Non-GMP Processing & Small Scale Manufacturing
Extensive experience
Short timelines
Customized processing
Leukocare offers fill and finish services of pharmaceutical products in small batches under clean conditions for non-clinical studies (tox studies). The drug products can be filled in vials, bags, syringes or other containers in various formats such as liquid, liquid-frozen, or freeze-dried. We can support the process transfer for freeze drying, offer buffer exchange, up-concentration, ultrafiltration/diafiltration (UF/DF) covering volumes from approx. 1 – 500 mL and compounding of drug substances plus excipients as well as excipients only for vehicles/ placebos. We are able to perform semi-automated filling of high concentration formulations with high recovery and minimum losses. This potential allows us to identify the most stabilizing excipients and develop the best formulations. We offer filling for non-clinical tox studies also at Biosafety Level 2 (BSL-2).
- Simultaneous re-buffering of up to 24 formulations
- Suitable for membrane screening
- Integrated in-process control
- Development of scalable process
- Multiple adjustable parameters
- Vial filling services
- Process development
- Lyophilization services
- Process development
- Spray-drying services