The course is spread over two days to allow interaction between the lecturer and attendees. The presentations will be supplemented with workshops that will be used to verify understanding and look at the biotechnology industry and its future. The course itself will encourage discussion and participation which will lead to greater understanding of the current status of biotechnology and the future of the industry.

Course objectives are to provide an understanding of:

• Different types of biotechnology processes
• Current and future GMP requirements for biotechnology
• Typical product lifecycle phases and regulatory requirements
• Steps involved in the manufacture of clinical batches including scale up, product characterisation, and control of process inputs and outputs
• How the product can influence facility design and the use of disposable technologies
• Differences between the production of a variety of cell substrates e.g. mammalian, bacterial, viral, and plant cell products
• Upstream processing including cell culture, fermentation, harvest
• Downstream processing including typical purification techniques
• Analytical techniques employed to verify final product purity
• Fill Finish activities, storage and distribution of product
• Principles of process and equipment validation

This course will include presentations and workshop sessions on the following subject areas:

Day 1

cGMP in Biotechnology: An introduction to the cGMP aspects of biotechnology management and control. This session will review the standard commonalities and also the specific differences and activities within biotechnology that require a re-think of the standard GMP attitudes. We will look at anticipated and future requirements together with observations given by inspectors.

Regulations and Standards: This session will include a review of EU Annex 2, ICH Q5A/B/C/D/E, FDA requirements, Licensing and Development.

Biotech Products 1: What is a biotech product and how has the perception of biotechnology changed over the years? How do the different types of biotech products work and what are the different methods of presentation and delivery?

Biotech Products 2: What are the various forms of biotech products in the current pharmaceutical environment? The presentation includes an outline of different types and a review of current standing of each type in the pharmaceutical industry.

Clinical Batches: Within this session the application of scale-up, product characterisation, raw material usage, and control of plant, animal, viral and bacterial derived products will be reviewed.

Facility structure and organisation for Biotech Production: An overview of the risks and controls required when constructing a biotech facility together with the use and benefits (or otherwise) of disposable technology will be provided.

Day 2

Upstream Processing: This session will review the processes involved in preparation and initial generation of material for production of crude biotech products prior to purification.

Downstream Processing: The session will review the confirmation of production and primary and secondary purification requirements and techniques together with in-process activities.

Analytical Techniques: What analytical techniques and testing are required to confirm that the final product is of the purity and definition required. A range of analytical techniques will be reviewed including absence of viruses, DNA and plasmid confirmation plus purity and stability checks.

Fill-finish and Storage/Distribution: There will be a review of formulation and fill/finish into final containers, controls required and the storage and distribution of the final product, including requirements in the hospital or clinic.

Validation 1: A review of the validation, qualification requirements and techniques for the process, CQA/CCP, media production and hold times plus cleaning.

Validation 2: An overview of the validation and qualification requirements for equipment used, virus filtration and overall IQ/OQ/PQ practices and documentation.

Please note: Our online booking system works in £GBP.

Honeyman reserves the right to amend any prices at any time. All advertised prices are exclusive of any applicable VAT or local taxes.

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