Piramal Pharma Solutions, Epirium Bio collaborate on manufacturing program for orphan drugs

Piramal Pharma Solutions, a leading contract development and manufacturing company (CDMO), announced that it has partnered with Epirium Bio in an exclusive manufacturing relationship for new orphan drugs targeting rare diseases with high unmet needs.

The Piramal Pharma Solutions (PPS) team provides Epirium with an integrated program that includes formulation development, delivery of APIs and intermediates, chemical development and manufacturing, and a solid drug product for oral administration. 

The work will be carried out at three PPS locations in India and will be linked to a seamless alignment of information, technology and project management, which will accelerate the passage of time and bring the drugs to market faster, Piramal said in a press note.

Peter DeYoung, Chief Executive Officer of Piramal Pharma Solutions, said, “This program with Epirium illustrates how we are leading the market in providing integrated services. We have reintegrated our supply of intermediate products to ensure the safety and quality of the supply chain. We have invested over a million dollars to add a dedicated area to our facility with the specialty technologies required to manufacture Epirium’s product and we have developed a fully integrated process that leverages the expertise of our teams in three locations. “

Dr. Sundeep Dugar, Epirium’s Chief Technology Officer , added, “Our scientific discoveries have led to the discovery of a novel pharmacological approach to the treatment of diseases characterized by mitochondrial exhaustion and dysfunction. The proof of concept was 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 needs. We expect that our partnership with PPS will accelerate these efforts and help us bring quality orphan drugs to market. “

According to the Company’s press release, the first cycle from the manufacture of a drug substance to the manufacture of the drug itself was successfully completed by the integrated program of PPS. Further cycles are underway, as are further developments that will benefit future indications and new clinical programs.

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