During the drug development process, non-GMP processing or manufacturing may be employed at certain development stages to save time and reduce costs. For example, this applies to pilot or small-scale production for process testing or toxicological studies. Leukocare offers aseptic fill and finish services for pharmaceutical products in small batches, specifically for non-clinical toxicological studies (tox studies). The drug product can be filled into vials, bags, syringes, or other containers in various formats, including liquid, liquid-frozen, freeze-dried, or spray-dried.

We support process transfer for freeze drying and offer additional services such as buffer exchange, up-concentration, and ultrafiltration/diafiltration (UF/DF), covering volumes from approximately 1 to 500 mL. We also provide compounding of drug substances with excipients, as well as excipient-only formulations for vehicles or placebos. In addition, we offer aseptic filling for non-clinical tox studies for Biosafety Level 2 (BSL-2) materials.