Recipharm expands sterile drug development with new labs in India

Recipharm, a global contract development and manufacturing organization (CDMO), announced the inauguration of newly commissioned parenteral development and sterility laboratories at its Bengaluru, India site. The purpose-built facilities reportedly enhance Recipharm’s sterile pharmaceutical development and testing capabilities, expanding its analytical services function and building on its established strengths in oral dosage and advanced therapies, according to the company.

The new parenteral development laboratory is designed to accelerate formulation and feasibility work for injectable products, including solutions, suspensions and lyophilized powders. The facility supports pre-formulation studies, prototype batch preparation using Quality by Design (QbD) principles, analytical testing, stability evaluation and compatibility studies. Recipharm said these capabilities provide a pathway for transition into cGMP-compliant manufacturing, including small batch clinical supply production lines.

The sterility laboratory adds validated sterility testing methods such as membrane filtration and direct inoculation, as well as bacterial endotoxin and particulate matter analysis, according to the company. 

Recipharm said the new sterility lab complements its newly designated analytical services center of excellence in Cuxhaven, Germany, which provides pharmacopeia testing, stability studies, as well as extractables and leachables analysis. Integrating the center with the capabilities of India’s new facilities reportedly aims to strengthen Recipharm’s global network for sterile and advanced therapy testing.