Manufacturing Services

We serve a diverse portfolio of client projects including small & large molecules, aseptic and terminally sterilized products, and clinical to commercial phase manufacturing.

Quality, safety, and efficiency by design

Multiple clean rooms, formulation suites, and filling lines

• Formulation scale from 1 L to 4000 L
• Fully isolated filling for vials, syringes, and IV bags
• Automated visual inspection, assembly, labeling, packaging, and serialization
• On-site warehouse, cold room, and DEA schedule III-V storage

Diverse formulation capabilities

Our formulation suites are designed for flexibility, supporting a wide range of sterile drug products across all phases of development and manufacturing. With both stainless steel and single-use technologies, we offer scalable solutions tailored to client requirements.

Single-use formulation

• 20 L to 1000 L capacity
• High-performance, rapid and low shear mixing
• Sterile, ready-to-use product contact surfaces
• Integrated monitoring
• Temperature controlled

Stainless steel formulation

• 1 L to 4000 L capacity
• Automated clean-in-place, sterilize-in-place, and dry-in-place
• Integrated magnetic, upstream, and high shear mixers
• Aseptic formulation compatibility
• Integrated monitoring
• Temperature controlled

Sterile filling at every scale

Isolated filling lines for aseptic or terminally sterilized vials, syringes, and IV bags. Seven filling lines for a wide range of container types, sizes, and batch sizes

Prefilled syringes

• 0.5 mL to 10 mL fill
• Glass or polymer syringes
• Mid-scale syringe filler and Optima isolated high-speed filler

Vials

• 0.2 mL to 100 mL fill
• Fully isolated filling lines for batches of any size
• Isolated small-scale vial filler, mid-scale vial filler, and Optima isolated high-speed vial filler

IV bags

• 50 mL to 2 L fill
• Both terminally sterilized and isolated aseptic bag fillers
• Expertise in film selection and bag design

End-of-line automation

Automated inspection, assembly, labeling, packaging, and serialization capabilities ensure precision, speed, and compliance—streamlining the path from production to market with built-in quality and traceability

Automation

• High-speed, fully automated inspection for vials and syringes
• Automated vial labeling and syringe assembly and labeling
• Automated cartoning with check weigh system for box content post-cartoning
• Case packing with two tamper evident applications and multi-step verification pellet aggregation
• Automated serialization with laser/inkjet 2D matrix, lot, and expiry

Clinical and commercial storage and distribution

Multi-condition on-site storage capabilities, including cold storage for raw materials, work-in-progress, and finished goods

• Controlled temperature storage and distribution from 25˚C to -80˚C
• DEA Schedule III-V storage