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Process Development Advisory
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Process Development Advisory
We collaborate with you to design processes that are robust and facilitate transfer to manufacturing, ensuring reproducibility batch-to-batch
The key to successful product launch is to avoid the pitfalls of designing processes that are not scalable from the bench scale to reproducible ease of manufacture.
New products often involve conceiving and developing innovative process solutions. You can collaborate with Dr. Bawa to customize processes to address product needs and successfully take product concepts from the laboratory through the pilot scale to robust manufacturing processes.
At Bausch & Lomb, attacked a critical manufacturing problem. Identified cause, developed and implemented solution leading to cycle reduction from seven months to 3 days. Success led to development and marketing of second lens following same developmental model.
- Invented and developed innovative lens production processes based on supercritical fluid technology that allowed development and successful marketing of cutting edge new products for the global marketplace.
- At Atrix Labs, developed innovative processes for powder filling of drugs as well as lyophilization of injectable polypeptides in plastic syringes. This enabled the development of commercial scale production of leuprolide acetate currently marketed as ELIGARD®
- Conceived and implemented development and regulatory strategies resulting in the rapid approval and marketing of unique injectable, in-situ gelling formulations for the treatment of prostate cancer. Resulted in a multi-million dollar contract with European partner Indivior, PLC for extended release buprenorphine (for treatment of opioid induced addiction) marketed as SUBLOCADE®
Representative Patents:
“Treatment Of Contact lenses With Supercritical Fluid”
USP #6,071,439 (2000), R. Bawa, F. Tasber and D. Hahn
“Method for Lyophilizing an Active Agent”, USP#7,467,482 (2015), C.L. Yarborough, D.G. Madril and R. Bawa
“System for Use in Lyophilization Comprising Delivery Containers and a Cover Plate”, USP#6,610,252, (2003) D.G. Madril, C.L. Yarborough and R. Bawa
Dr. Bawa’s Chemical & Biomedical Engineerings’ background and hands-on several decades experience in designing and implementing scalable processes for devices, drugs, and drug-device combinations is a valuable resource available to you. At all the companies that Dr. Bawa has worked for, he invented processes that easily scaled from the lab bench through R&D right up to manufacturing. His list of patents describes several of these practical processes that are reproducible and robust, and eased transfer into manufacturing.
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