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Sterile Fill-Finish Manufacturing

Producing parenteral dosage forms of small and large molecules from preclinical product development to commercial launch

Alcami has over 23 years of experience in developing and manufacturing liquid and lyophilized injectable drug products, including suspensions, emulsions, & controlled substances in both vials and syringes.

Parenteral manufacturing can be a challenging process and pharmaceutical companies need a partner who understands those intricacies and can help successfully scale their process. A recent dramatic increased demand in the pharmaceutical industry has also created a number of unique challenges and investments in extensive planning, trained personnel and highly specialized facilities and equipment.

The success of sterile fill-finish manufacturing relies on mitigating contamination from multiple sources - personnel, drug product components and container-closure systems, cleanroom facilities, equipment and process. As new and complex drugs become more common, it is critical to partnering with a trusted CDMO that has years of experience and a track record of success with clients is critical to success. This will ensure that your product can be produced on a large scale.

Alcami’s parenteral manufacturing sites, which are based in Charleston, South Carolina and Morrisville (RTP), NC. and support clinical production through commercial launch and supply. Our Charleston site is fully US- and EU Annex 1-compliant and this DEA-licensed sterile manufacturing facility has been fully integrated with our Wilmington, North Carolina packaging and distribution center for over 22 years.

Our state-of-the-art fill-finish manufacturing facility in Morrisville/RTP, NC expands our sterile drug product capabilities. This 32,000 ft2 location includes isolator manufacturing capabilities for liquid pre-filled syringes, liquid and lyophilized vials and has also been inspected by the DEA.

Note: (RTP manufacturing is approved for DEA Schedule 3-5)

Our dedicated staff has the knowledge and skills depth and breadth of scientific experience to help advance your product to clinic and market and you can trust Alcami to bring your product and company to the next level.


chs1 ICON (1)



2mL - 50mL



chs1 ICON (2)

Suspensions & Emulsions


  • Dedicated to parenteral manufacturing and laboratory support services
  • OEL Levels: Down to SafeBridge Categorization
    • (3A) lyophilized product = 10-1µg/m3
    • (3B) liquid product = 1-0.1µg/m3 and 0.1-0.03µg/m3
  • Sterile solutions, suspensions, and emulsions, and lyophilized drug product
  • Grade A and Grade B areas: Filling, capping, sterilized component staging ​
  • Grade C: Compounding, component, preparation, microfluidization, sampling/dispensing​
  • Grade D: Equipment washing
  • Development and filling of DEA Schedule I-V and List I Chemicals
  • 100% visual inspection
  • Quality Systems compliant to cGMP regulations for U.S. and EU


RTP1 icon

Formulation Development, Tox Material, Client-collaboration workspace & Analytical Testing


Prefilled Syringes
1mL, 1mL long, 2.25mL and 3mL


2R - 30R



  • Four cGMP filling lines with isolator technology for filling liquid and lyophilized vials and liquid pre-filled syringe products
  • Low line loss, single-use systems for compounding and product transfer processes
  • Aseptic Fill or Terminal sterilization for vials
  • Nitrogen sparging and overlay capabilities in both syringes and vials
  • Incoming materials & finished product storage temperatures: -80°C, -20°C, 5°C, controlled room temperature (CRT), and customized temperatures
  • OEL levels: Down to SafeBridge categorization
    • (3A) lyophilized product = 10-1µg/m3
    • (3B) liquid product = 1-0.1µg/m3 and 0.1-0.03µg/m3
  • 100% visual inspection 
  • On-site laboratory support with non-GMP filling capability to support vials and pre-filled syringes for preclinical studies
  • Lyophilization Cycle Development Center & Client-collaboration workspace for facilitating formulation development and technical transfers
  • Filling of DEA Schedule III-V controlled substances
  • Quality Systems compliant to cGMP regulations for U.S. and EU

See inside our Morrisville/RTP aseptic processing facility


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