East Meets West in Contract Biologics Manufacturing - Pharmaceutical Technology

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East Meets West in Contract Biologics Manufacturing
A joint biopharmaceutical manufacturing facility in India by Kenwell and Boehringer Ingelheim ushers in new era.


Pharmaceutical Technology
Volume 33, Issue 7, pp. 88

Deepening the relationship

The Kemwell–BI joint facility represents two important turns to pharmaceutical outsourcing in Asia: the entry of an Indian CMO in contract biologics manufacturing and a joint facility by Indian and Western CMOs. Unlike the established market for contract small-molecule manufacturing, contract biologics manufacturing in India and China is emerging. Indian and Chinese CMOs compete with Western CMOs in contract small-molecule manufacturing, particularly in early-stage intermediates and generic APIs, and to a larger degree Indian CMOs compete in advanced intermediates and custom APIs. Pure-play CMOs for biologics manufacturing in India are less common and largely serve the domestic market (1).

Recent deals between Western CMOs and pharmaceutical companies with Indian CMOs have involved outright acquisitions of companies or production facilities as well as strategic alliances. These moves have strengthened Indian CMOs' positions in North America and Western Europe and given Western companies access to lower-cost production.

Some notable deals include Piramal's Pharma Solution's (Mumbai) acquisition of Pfizer's former primary and secondary manufacturing facility in Morpeth, United Kingdom (UK), in 2006, and of Avecia's custom-manufacturing business and related manufacturing facilities in the UK and Canada in 2005. In 2008, Dr. Reddy's Laboratories (Hyderabad, India), bought Dow Chemical's (Midland, MI) small-molecules business associated with its UK sites, as well as BASF's (Ludwigshafen, Germany) manufacturing facility in Shreveport, Louisiana, and related contract-manufacturing business for finished pharmaceuticals. Dr. Reddy's started building its custom manufacturing business in 2005 with the acquisition of a former Roche API manufacturing facility in Cuernavaca, Mexico.

Dishman Pharmaceutical & Chemicals (Ahmedabad, Gujarat, India) bought the Swiss-based CMO Carbogen Amcis and I03S, a company specializing in ozone chemistry, in 2006, and the UK-based contract-research company Synprotec in 2005. In 2007, Dishman acquired Solvay Pharmaceuticals' (Brussels) fine-chemicals and vitamin businesses, which included facilities in The Netherlands, and the intellectual property rights for fine chemicals, vitamin D, and vitamin D analogues (4). Jubilant Organosys (Noida, Uttar Pradesh, India), made two key acquisitions in contract secondary manufacturing: Hollister-Stier Spokane, WA) in 2007and Draxis (Montreal) in 2008. And in 2006, Degussa (now Evonik, Essen Germany) formed a long-term, nonexclusive agreement with the Indian CMO Hikal (Mumbai), India) for Hikal to supply advanced intermediates and APIs (3).

Joint facility development and ownership are far less common, although there are some examples. The CRO/CMO Syngene (Bangalore), a subsidiary of the biotechnology company Biocon (Bangalore), opened a dedicated R&D facility for Bristol-Myers Squibb (New York) earlier this year. The CROs Covance (Princeton, NJ) and WuXi Apptec (Shanghai) had announced plans for a joint preclinical facility in 2008, but Covance later announced that it would build the facility alone.

Patricia Van Arnum is a senior editor at Pharmaceutical Technology and guest contributor for Jim Miller while on vacation, tel. 732.346.3072,

Reference

1. P.Van Arnum, "Assessing Market Opportunities in Contract Biologics Manufacturing," Pharm. Technol. 33 (5), 56–60 (2009).


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