In a move to keep its home-grown biotech industry, the stateof Maryland has provided $1.5 million to plan and design abioprocessing scale-up facility that will help small companiesproduce their compounds for use in clinical trials.
The facility will adhere to the Food and Drug Administration's"Good Manufacturing Practices" regulations so that scaled-upproduction for FDA trials can occur at the center itself,according to Dr. Jared Cohon. He is chairman of a steeringcommittee for the Maryland Bioprocessing Scale-up Facility,which includes Maryland-based biotechnology companies, thestate government and Johns Hopkins University in Baltimore.
Construction of the $22 million facility could begin in thesummer of 1992, and the facility could open in late 1993 orearly 1994, said Cohon. As planned, 10 to 14 companies wouldbe able to use the facility annually.
Cohon said the method for state funding of the remainingcapital had not been determined.
"Maryland ranks third in the nation in the number ofbiotechnology companies, behind California and Massachusetts,but we are much lower in the rankings if you look at therevenues that those companies generate," Cohon said. "Thisreflects the fact that our companies are young, research-oriented companies."
Cohon said such companies must scale up production forclinical trials just as their resources have been depleted byR&D efforts. "This is a very risky step, and it is an expensiveone that only provides material for testing," he said. "It neverassures that you will be able to sell a product."
Without resources to build their own facility, and with a lackof contract facilities in the state, small companies mustconsider an alliance with a large corporation that hasexpertise, money and facilities for scale-up manufacturing,said Cohon.
"The problem is, there are no large pharmaceutical companiesin Maryland," he said. "And large companies often exact a veryheavy price, like a significant ownership position, often amajority position, in the company.
"The result of this is that the company and/or its product willleave Maryland when they get to the scale-up step. The purposeof this facility is to increase the chances that Maryland willget the economic benefit of the biotechnology industry," hesaid.
-- Kris Herbst BioWorld Washington Bureau
(c) 1997 American Health Consultants. All rights reserved.