SubscribeCustom Manufacturing Services: Taking a concept from the bench through to material for clinical trial is challenging.
This is where our 50 years of experience in process development and scale up can assist biotechnology companies to develop new therapeutic products. With a proven track record of developing in-house and customer products including enzymes, therapeutic proteins and vaccines, we can offer a flexible service designed to meet your needs.
Quality Assured
Our Quality and Regulatory Affairs staff work closely with customers throughout their projects ensuring all compliance issues are addressed and relevant regulatory requirements met. Our Porton Down site has a number of licensed facilities for the production of material to GMP standards and has been inspected by various international regulatory bodies. An overarching quality management system is in operation and the site is registered ISO 9001 (2000) compliant.
Step by Step
The Agency can undertake any or all stages of a process development and manufacturing project, working in partnership with the customer from initial concept through to finished and approved product produced to the highest standards in our licensed facilities.
Our range of services for natural and recombinant products include:
- A high yielding bacterial expression system
- Bacterial cell banking
- Growth media development and yield optimisation
- Fermentation scale up
- Purification and down stream processing
- GMP and non GMP production
- Bio-containment facilities
- Aseptic fill and finish
Process Development
Bacterial Cell Banking, Scale up and Optimisation
The organisation has a wealth of experience in extracting, isolating and purifying products from both native and recombinant organisms, including those requiring containment. Our proven track record enables us to design and optimise procedures that will maximise product recovery and integrity.
Having a seed culture of known provenance is a prerequisite for biotechnology products destined for clinical trials and we can produce master and working bacterial cell banks in GMP compliant facilities as part of an overall development package.
Growth media development and yield optimisation is undertaken in our newly upgraded process development suite that has a range of state-of-the-art laboratory scale fermenters. Pilot-scale facilities for process development and scale up include 25L and 200L bioreactors. The site also has a series of vessels from 10L which can operate under appropriate levels of containment for the production of products from high-risk pathogens.
Once a process has been optimised, we are able to offer a seamless transfer into GMP-compliant manufacturing facilities.
GMP Manufacture
HPA offers a range of facilities for GMP manufacture of biopharmaceutical products for clinical trial purposes and market. Manufacture is supported by QC and QA capabilities that ensure fully documented procedures to appropriate regulatory standards.
Fermentation and Product Recovery
Our licensed GMP fermentation facility features bacterial fermentation vessels from 25L to 750L and product recovery equipment including continuous centrifuges and crossflow filtration, enabling us to be flexible in response to our customers' needs. A process control system for the bioreactors provides the ability to control the systems to a high degree of accuracy, ensuring the necessary auditing, control and support to ensure regulatory compliance.
A separate licensed facility is designed to provide containment at Containment Level 3 with dedicated air handling effluent treatment for the manufacture of specialist products, including those for the emerging biodefence and emergency vaccine sectors.
Downstream Processing and Fill/Finish
Our capability for purification of products enables us to provide parallel handling of different products in segregated areas with a variety of stainless steel vessels, chromatography columns and other purification equipment.
The aseptic product finishing suite has filling and freeze drying capabilities and is due to be upgraded during 2005. This will increase our filling capacity, enabling the organisation to meet its projected workload, whilst maintaining the flexibility to undertake specific contract filling operations for customers.