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Biopharmaceutical Product & Clinical Development (BS973)

Introduction

The primary aim of this module is to provide a knowledge base relevant to the development and exploitation of new
bio-products by the pharmaceutical industry. It will seek to ensure integrating of the information presented with the core ethos of the programme by addressing issues concerned with the conversion of an idea in bio-science into a commercial reality.

 

Content

What is a biopharmaceutical?

Development of a biopharmaceutical.

Regulatory Agencies, policies and guidelines.

Chemistry, Manufacture and Control (CMC).

Cell substrates.

Manufacture.

Process validation and qualification.

Control of viral contamination.

Good Manufacturing Practice and Quality Assurance.

Batch to batch release – quality, purity, potency.

Vaccines.

Clinical trials and marketing in Europe, USA and Canada.

International markets.

Regulatory Agency interactions.

Regulatory Agency inspections.

Contract companies; partnerships.

Clinical stages vs marketing.

New technologies.

Biogenerics.