Sterile (Aseptic) Filling

Formulation, Filling and Finishing Services CellBios has a complete in-house cGMP manufacturing sterile fill and finish facility to produce cryopreservation solutions. The facility offers a full range of services from preclinical through commercial scale production of liquid-filled parenterals, biologics and medical devices in vials, syringes and other custom containers. The facility is ISO 9001 and 13485 certified, and is DCGI (Drug Controller of India / Indian FDA) inspected for drug and medical device. It was approved by the Indian Medical Council for the production of Dimethyl Sulfoxide (DMSO) & DMSO-Dextran 40, a commercial cryopreservation solutions. The approval was granted following a successful DCGI audit of our manufacturing facility. Sterile fill and finish facility The facility spans 20,000 sq.ft. with dedicated space for manufacturing, clean rooms, laboratories and administrative activities. The fill lines have been installed across the aseptic fill suites. The aseptic fill suite houses the lyophilisation unit and the INOVA VFVM-3031 vial filler. The line has a single star wheel set up and operates at a capacity of up to 75,000 vials per batch with vials ranging between 2ml and 100ml. It performs automated filling and capping and offers a three-fill needle format including pre-gas purge, product fill and post-fill headspace. It also has a unique suction stopper placement, inline class 100 capping area and an online automated inspection facility. Other specifications of the line include a low hold-up volume of up to 30ml. Custom container filling capabilities within the facility include small volume fills up to 1 L in screw-top bottles and mini vials. Production The facility undertakes all aspects of formulation / filling / finishing of drugs from the pre-clinical phase to the commercial phase of development. It offers syringe, vial and custom container filling services, lyophilisation services and stability optimisation services (SOS) for both small molecule drug products as well as biological drugs