Durham, NC (USA) – March 19, 2019 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biologics industries, today launched Alcami Biologics, the organization’s 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. This comes in response to increased market demand for outsourced biological drug development services.
“For over 25 years, Alcami has been a trusted provider of comprehensive biotherapeutic development and analytical services,” said Alcami President and Chief Executive Officer, Dr. Stephan Kutzer. “Alcami Biologics, our enhanced new biological analytical development and drug product manufacturing platform, prioritizes our pioneering biopharmaceutical customers, whose promising treatment programs are at the forefront of modern medicine.”
“The launch of Alcami Biologics is a significant step forward in the natural progression of our core service offerings and the development of our pipeline,” said Alcami Chief Commercial Officer, Syed T. Husain. “We have better positioned ourselves to meet increasing worldwide demand for customized biopharmaceutical solutions and are driving innovation across our global network.”
Alcami Biologics is supported by three of the company’s cornerstone operating facilities. Its state-of-the-art Wilmington, North Carolina 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, North Carolina 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.
“Our facilities deliver some of the most effective and cutting-edge therapeutics in the world,” said Alcami Chief Operating Officer, Ted Dolan. “We have the right combination of experience, proven track record, robust quality systems, and capabilities to 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).”
Alcami Biologics’s integrated service offerings include analytical development, formulations, and drug product manufacturing of monoclonal antibodies, and all other protein and peptide products. Drug candidates of all biopharmaceutical classification system (BCS) schemes are supported, from BCS Class I through Class IV. Additionally, Alcami Biologics laboratories carry out cell line characterization studies and provide analytical testing and cell bank management for cell and gene therapies. As product development continues through each clinical stage, Alcami Biologics specialists can provide further development and testing as well as drug product manufacturing, sterile fill-finish, and stability services.
“Because of the vast experience of our staff, we are well-versed in the complexities of biologics development,” said Dolan. “We are always willing to come up with creative solutions to challenges associated with these types of products.”
Alcami Biologics staff members are among the company’s longest tenured. Nearly half of the division’s 20-plus employees have been with the company at least 15 years, with a few having supported the business unit since its inception. Available to the workforce is an arsenal of dedicated equipment, including approximately 20 high performance liquid chromatography (HPLC) systems with various modes of detection, four triple quadrupole mass spectrometers (TQMS), and two quadrupole time-of-flight (QToF) mass spectrometers. Inside the company’s Drug Enforcement Administration-compliant parenteral manufacturing facilities, the Alcami Biologics team can sterile manufacture biologics at the same capacity as small molecule products, with vial volumes ranging from 2 to 50 milliliters at clinical to commercial-scale batch sizes.
“Alcami surpasses all expectations as our partner,” said Ipsen Pharma External Manufacturing Technical Director, Antonio Socorro. “[They are] organized, professional, highly knowledgeable, and deliver right, on time, every time. A true pleasure to deal with.”
France-based biopharmaceutical group Ipsen have been Alcami Biologics clients since 2009. Multiple international Ipsen sites have entrusted Alcami with oncology, neuroscience, and rare disease projects ranging from drug product manufacturing to analytical development and stability storage and testing.
Alcami’s biologics capabilities are complemented by the company’s full suite of custom-tailored pharmaceutical services. Across its 10 global locations, Alcami endeavors to bring customer products to patients faster, from concept to commercialization.
Alcami is a world-class fully-integrated end-to-end contract development and manufacturing organization (CDMO) headquartered in North Carolina, with executive offices in Durham and Wilmington. With approximately 1,000 employees operating at 10 global locations, Alcami provides customizable and innovative services to pharmaceutical and biologics companies of all sizes by offering individualized and integrated services across multiple areas. Alcami connects its clients with innovative solutions for API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services.