Alcami Meets Demand for Parenteral Manufacturing with New RTP & Charleston Fill-Finish Capacity
To meet increased market demand for parenteral manufacturing, leading CDMO Alcami has announced the strategic expansion of its sterile fill-finish manufacturing capabilities and capacity for a total of six fill-finish lines. Two lines on Alcami’s Charleston, South Carolina, campus, and four lines on its Research Triangle Park, North Carolina, campus now offer immediate capacity for small and large molecules, from preclinical product development to commercial launch and supply. Clients obtain the additional benefits of full integration with the company’s network of formulation development, packaging / labeling, lab services and pharma storage and services facilities.
The expansion aims to meet growing industry demands for onshore sterile fill-finish capabilities amidst supply constraints, industry consolidation and tightening capacity as the pipeline of biologics and specialty therapeutics continues to grow.
“In a tight market, capacity is at a premium and conditions favor those with immediate capabilities. As Alcami continues to align with the future of pharma and biotech, we’re meeting increased demand with these new sterile fill-finish manufacturing lines on our Charleston and RTP campuses,” said Bill Humphries, CEO of Alcami. “Because Alcami offers integrated services through every stage of the development lifecycle, we can help clients mitigate supply chain risks by providing onshore, streamlined and cost-efficient solutions. We’re committed to offering the latest manufacturing, analytical and storage capabilities and plan continued expansion of our manufacturing capacity to help bring our clients’ innovative therapeutics to patients.”
The success of sterile fill-finish manufacturing relies on mitigating contamination from multiple sources - personnel, drug product components, container-closure systems, cleanroom facilities, equipment and process. As new and complex drugs become more common, it is critical to partner with a trusted CDMO like Alcami with more than 23 years of parenteral manufacturing experience and a more than 45-year track record of client success.
With the ability to onboard projects quickly, Alcami can initiate GMP manufacturing in a matter of weeks. The company offers a versatile and holistic set of sterile fill-finish capabilities to support all types of projects covering both small molecules and biologics/large molecules. Clients also benefit from Alcami’s extensive expertise with mAbs, peptides, oligonucleotide/Ab conjugates, enzymes, nanoparticles and micellation. The state-of-the-art fully automated GMP sterile fill lines offer the flexibility to fill liquid and freeze-dried vials under isolator technology to minimize the potential for contamination, with capabilities including pre-filled syringe, terminal sterilization, suspensions and emulsions, lyophilized vials, single-use systems, bulk temperature control and DEA controlled substances.
Alcami’s parenteral manufacturing sites in Charleston and Morrisville (RTP), are fully US- and EU Annex 1-compliant and DEA-licensed.
Listen to Outsourced Pharma’s webinar where Alex Drennan, Alcami’s Director of Manufacturing, speaks about recent capacity updates and learn more about Alcami’s sterile-fill capabilities.
