By Eric Langer, president and managing partner, BioPlan Associates, Inc.
China’s predicted emergence as biopharma’s top outsourcing destination by 2015 highlights some very challenging issues in its evolving GMP situation. China is developing into a new outsourcing competitor, despite the fact that its international pharmaceutical manufacturing history spans only slightly more than a decade. Until recently, such biopharma product manufacturing was prohibited by the Chinese government. Even today, while outsourced production of clinical material is acceptable, commercial production by contract manufacturers is not permitted.
Nonetheless, responses from a majority of the 352 global respondents who are planning to outsource internationally ranked China as their top choice in BioPlan Associates’ 2011 Eighth Annual Report and Survey of Biomanufacturing Capacity and Production. Among all respondents, China leapfrogged the United States and India, moving from 7th place (2010) to capture the top spot (Figure 1).
This is not surprising, as the Chinese biopharmaceutical industry takes a strong position in terms of concentration of biopharmaceutical manufacturing. According to www.top1000bio.com, Chinese biologics manufacturers, as of early August 2011, comprised 8.5% of the global biomanufacturing capability, capacity, employment, and pipeline. This compares with 8.0% for India and 37.3% for the United States.
Factors that have given China a fast track to first place as a prospective outsourcing destination include economic growth, opportunities to develop global partnerships, and ongoing government investments in biotechnology. At the same time, however, there continue to be significant reservations. Management decisions must weigh the significant challenges to China’s outsourcing partners. Chief concerns include:
changes in Chinese regulatory environment
cross-cultural management challenges.
A key factor in this equation relates to the CMO selection process itself and organizational interactions. In 2011, the BioPlan report showed that in the CMO/biomanufacturer relationship, “quality” is consistently perceived as important. Other high-ranked selection factors for CMOs were:
comply with my company’s quality standards (59.1%)
protect intellectual property (56.8%)
effectively handle cross-contamination issues (52.3%)
stick to a schedule (48.9%)
establish a good working relationship (45.5%).
The “Very Important” and “Important” responses shown in Figure 2 form a high-level CMO evaluation checklist against which fledgling Chinese CMOs must perform. Most of the 100+ Chinese biopharmaceutical facilities today have approval for making material for China and some for export, but not for U.S. or EU markets.
China appears to be directing efforts toward these global priorities. Reports in BioPlan Associates’ monthly BioChina Newsletter illustrate China’s developments in these areas:
Advancing regulatory environment and actions:
— China’s SFDA (State Food and Drug Administration) affected its GMP regulations revision March 1, 2011.
— WuXi PharmaTech received in February 2010 GMP EMEA compliance certification for cGMP manufacturing.
— EMD Millipore opened $2 million Biopharmaceutical Technical Center in Shanghai to support training in China.
Global organizations and consortia in cooperative quality control:
— July 2011, WHO announced a two-year project with China’s SFDA to enhance data exchange on adverse drug reactions.
— March 2011 WHO assessment showed China complying with international vaccine regulation standards.
Government-funded CMO business incubators in over 100 technology research parks:
— ScinoPharm, Kunshan, China, development on contract manufacturing in a new GMP plant.
— Zhongshan National Health Technology Park in July 2011 announced park built in compliance with international GLP (good laboratory practices), GMP, and GCP (good clinical practice) standards.
Over the next five years, China faces huge challenges in scaling up and regulating its facilities to meet its own new and more extensive GMP requirements, as it interfaces with international GMP requirements. A case in point is the late 2010 announcement by the Shanghai FDA that it is still formulating CMO policies for release by 2013. Chinese contract organizations must meet international standards if they are to support international outsourcing. The uncertainty around how China will fully address these complexities over the next five years highlights that, indeed, we will live in interesting times.
SOURCE: BioPlan Associates, Inc.