Angel Biotechnology - Contract Biomanufacturing

Angel Biotechnology Holdings (AIM: ABH) is a world class, contract biomanufacturing company offering process development services and pre-GMP and cGMP manufacturing to support biotechnology and pharmaceutical companies worldwide.

Angel's principal activity is the manufacture and supply of materials for use in early stage drug development and pre-clinical studies, along with drug product and CMC documentation for phases I, II and III clinical trials and the manufacture of licensed drugs or vaccines.

Angel is managed by a team that has more than 100 years' combined experience in pharmaceutical and biopharmaceutical manufacture, gained in companies such as Glaxo and Serologicals.

Process development services and pre-GMP and cGMP manufacturing

Angel operates out of Pentlands Science Park, near Edinburgh. The facilities at Pentlands Science Park include fermenters for cGMP production of materials using mammalian cells and for production of material using bacteria, fungi or yeast under cGMP conditions.

By combining specialist molecular biology skills to develop efficient and robust strains and cell lines, with a combination of different fermenter types and sizes, Angel are able to efficiently manufacture a wide range of biopharmaceuticals in quantities ranging from pilot scale through to the quantities required to support phase III studies.

Recombinant proteins, cellular therapies, antibodies and viruses

Angel Biotechnology makes available the combined expertise of its technical and management teams to plan and execute manufacturing strategies for recombinant proteins, cellular therapies and stem cells, antibodies, and viruses.

Our manufacturing services include:

• cGMP manufacture in microbial and mammalian systems
• Genetic modification
• Fast process development and scale-up
• Fermentation and cell culture medium and process optimization
• Transfer to animal component free media and media optimization
• Assay development
• Strain development to ensure the optimum design and selection of the producer cell strain
• Comprehensive down stream processing services
• Cell banking
• Stability studies
• CMC documentation package and IND support

With a highly experienced team we can help you to develop a strategy based upon a sound understanding of regulatory requirements, offering value added services that can be used to optimise the production process.

Project management for cGMP manufacturing

The role of project management is introduced to our clients early on during commercial discussions to emphasize the importance the company places on client communication and our ability to meet quality objectives, whilst completing the project on time.

On contract agreement, a project manager is appointed as the main contact and coordinator for the project. The project manager is responsible for delivering the programme to client specifications and achieves this with the support of technical leaders and their dedicated development and cGMP manufacturing teams.

A strategic steering group comprised of client and senior Angel personnel acts as an advisory board to the technical team, provides an oversight on the progress of a project and approves change.

Quality assurance and regulatory compliance

Angel Biotechnology is totally committed to quality, current good manufacturing practice (cGMP), customer service and continuous quality improvement. The company has a dedicated quality unit which monitors all aspects of quality and cGMP development and manufacture, including qualified person (QP) certification of product.

The company has a quality management system to meet the requirements of good manufacturing practice (2003/94/EC) for the manufacture of clinical trial supplies and also operates under ICHQ7a for the manufacture of active pharmaceutical ingredients.

The Pentlands Production Facility is Medicines and Healthcare Products Regulatory Agency (MHRA) approved under directive 2001/20/EC for the manufacture of investigational medicinal products (IMPs).

This licence gives authority for the manufacture of biological active substances under contract for EU clinical trials demonstrating compliance in accordance with the European Union (EU) Clinical Trials Directive. The licence also includes manufacture of cellular therapies and stem cells.

As well as having a license from the MHRA, the facility at Pentlands Science Park is licensed by the Human Tissue Authority (the HTA) which regulates the storage, use and disposal of human tissue in the UK.