Development Capabilities

Complementing its core technologies and discovery expertise, MedImmune Cambridge has an excellent in-house team of drug development professionals who have demonstrated the Company's ability to develop human monoclonal antibody therapeutic candidates through all stages of preclinical and clinical development.

• Biopharmaceutical Production
• Regulatory Affairs
• Clinical Development
• Management of Contractors and Consultants
• Lonza Biologics

Biopharmaceutical Production

It is essential that every antibody identified by CAT as a potential therapeutic candidate against a chosen antigen target, can be manufactured in sufficient quantities for use in discovery, clinical trials and ultimately, commercial purposes. Therefore every antibody drug candidate is designed to be compatible with the production processes at MedImmune Cambridge; with yield, purity and targeted costs of goods built into the development plan. Our biopharmaceutical production function also ensures quality and consistency in the outcome of all its production processes.

In-house Manufacture: We can produce sufficient quantities of human monoclonal antibody materials to meet all development needs prior to commencing clinical trials.

Primary Manufacture: We have developed mammalian cell line cultures and manufacturing processes which are used by its external contractor, Lonza Biologics, to carry out large-scale GMP culture and purification to provide significant quantities of human monoclonal antibody material for use in clinical trials, compliant with the current regulatory guidelines.

Formulation: We have developed antibody formulation expertise and designs formulations that are stable and meet the needs of clinical development.

Secondary Manufacture: contractors dispense the human monoclonal antibodies into sterile vials for storage and prior to administration.

Other developmental capabilities:

• Bioanalytical Assay Development: We have a bioanalytical assay group that develops specialised assays (to measure pharmacokinetics, immunogenicity and biomarkers) in support of its clinical trials. We have considerable expertise in this area of development of human monoclonal antibodies.
• Product Characterisation: We have developed methods to analyse the complex chemical structure of human monoclonal antibody products at very high resolution, in accordance with current regulatory guidelines.

MedImmune Cambridge has GMP compliant Quality Control facilities and experienced Quality Assurance teams working in-house and with its contractors who ensure compliance with the latest GLP, GMP and GCP (= GXP) guidelines.
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Regulatory Affairs

For the in-house development of each of its human monoclonal antibody therapeutics, our regulatory affairs group is responsible for:

• capturing and managing CMC (chemistry, manufacturing and control) pre-clinical and clinical trial data and collating it for regulatory submission,
• presenting the data to, and obtaining clinical trial approvals from, individual agencies in the EU, US and internationally,
• interpreting legislation and guidance from the regulatory agencies in Europe and the FDA in the USA, and
• providing input to development programmes that will ultimately lead to regulatory approval.

In addition, we may be involved in some or all of the regulatory submissions for its collaborative programmes.
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Clinical Development

For the in-house development of each of its human monoclonal antibody therapeutics, the activities of our clinical research group include:

• defining early clinical development programmes,
• creating Investigators Brochures and liaising with KOLs, Clinical Investigators and other experts,
• design of clinical trials,
• selection and management of contractors responsible for the set up, initiation, monitoring, data analysis and reporting of clinical trials, and
• for the joint development of programmes with its collaborative partners, participating on steering committees.

Management of Contractors and Consultants

In some areas we operate in a "virtual" manner using external contractors and consultants to supplement resource and expertise. For example, we use contractors for GMP level primary and secondary manufacturing. In regulatory affairs, we extend our in-house expertise by using an external network of collaborators and locally based agents. In clinical development, we operate a virtual team of contractors and consultants responsible for the management of individual trials in the field, data analysis and reporting.

We have the expertise to effectively manage an external community of contractors and consultants throughout all development functions to meet its goals.
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Lonza Biologics

In 2001, CAT and Lonza Biologics entered into an agreement extended in 2004 in which Lonza Biologics will manufacture and supply clinical grade antibodies to CAT. The agreement guarantees that we have access to manufacturing capacity for ongoing and future projects and a reliable supply of antibodies for clinical trials. We work with Lonza Biologics to develop and refine efficient manufacturing processes to be used during production.
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