July 1, 2007 (Vol. 27, No. 13)

Company Focuses on Small Clients that Lack Experience Working with Biologics

Goodwin Biotechnology (www.goodwinbio.com) claims to be one of the oldest contract manufacturing organizations (CMO) of mAbs and recombinant proteins in the U.S. In 2004, Wallace Pharmaceuticals (www.wallacepharma.com) of Goa, India, acquired Goodwin Biotechnology, but the Florida facility has continued to operate under its own name. Goodwin is also setting up a biologics manufacturing subsidiary in Goa. “Our strategy is to grow, both here and in India, into a high-quality producer of clinical and commercial biologics,” says Stephanie Finnegan, CEO.

Because of Goodwin’s long history as a reputable manufacturer of biologics, the company hopes that its clients in the U.S., Canada, and Europe will become comfortable with off-shoring projects to India where operating costs are lower. “Everyone talks about offshoring to Asia,” says Finnegan, “but we are among the first contract manufacturing organizations to execute this tactic.” The cost of labor in India runs about 50–75% lower than in the U.S. Since labor accounts for about half the cost of manufacturing biologics, the final costs can be cut by up to 40% by labor savings alone, estimates Finnegan.

Her strategy for making clients comfortable with manufacturing biologics in India starts with performing all of the initial process development and early clinical manufacturing in Florida. Once perfected, the process will be transferred to India where it will be closely monitored and documented to assure clients that the exact steps are being followed. “If they are comfortable with Goodwin Biotechnology in the U.S., then they should be comfortable with Goodwin Biotechnology in India because it will operate as a mirror image,” Finnegan says. Establishing this type of close relationship with clients should knock down reservations about offshore manufacturing.

In addition, Goodwin is seeking to form partnerships with biopharmaceutical firms in India. Although Indian companies excel at making generic small molecule pharmaceuticals, biologics are more difficult to manufacture. Particularly in the early phases of creating biologics, process development is complex and uncertain. Indian companies developing new drugs usually aim for approval from the FDA.

Florida Capabilities

For clients who are not comfortable with having products manufactured in India, Goodwin Biotechnology will continue to manufacture biologics in Florida. In fact, the company is expanding and upgrading its facility in Plantation. In 2005, Goodwin Biotechnology tripled its process development capacity, an expansion that was partly responsible for a growth of 300% that year.

In 2006, the company doubled its GMP-manufacturing space by adding 200-L and 500-L stir tank bioreactors and ancillary equipment. This expands Goodwin’s production capacity from two kilograms a year to about eight kilograms a year. By the end of 2007, Finnegan expects to add 20 employees to the current staff of 55 at Plantation.

Goodwin Biotechnology has been manufacturing biologics continuously since the mid-1980s. “We are a smaller contract manufacturer, a second-tier company,” says Finnegan. Goodwin prides itself on serving smaller clients that lack experience working with biologics. “Genentech does not need me to tell it how to make a product,” Finnegan says.

Instead, Goodwin attracts small-to-midsize biotechnology and pharmaceutical companies and researchers at universities, institutions, and government laboratories that benefit from the CMO’s value-added services. “Our niche is performing toxicology and preclinical studies and manufacturing biologics through Phase III trials,” says Finnegan. So far, Goodwin has not made a product for the commercial market, but the company’s long-term strategic plan includes building a commercial production plant in India.

According to Finnegan, Goodwin Biotechnology excels at making mAbs, and it has manufactured more than 300 cell lines. “Every antibody is different, and we adeptly handle difficult subclasses like IgM antibodies,” adds Finnegan. Many established clients are re-engineering cell lines to improve titers to be more cost effective. “It used to be that a quarter of a gram per liter was considered a good yield, but now a gram per liter or more is everyone’s goal,” Finnegan notes.

Lowering costs depends on many factors—including increasing titers through re-engineering of cell lines, optimizing media formulations and other growth parameters, and improving purification yields. “We help clients with all these key process improvements,” she says.

Goodwin offers upstream process development, including cell line evaluation, media selection, and subcloning. Cell banking services such as manufacturing seed, master, working, and postproduction banks are provided. Purification processes are performed with affinity, ion-exchange, hydrophobic, or size-exclusion chromatography, with batch sizes typically ranging from one to 100 grams.

A Class-100 vial facility performs compliant filling of biologics, and the operation is fully validated for fill volumes up to 10 mL/vial. Goodwin’s experts can create conjugation methods to attach a toxin, protein, or isotope to a protein as well as downstream protein purification that meets regulatory requirements.

Goodwin’s predecessor, the nonprofit Goodwin Institute for Cancer Research, manufactured biologics in the mid-1980s in conjunction with its main business of breeding pathogen-free mice for researchers at the NCI. The mice were used to generate diagnostic antibodies for select clients. When Finnegan, an accountant, was called in to sort out issues surrounding the nonprofit institute’s selling of antibodies, “I became enamored at the prospect of starting a contract manufacturer of biologics,” she says.

Finnegan had worked with a CMO that manufactured small molecule drugs and foresaw the need for a CMO to make biologics. She and her husband Michael Finnegan, now Goodwin’s CFO, invested their own money to spin off Goodwin Biotechnology from the nonprofit cancer research institute in 1992, since then the firm has served more than 100 clients.

Finnegan sought out the acquisition by Wallace Pharmaceuticals to obtain capital in order to grow and expand. After a strategic analysis of contract manufacturing in Asia and visits to Singapore, Korea, and India, Finnegan decided that India “has the best chance of success because of savings through labor costs, the absence of a language barrier, and its robust pharmaceutical industry,” she says.

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