Kemwell Pvt Ltd, a leading formulations contract manufacturing and development services company, is investing around Rs 200-250 crore to set up an advanced biopharmaceutical manufacturing plant. The funding is from the company's internal accruals and through a private equity partner. The company has entered into a in a strategic collaboration with Boehringer Ingelheim (BI), Germany. The facility will come up at Nelamangala in the outskirts of Bangalore and is expected to be commissioned in two years.
Under the collaboration, the Bangalore-based Kemwell will complement Boehringer Ingelheim's early clinical supply services ranging from full-service process development, manufacture, formulation and fill & finish at the cGMP manufacturing facility. It will have access to the German major's cell line development with the BI HEX technology platform, followed by a preferred access to the large-scale commercial production of its facilities in Europe. "Most importantly, Kemwell and Boehringer Ingelheim will provide the customer with state-of-the-art technology from Europe along with the benefit of low cost manufacturing from India," stated Anurag Bagaria, vice-president, Kemwell.
The Greenfield project which spans over an area of 15,000 sq m will be designed for process development, fermentation, purification and formulation of biologics for early-phase preclinical and clinical studies. The facility will consist of a cGMP drug substance manufacturing facility and a sterile fill and finish facility for drug product with a floor for process development laboratories to support production of protein therapeutics from mammalian-cell culture or microbial fermentation.
"Through the partnership with Kemwell Biologics, Boehringer Ingelheim will strengthen its presence for biologic services in Asia, providing state-of-the-art technologies for economic manufacturing of innovative, high quality biopharmaceuticals," stated professor Dr Rolf G Werner, corporate senior vice president, Corporate Division Biopharmaceuticals, Boehringer Ingelheim GmbH.
According to experts the bio-therapeutics is the future in modern medicine. Drug development in this space is gaining momentum. The size of the global biologics market is valued at $90 billion.
The Kemwell Biologics factory is coming up within the same campus of its existing unit which is dedicated centres of production for tablets, semi-solids and liquids manufacturing as well as pharmaceutical development services. This will allow the company to synergize its current competencies by using existing trained personnel in analytical and quality services at the new facility. However there will be a new team in place for the Biologics business for which Kemwell has commenced hiring of senior management while its facility is being built. The remaining team will be formed once its facility is ready.
Besides it will also provide in-house experts in toxicology and clinical development and partner with Indian clinical research organizations who can now look at economies of scale.
In Biologics too, Kemwell will pitch in with its expertise in contract manufacturing. We find opportunities to supply monoclonal antibodies and we could be a preferred choice based on our existing formulation capability where we are sought-after by leading global pharma majors as a dependable high quality and affordable supplier adhering to stringent time lines, added Bagaria.