Recipharm, a CDMO, opened its newly-commissioned parenteral development and sterility laboratories at its Bengaluru site in India.
The parenteral development laboratory is designed to accelerate the development of generic and proof-of-concept injectable products. Equipped to handle formulation and feasibility studies for solutions, suspensions, and lyophilized powders, the lab supports critical early-stage activities such as pre-formulation studies, prototype batch preparation using QbD (Quality by Design) principles, analytical testing, stability evaluation and compatibility studies, according to Uwe Hanenberg, PhD, head of product development at Recipharm.
These capabilities create a seamless pathway for transition into cGMP-compliant and aseptic manufacturing, in particular when using Recipharm’s small batch production lines for clinical supply (such as ReciDev™ PFS or ReciDev™ SFF), he added.
The lab expands Recipharm’s existing analytical and quality testing capabilities, continued Hanenberg, who added that the lab offers sterility testing through validated methods, including membrane filtration and direct inoculation, as well as bacterial endotoxin using gel clot, turbidimetric and kinetic chromogenic methods.
In addition, particulate matter analysis, covering both viable and non-viable particles, ensures cleanroom compliance and product release support, he pointed out. These new capabilities are integrated into the existing analytical center of excellence, which performs all pharmacopeia testing, stability studies, extractable & leachable and elemental impurities.
“The inauguration of our new parenteral and sterility laboratories in Bengaluru represents another important step in expanding our global capabilities. This investment reflects our commitment to providing end-to-end solutions for our partners, ensuring speed, compliance and scientific rigor in the development of sterile pharmaceuticals,” said Hanenberg,
