Beyond expectations.

Drug Product Manufacturing

Sterile Fill Finish Manufacturing

Drug Product Manufacturing

Formulation Development

Expert sterile fill finish manufacturing services — from preclinical product development to commercial launch.

Parenteral manufacturing poses significant challenges, particularly with the rise of complex and potent drugs, as well as therapies involving controlled substances. To navigate these complexities and successfully scale your process, you need a partner with deep understanding and experience.

With decades of expertise in manufacturing and filling liquid and lyophilized injectable drug products, we are well-equipped to support you from clinical production through to commercial launch and supply. Our capabilities encompass a wide range of formulations, including suspensions and emulsions, in both vials and syringes. Our team is proficient in handling highly potent active pharmaceutical ingredients (HPAPIs) and controlled substances, ensuring your products are managed with the utmost care and precision.

Alcami provides cGMP manufacturing services tailored to match your development and approval timelines. We offer a comprehensive platform for pharmaceutical development with expertise in small and large molecules, lyophilized products, complex formulations, high potency compounds, and DEA-scheduled drugs. Our experienced teams in formulation, analytics, packaging, and distribution ensure seamless progress through the development process, overseen by personalized project managers, supporting optimal outcomes throughout your product’s lifecycle.

Sterile Fill Finish Core Capabilities (6 Fill Lines)
Liquid fill vials
Aseptic filling
ANNEX 1
Bulk temperature control
Terminal sterilization
Pre-filled syringe
Suspensions and emulsions
DEA controlled substances
Lyophilization vials
Single-use systems
Isolator technology

Packaging
Bottles
Vials
Pre-filled syringes
Cartoning
Labeling
Trial kit assembly

Labeling
Clinical labeling
Clinical trial blinding
Commercial labeling
Serialization and aggregation

Storage & Shipment
Long-term storage
Cold chain solutions
Shipment readiness

Sterile Fill Finish Manufacturing

Alcami offers comprehensive sterile fill-finish manufacturing services, specializing in prefilled syringes with capabilities for 1mL long, 1mL standard, 2.25mL, and 3mL syringes, all sourced from qualified suppliers. Additionally, Alcami can accommodate varying vial sizes ranging from 2mL to 50mL, utilizing both ISO R and mL standard size vials. With state-of-the-art facilities in RTP, NC, and Charleston, SC, Alcami is equipped to handle batch sizes of up to 200L and 1000L, respectively. These facilities are compliant with Annex 1 requirements, enabling Alcami to release batches for use outside the US, including the EU.

CHARLESTON, SC
This 74,000 sqft, fully U.S.- and EU-compliant site is DEA licensed and has been fully integrated with our Wilmington, NC packaging and distribution center for over 22 years.

RESEARCH TRIANGLE PARK, NC
This 32,000 sqft drug product manufacturing facility includes isolator manufacturing capabilities for liquid syringes, liquid and lyophilized vials, and is FDA and DEA compliant.

Sterile Fill Finish Manufacturing Core Capabilities:
Sterile solutions, suspensions, emulsions, and lyophilized drug product
Aseptic filling lines with isolator technology for filling liquid and lyophilized vials and pre-filled syringes
Terminal sterilization for vials
On site laboratory services specializing in biologics and small molecule testing
Storage temperatures: -80°C, -20°C, 5°C, controlled room temperature (CRT)
Lyophilization cycle and formulation development
Development and manufacturing of DEA Schedule I-V products
FDA, EMA, MHRA, PDMA and cGMP compliant

Summary

Alcami offers full-spectrum sterile fill finish manufacturing services for liquid and lyophilized injectable drugs. With decades of experience, we provide end-to-end solutions from preclinical development to commercial launch. Our state-of-the-art facilities in Charleston, SC and Research Triangle Park, NC are equipped to handle complex drug products, including suspensions, emulsions, and controlled substances. Alcami’s expertise ensures product quality, compliance, and scalability.

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Your product is unique.

You deserve a unique CDMO.

Contact Alcami