Production Efficiency Tops List of BioManufacturers Challenges: Survey of Experts Spurs Further Investigation

Nearly half of BioManufacturers identify increasing production efficiency as the biggest challenge that they face. FDA and regulatory uncertainty also topped the list of industry challenges. ASM Resources and BioPlan Associates will issue a follow-up study in December with strategies the industry can use to overcome these hurdles.

For Immediate Release
Contacts:
Joel Ranck
202-544-6595
jranck@lincolnparkcom.com

Wesley Russ, ASM Resources
(202) 331-2906
mailto:wruss@asmrusa.com

Production Efficiency Tops List of BioManufacturers Challenges

Survey of Experts Spurs Further Investigation

(August, 5, 2002 -- Washington, DC) -- Nearly half of BioPharmaceutical manufacturers identify maximizing production efficiency (46%) the most critical issue the sector faces according to a survey of the industrys top experts released today. A study entitled Advances in Large Scale BioManufacturing and Scale-up Production," available in December will advise BioPharmaceutical manufacturers on ways to alleviate this issue.

The call is going out for professionals in the field to maximize production efficiency, reduce production costs and streamline the product development process. Top priorities for manufacturers include understanding emerging technologies, more proficiently benchmarking their work, defining best practices and understanding the requirements for FDA compliance," said Peter Rizik, President and CEO of ASM Resources, Inc (ASMR). An enhanced knowledge of state of the art technology, production standards and industry regulations can increase manufacturing efficiency and speed the approval process, resulting in millions of dollars of additional revenues."

This regulatory uncertainty has meant that manufacturers may still be relying on tried-and-true" technology rather than risk the use of emerging technologies. The industry may be missing out on millions in potential revenues since manufacturers are unwilling to accept the risks involved in obtaining regulatory approval for novel approaches. Perhaps more daunting for the industry is that advances in large scale BioManufacturing have been slowed.

FDA and regulatory compliance issues were the second most often cited industry concern, with 45.1% considering them a critically important factor, according to the survey carried out by BioPlan Associates and sponsored by the ASMR, the venture arm of the American Society for Microbiology. ASMR notes that the issues of production efficiency and regulatory issues are very closely related. While emerging novel technologies may make Biopharmaceutical manufacturing more efficient, understanding the standards required to obtain regulatory compliance, especially for new technologies, is not clear to most manufacturers, according to survey participants.

Need for Additional FDA Guidance

The complexity and time involved in the FDA compliance process are additional challenges that survey participants indicated were important. Experts said the underlying factors behind the industrys confusion arise from broad-based regulations that apply to large industry sectors rather than to specific industry segments. The lack of segment-specific guidance may leave some sponsors of novel technology to navigate the compliance trail alone. Conversely, once a new technology moves beyond research and development and into acceptance and use, the FDA must develop a suitable understanding of the new technology. This is a major source of compliance delays say industry experts.

Few Established Best Practices

Other factors important to the industry included manufacturing standards (29%), the costs involved with production scale-up (28%) and knowledge of emerging technologies (23%). The results of the survey motivated ASMR to develop a resource and clearinghouse of industry best practices in the form of a report slated for release in December 2002. Advances in Large Scale BioManufacturing and Scale-up Production," is intended to provide BioManufacturing decision-makers with the critical information needed to develop more effective production strategies.

There are substantial information gaps in the BioPhamaceutical manufacturing industry," stated Rizik. Because of our role in the industry, weve commissioned an extensive follow-up study report to provide valuable industry knowledge and to recommend strategies that BioManufacturers can implement."

ASM Resources is the venture arm of the American Society for Microbiology. ASM Resources investment focus is the early stage biotechnology market. The organization was established to generate profits in support of an endowment that furthers the educational mission of the American Society for Microbiology. The organizations business is based on evaluating and commercializing scientific and technological advances in microbiology and related fields.

BioPlan Associates, Inc. has provided market assessment and market research to biopharmaceutical and healthcare companies since 1989 (www.bioplanassociates.com).

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