Sep 24, 2019 — Fully-Automated, One Of A Kind (GMP Applied) Manufacturing Facility
This facility was constructed in 2018-19 to support our Client’s Biopharmaceutical development program. The Company is active in development of therapeutic proteins for various ailments, and has developed a pipeline of biopharma drug candidates, which are in various stages of clinical trials. It also has developed Novel Biological Entity (NBE) Candidate for cardiovascular diseases. With its current pipeline of Biosimilar and NBE drugs at various stages of regulatory approval, the Company does not need the facility for internal use and looks to divest it and use the funds from the sale into other activities of Pre-Clinical and Clinical development.
The biopharma facility is at a convenient location – in an industrial park near Mumbai and is located on a plot of 6,023 sq. meters (about 65,000 sq. ft).
The facility is a modern, state-of-the-art facility designed following Global Regulatory standards (Critical equipment and processes following 21 CFR) and offers an end-to-end Biological capability from clone to injectable vialing for sensitive therapeutic proteins. It is also equipped with an advanced R&D Laboratory housing Bench Scale and Pilot Scale biologics development facility, capable of cloning, expression, purification and scaling up. Both the lab, pilot and commercial scale facilities can handle critical proteins undergoing Fermentation (of different scales), cell lysis, solubilization, refolding and range of purification processes entailing chromatography and membrane separations.
The Drug Product division can handle Biologics Formulation, Vial Filling, and Lyophilization ranging up to 1.5 million vials in a month of sterile injectable biological drugs. The in-process finished product and RM/PM QC department is equipped will the entire range of instruments, with complete utility support such as WFI, Clean steam, Black steam, Gases and Type 1 -2 water. The Plant Utilities consists of the highest quality Air Handling Units (AHUs), Water Systems and Boiler, Electrical substations and Effluent Treatment Plants (ETPs).
Although the Company is selling just the facility, it is also open to run the facility for the buyer on a contract basis or help recruit and train staff to run it on a consulting basis (or a combination of both).
CERTIFICATIONS AND ACCREDITATIONS
The facility is designed following Global Regulatory Standards (Critical equipment and processes following 21 CFR) and as of September 2019, is months away from getting DCGI (Indian FDA) approval. If a buyer is looking for US FDA approval, it can achieve this fairly easily as it is designed with the idea of passing US FDA and Global Regulatory Standards.
The asking price for the facility is US$25M. It took about 3 years to design the facility and 3.5 years to build it, keeping in mind the Global Regulatory and US FDA standards in mind. To the best of our knowledge, there is no other such facility available for sale and this offers the best cost effective and efficient option for a biopharma company looking to get its products to clinical trials or to market.