- Recipharm has inaugurated new parenteral development and sterility laboratories at its Bengaluru site, expanding its CDMO capabilities in sterile pharmaceutical product development and analytical testing.
- The facilities support formulation, feasibility, and stability studies for injectable products, alongside sterility testing, endotoxin analysis, and particulate matter evaluation.
Recipharm, a global contract development and manufacturing organisation (CDMO), has officially opened parenteral development and sterility laboratories at its Bengaluru site in India. The purpose-built facilities extend the company’s capabilities in sterile pharmaceutical product development and analytical services, complementing its existing strengths in oral dosage and advanced therapies.
The parenteral development laboratory is designed to accelerate the creation of generic and proof-of-concept injectable products. It handles formulation and feasibility studies for solutions, suspensions, and lyophilised powders, supporting activities such as pre-formulation studies, prototype batch preparation using Quality by Design (QbD) principles, analytical testing, stability evaluation, and compatibility studies. These functions provide a direct pathway to cGMP-compliant and aseptic manufacturing, utilising Recipharm’s small batch production lines for clinical supply, including ReciDev™ PFS and ReciDev™ SFF.
The sterility laboratory broadens the company’s analytical and quality testing capabilities. It provides validated sterility testing via membrane filtration and direct inoculation, bacterial endotoxin testing using gel clot, turbidimetric, and kinetic chromogenic methods, and particulate matter analysis for both viable and non-viable particles. These capabilities are integrated into Recipharm’s analytical centre of excellence, which also conducts pharmacopeia testing, stability studies, and extractable, leachable, and elemental impurity analysis.
“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 rigour in the development of sterile pharmaceuticals.”
Dr. Uwe Hanenberg, Head of Product Development at Recipharm
The new laboratories strengthen Recipharm’s ability to deliver regulatory-aligned, science-driven testing services globally. The Bengaluru site complements the company’s advanced therapy analytical services centre of excellence in Cuxhaven, Germany, supporting a comprehensive CDMO offering from development through to commercial manufacturing.
