cGMP Manufacturing Support
A successful formulation development should always result in the manufacture of robust and stable products. Sai recently passed its first FDA audit for formulation development without any 483’s.
Sai can support clients to handle clinical supplies in various ways: up to phase 2a cGMP supplies can be handled from our Pune site. For Late Phase 2b and 3 supplies, we have, within our reach, a number of CMOs having FDA/EU approvals for cGMP manufacturing. We can work with the clients to give them access to the CMO, ensure smooth tech transfer and manufacture of clinical supplies. The GMP sites have been audited by relevant regulatory bodies and can be audited by the client QA.
Sai’s formulation development facility is based in Pune. A lab space of 20,000 square feet designed to house labs for pre-formulation, formulation dosage form design, analytical laboratories and in a separate block, labs to handle development of formulations of highly potent compounds.
The formulation development laboratories are equipped for handling solid oral dosage forms (tablets and capsules) as well as parenteral dosage forms (liquid and lyophilized injections).
For the solid oral dosage design, we have equipment which allow the scientists to experiment with a wide variety of platforms such as direct compression, wet granulation, roller compaction, fluidized bed coating, bi-layered tablets, coating. Similarly, the lab for injectable’s is equipped with laminar flow hoods, dry heat sterilizer, autoclave, membrane filtration sets for aseptic filtrations, lyophilzer.
For preparation of Liposomes, we have high-pressure homogenizer, probe sonicator, minimate system, Malvern Zetasizer. The pre-formulation lab houses DSC, TGA and moisture sorption analyser (all by TA instruments), Rigaku miniflex II XRD analyser, Malvern PSD analyser.
The analytical laboratories are spread over 9000 square feet area. HPLCs (Waters), Dissolution testers, walk in stability chambers (8000 L), GC’s constitute only a partial list of instruments available.
The laboratories for high potent compounds are isolator based designed. Two isolators meeting OEB4 and OEB5 requirement are dedicated for tablet and injectables product development. The isolator for oral solids has equipment such as rapid mixer granulator, fluidized bed drier and blenders integrated within the isolator. The isolator for injectable has also lyophilizer integrated with the isolator for transfer of vials to the lyophilzer.
A complete list can be shared with the client upon request.
Dedicated Oncology Formulation Development Facility (OFDF)
- Dedicated personnel with significant experience
- Isolator based containment control
- Dedicated separate storage for Cytotoxic raw materials and finished products
- Dedicated equipment/instrument for formulation and analytical development
- Robust Deactivation procedure
Key Equipment and Instruments: Oncology
- Lyophilizer integrated with Isolator (B.Size upto 150 vials of 10ml)
- Vial filling and sealing machine
- Blister packaging machine
- Rapid mixer granulator
- Fluid Bed Drier