Manufacturing Services
August Bioservices supports a wide range of cGMP manufacturing programs, spanning a variety of container types, and fill volumes. 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.
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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
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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
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Prefilled syringes
- 0.5 mL to 10 mL fill
- Glass or polymer syringes
- Mid-scale syringe filler and Optima isolated high-speed filler
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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
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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
IMA vial labeling
Stevanato Plus 400
Korber MS-S
DIVADELLA - NEOTOP X
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