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With extensive experience in aseptic processing and sterile manufacturing, our team can support you with aseptic and terminally sterilized small volume liquids for parenteral, ocular and pulmonary delivery.
Purpose-built facility
A new purpose-built 7,000sqft facility, designed specifically in line with the revised EU GMP Annex-1 regulations is due to be completed in Q4 2024.
The state-of-the-art build provides a new service to develop, manufacture, test and fill/finish sterile drug products for biologics and small molecules.
Alongside existing full-service formulation development and quality control labs our team can support your drug development with expertise and speed.
Sterile fill/finish services
Our contract manufacturing capabilities and successful regulatory history supports you in maximising the success of your drug product.
Our sterile processing capabilities include:
– Sterile drug products – aseptically prepared and terminally sterilised.
– Liquid formulations for parenteral, ocular and pulmonary delivery.
– Wide range of molecules from small molecules to Biologics (including proteins, peptides and mAbs).
– Small-scale batch sizes.
Product testing
Our team supports you in every aspect of analytical and microbial testing including the QP release of your final product.
We work to ensure the early identification of lead prototype formulations suitable for clinical testing followed by the development of your product through the product cycle.
Through ASAPprime® our teams generate robust, accelerated stability data, from API drug substance stability to formulation development prototypes and final dosage forms.
