Angel Biotechnology (AIM: ABH) is a world-class, contract biomanufacturing company offering process development, pre-GMP and cGMP manufacturing services to a wide range of companies from small start-ups and spin-outs to international biotechnology and pharmaceutical companies. The Company specialises in the development and manufacture of advanced biologics for clinical trial use and commercial sale.

Angel Biotechnology offers the following services:

• cGMP manufacture of advanced biologics in both microbial and mammalian systems;
• process development and scale-up;
• transfer to animal component-free media and media optimisation;
• assay development;
• strain development to ensure the optimum design and selection of the producer cell strain;
• comprehensive GMP compliant protein purification services;
• cell/strain banking;
• stability studies;
• support with regulatory authorities; and
• CMC documentation package and IND support.

Angel is totally committed to quality, current Good Manufacturing Practice (cGMP), continuous quality improvement, client satisfaction and the maintaining appropriate accreditation.

Angel is accredited by Medicines and Healthcare products Regulatory Agency (MHRA) with the following licences:

Investigational Medicinal Products (MIA IMP)

Manufacturers’/Importers’ Licence (MIA)

The Company has a quality management system to meet the requirements of GMP (2003/94/EC) and also operates under ICHQ7 for the GMP of Active Pharmaceutical Ingredients.

Angel has a dedicated independent quality unit (qualified person, quality assurance and quality control) which monitors all aspects of quality management system to support development, cGMP manufacture and testing.

Our quality management system is constantly evolving as regulations, methods and test procedures are updated and regulatory/client inspection recommendations are instigated. Angel Biotechnology is proud of the level of quality recognition by both industry and authority and passes these benefits on to its customers by way of delivering a quality service.

Our quality management system details the following functions to ensure complete control of all of our cGMP activities:

• self inspections and audits;
• suppliers and sub-contractors evaluations;
• standard operating orocedure control, technical transfer protocols and reports, development plans and reports, batch manufacturing records, specifications & site master file maintenance;
• maintaining change control;
• deviations; and
• continual review of the auality management system.

Angel’s quality management system involves the active participation of the management and personnel of all departments. This rigorous attention to quality and detail has been critical to the delivery of successful projects.

Quality control performs testing to cGMP, following international regulatory guidelines within a dedicated laboratory. They perform the following activities:

• assay validations performed to ICH Guidelines Q2;
• testing of starting materials and intermediate and final products;
  • includes rapid assays necessary for parametric release purposes; and
• stability testing.

Quality control testing

• Analytical testing to Ph. Eur and USP includes:
  • HPLC;
  • protein content determination;
  • ELISA;
  • electrophoresis techniques (SDS PAGE, IEF and western blot);
  • appearance; and
  • pH/conductivity determination.

• Microbial testing includes
  • total viable counts;
  • rapid endotoxin; and
  • rapid mycoplasma.

Angel has close working relationships with MHRA accredited contract laboratories which allow them to offer a wide range of assays.

There is also continual quality control presence within Angel’s GMP manufacturing facility.

QP Certification

Angel can provide certification by a qualified person (QP) and batch release within the European Community (EC) or European Economic Area (EEA) to the relevant legislative requirements detailed in Directive 2001/83/EC and 2001/82/EC.

 

Our project management team ensures all projects are delivered on time, within budget and to the highest quality standards. The project managers ensure clear communication throughout the project between you, our customer and the dedicated Angel technical teams. 

Our project managers will manage your programmes from initiation, through planning and execution to close out, including:

• primary point of contact;
• early identification of project risks;
• contingency and scenario planning;
• managing changes to the project scope;
• resource management;
• effective communication tailored to suit client requirements;
• ensuring the project team are focused on a common set of objectives;
• ensuring project objectives and deliverables are met on time and in full; and
• managing the progression of the project.