Communication and Effective Technology Transfer Key to Successful Outsourcing

By Lori Malvey

Bio Science Contract Production Corp., a Baltimore, MD-based contract manufacturer, believes the key to successful outsourcing lies in the effective transfer of technology that describes production, and clear communication throughout the project lifecycle. Bio Science chaired the session "Effective Transfer at Various Stages of Product Development" at BIO '98, the Biotechnology Industry Organization's annual meeting held in New York City (June 14-18). At the session, speakers Roger Lias of Lonza Biologics Inc., Joseph Fischer of Enzon Inc. and Michael Beatrice of Quintiles, related their experiences on technology transfer from the perspective of both the service provider and the client.

After the meeting Pharmaceutical Online discussed Bio Science's business strategy with the firm's management. "We have a Technology Management Department that oversees project communication before the job begins and during manufacturing," stated Louise Campbell-Blair, VP of business development. "We review the client's expected production timeline, their process and supporting data, and together come up with a realistic technology transfer plan to meet their goals. In addition, we hold client/contractor weekly meetings, and provide monthly reports to ensure project objectives are clearly met." Bio Science's Technology Management Department develops, optimizes or scales-up processes according to a client's request, and recommends improvements to existing processes.

Unlike some other contract manufacturers, who seek to acquire ownership of a process or product, or to "partner" with their client firms, Bio Science does not view this as their role. Management clearly distanced themselves from the philosophy that contract manufacturers and their clients should become partners. "We differ from other contract manufacturers in that manufacturing is our only business, one hundred percent," added Ms. Campbell-Blair. "We do not own the product, process, or process development in any way. Even if we aid the client in ways that warrant a copyright or royalty, we do not take it. It belongs to the client."

Bio Science's commitment to outsource work exclusively is further explained by Jacques R. Rubin, Chairman and CEO. "We are not engaged in developing our own intellectual property. In fact, we protect clients' intellectual property. That gives clients extra assurance that their most valuable assets—their trade secrets—are safe with us. This is especially important in development and scale up, when we frequently help clients refine their production processes. Any improvements we participate in are the sole property of the client."

Bio Science operates a 54,000 sq. ft. manufacturing facility in Baltimore, Maryland, which began cGMP operations in 1996. It was the first dedicated contract manufacturing organization for bulk biologics in the US. The facility has 10,000 sq. ft. of classified clean rooms segregated into four production suites—three of which are dedicated to microbial fermentation and one to mammalian cell culture. The suites are equipped for up to 1500L fermentation or 130L cell culture. The firm performs cGMP production of intermediate or purified bulk biologics and pharmaceuticals. The facility is available to companies on a per diem or contract basis. The firm also provides flexible client-oriented production capabilities for both short-term and long-term contractual agreements, and will support the client with regulatory documentation required for FDA filings.

For more information: Louise Campbell-Blair, VP Business Development, Bio Science Contract Production Corp., 5901 East Lombard St., Baltimore, Maryland 21224. Tel: 410-563-9200, ext. 305. Email: lcampbell-blair@bscp.com.