, “This program with Epirium exemplifies the ways we lead the market in delivering integrated services. We’ve back-integrated our supply of intermediates to ensure supply chain security and quality, we’ve invested more than $1 million to add a dedicated area to our plant with the specialized technologies required to produce Epirium’s product, and we’ve developed a fully integrated process that utilizes the expertise of our teams at three sites.”
Dr. Sundeep Dugar, Chief Technology Officer for Epirium, added that “Our scientific insights have led to the discovery of a novel pharmacological approach for the treatment of diseases characterized by mitochondrial depletion and dysfunction. Proof of concept has been established in early human studies and we intend to advance our clinical candidate as a potential treatment for certain relevant rare diseases with high unmet need. We expect our partnership with PPS to expedite these efforts and help us bring high-quality orphan drugs to market.”
The first cycle of drug substance to drug product has been successfully completed through the integrated program. Additional cycles are in progress, as are further evolutions that will benefit future indications and new clinical programs.