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Expertise
Our Leadership team has extensive collective experience in steering products from pre-clinical to commercial manufacture.
Science-led
Our approach is scientific, collaborative and open, ensuring an open dialogue and transparency that fits your project.
Award-winning
We are a leading CDMO recognised for numerous awards including a King's Award For Enterprise.
Nimble
We adapt to your project needs, and pledge to never relegating it to the bottom of the list.
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 sterile facility
A new purpose-built 7,000sqft facility, designed specifically in line with the revised EU GMP Annex-1 regulations is due to be operational in Q1 2025.
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.
Our sterile capabilities at a glance
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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).
– Aseptically prepared lyophilized and spray dried powders.
Expertise you can trust
Our Leadership Team excels in steering products from pre-clinical to market. This extensive expertise forms the cornerstone of our service to you, ensuring hands-on involvement at every stage and every level of our business.
Full-service offering
Alongside our upcoming aseptic capabilities, our formulation development across a broad range of dosage forms, clinical trial supply, and niche-scale commercial manufacturing for non-sterile dosage forms provides accessible scale-up and unparalleled project delivery.
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.
Frequently Asked Questions
What are your sterile fill/finish capabilities?
- Formulation development and stability testing
- Aseptic preparation and terminally sterilized products
- Batch sizes up to 2,000 units
- Filling of vials and pre-filled syringes
- CMC sterility assurance package
