Commercial Drug Manufacturing for Tough Aseptic Projects

Built for the complex, we deliver commercial drug product manufacturing for parenteral products that demand precision. From potent compounds to sensitive formulations, we offer cGMP-certified quality, seamless tech transfer, batch scalability, and full regulatory support.

Let’s Take Your Product to Market

About Our Commercial Drug Manufacturing

Benefits

Capabilities

Team up with Pii for

Full cGMP Compliance: Sterile, safe, and always on-point. Your parenteral products deserve nothing less from commercial drug manufacturing.
Mastery of the Complex: High-potency compounds, cytotoxics, or DEA-controlled substances? We handle what others can’t.
Precision Meets Speed: Robotic filling lines, advanced lyophilization, and terminal sterilization ensure every dose is ready.
Seamless Tech Transfer: From development to commercial scale without the headaches.

Whatever you need, exactly when you need it. Our end-to-end commercial drug manufacturing capabilities include

Filling Solutions: Vial, syringe, and cartridge filling with batch sizes from 1L to 1000L.
Integrated Processes: Advanced lyophilization with Millrock systems and terminal sterilization for maximum product safety.
End-to-End Solutions: Including formulation, manufacturing, commercial packaging (unit and case), product insert, serialization.
Regulatory Expertise: Support for NDAs, ANDAs, NADAs, and ANADAs, seamless site transfers to U.S.-based facilities, and 503B compounding.

Sterility You Can Trust, Quality You Deserve

We combine FDA-inspected, GMP-certified facilities with a proven team to guarantee your product’s safety. From contamination prevention to QbD principles, our commercial drug manufacturing is designed to protect patients and deliver results.

Our Quality Assurance

2 FEIs for oral dose and aseptic manufacturing.

60+ Commercial products launched

70+ GMP suites and 30,000 sq. ft. of warehousing space.

DEA-controlled substances, cold storage, and hormone facilities.

90%

of clients agree we delivered effective solutions

100%

FDA license to produce commercial products

30+

years of experience in commercial drug manufacturing

The Projects We Love

Bring us your toughest projects. We thrive on challenges like

Complex Formulations: Highly viscous solutions, potent compounds, and sensitive molecules.
Specialized Products: Orphan drugs, inclusion complexes, dispersed systems, and AB-rated generics.
Innovative Needs: Emulsions, suspensions, micelles, liposomes, and polymeric particles.

High Precision Aseptic Filling

Precision, no compromises. Our 4 robotic filling lines, including Groninger DFVN 1000 and AST GENiSYS^Ⓡ R20, deliver aseptic manufacturing for a wide range of batch sizes.

Groninger DFVN 1000

AST GENiSYS® R20

Robotic Aseptic Fill-Finish

Maximize drug product yield with high-speed vial filling at scale.

Our robotic filling lines

AST GENiSYS^Ⓡ R20
Groninger DFVN 1000
Bosch
M&O Perry

Designed to minimize contamination in aseptic commercial drug manufacturing, our systems handle vials, syringes, and cartridges with accuracy and efficiency.

From high-speed Bosch filling to advanced lyophilization integration, we ensure every batch meets the highest standards.

A high-speed vial filling robotic aseptic commercial drug manufacturing fill-finish line.

Got questions?

We have the answers! Transparency is our foundation. Reach out—we’re always happy to tackle your complex and unique aseptic needs.

Let’s Talk

Effortless Tech Transfer

Since 2009, we have made tech transfer seamless for aseptic commercial drug manufacturing. We start by understanding every detail of your product and ensuring a smooth, no-surprise transition to our GMP-certified facilities.

From high potency to synthetic particles requiring meticulous regulatory compliance, we tackle complex formulations head-on. Count on precision handling and full regulatory support to bring your drug product to commercial success—delivered with the quality and consistency it deserves.