Pharmaceutical firm Alcami Corp., which employs hundreds of its 1,000 workers at its Wilmington facilities, has launched Alcami Biologics, a new biopharmaceutical development, analytical testing, manufacturing and packaging enterprise.
Alcami Biologics will advance the commercialization of a wide range of biological products to treat complex medical conditions with unmet needs, according to a news release.
The launch comes in response to increased market demand for outsourced biological drug development services, the release stated.
Explaining biologics, Catherine Hanley, Alcami's vice president of marketing, said in an email Tuesday, "Biologics are pharmaceutical drug products that are manufactured, extracted or synthesized from biological sources and make up over half of the drugs currently in development. They are more complex, and more delicate products that have the potential to treat rare diseases and diseases like cancer, with fewer toxic side effects than traditional chemotherapy.
"Alcami Biologics was established to meet market demand and prominently position the company on the cutting-edge of medicine."
Asked whether the enterprise would employ more people in Wilmington, Hanley said, "Wilmington is one of three Alcami sites designated to lead our biological products service offerings, and it will therefore be involved as that business grows. We see great opportunities to develop our already highly skilled Wilmington employees as well as the potential to supplement our staff as we introduce new services and technologies."
The company's biologics analytical development and testing capabilities in Wilmington date back to the early 1990s.
"Over the years, we’ve evolved with the industry and increased our capabilities, for example, expanding into cell and gene therapies," Hanley said. "Today, we are continuing to stay at the leading edge of drug development by ramping up our biologics enterprise, particularly in the area of formulations."
Since the company opened its doors, the Wilmington campus has also tested and developed small molecule pharmaceuticals, or those that are chemically manufactured and usually taken orally, Hanley said. Small molecule pharmaceuticals represent most drugs currently on the market, and, in their final product form, are the pills and capsules people are likely most familiar with, she said.
"For over 25 years, Alcami has been a trusted provider of comprehensive biotherapeutic development and analytical services," said Stephan Kutzer, Alcami president and CEO, in the release. "Alcami Biologics . . . prioritizes our pioneering biopharmaceutical customers, whose promising treatment programs are at the forefront of modern medicine."
Alcami's Wilmington analytical testing laboratory provides a broad range of analytical development and testing services for protein and peptide biologics, as well as cell line characterization and analytical testing of cell and gene therapies. The laboratories inside Alcami's Durham Research Triangle Park (RTP) headquarters specialize in bioassay development, and its Charleston, South Carolina, site provides Current Good Manufacturing Practice (cGMP) clinical and commercial parenteral manufacturing and lyophilization services.
Chief Operating Officer Ted Dolan said the facilities can "support every stage of the product development lifecycle, along with exemplary audit records from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and the Medicines and Healthcare products Regulatory Agency (MHRA)."