BAG offers a full range of services to deliver highest quality with a focus on small to medium-sized batches. Our services include:
Fill and finish
BAG provides complete fill and finish services for aseptically prefilled vials and ampoules, both liquid and lyophilized. This includes analytical and microbiological testing and 100% visual inspection, complying with all GMP standards.
BAG tests incoming raw materials and performs in-process controls and finished drug product testing. All utilities, cleanrooms, and processes are routinely monitored according to GMP requirements.
BAG offers expertise in both small molecules and complex, sensitive compounds such as biologics. BAG has experience in the successful fill and finish manufacturing of many classes of compounds, including monoclonal antibodies, peptides, proteins, low-molecular-weight heparins, interferons, oligonucleotides, vaccines (non-live), enzymes, human growth hormones, interleukins, and coagulation factors.
Filling capacity and systems
BAG can produce a variety of batch sizes:
- Vials (liquid) up to 50,000 / batch
- Vials (lyophilized) up to 70,000 / batch
- Ampoules (liquid) up to 50,000 / batch
- Ampoules (lyophilized) up to 31,000 / batch
Full compliant GMP facility, all functions together at a single location
- HPW and WFI are manufactured, controlled and stored on site
- Two washing machines for primary packaging material available
- One filling line with continuous process (Washing, Sterilizing, Filling at once)
- Two filling lines with discontinuous process (Washing, Sterilizing, Filling process not at once)
- Three freeze dryers with different shelf-sizes (2x 3,6m² and 1x17,2m²) for flexible batch sizes
- Two ampoule filling and sealing machines
- Two vial filling and crimping machines
- Compounding of bulk solution at clean room grade C with Laminar Flow Protection
- Sterile filtration with nitrogen or via peristaltic pump possible
- Aseptic filling in clean rooms grade A obtained by laminar flow units
- UV protection in compounding and filling areas
- Flexible tube connections for filtration and filling operations, meaning less losses and flexibility for materials