Biotechnology: Principles in Practice®
: 21 Nov 2019 - 22 Nov 2019
: Barnard Castle, United Kingdom
Type: Training, Seminar
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.
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.