Course No 9348
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Dr Robert Eskes
Dr Volker Öppling
PEI, German Federal Institut for Vaccines and Biomedicines
Dr Andreas Neubert
Mag. Petra Falb
AGES - Austrian Agency for Health and Food Safety
Baxter AG, Austria
Dr Jörg Weyermann
The development and production of vaccines makes high demands on the manufacturing pharmaceutical industry. The special requirements on handling and safety with live organisms necessitate measures which exceed the requirements of classic pharmaceutical manufacturing.
Topics like the enhanced risk of cross-contaminations, questions about individual safety of staff and the issues of cleaning and disinfection of rooms and equipment concern a vaccine manufacturer in a considerable scale.
Specifically the demands of the necessary bio safety classes with negative pressure of rooms versus that of aseptic processing with positive pressure requires a well thought- out design of vaccine facilities.
Also, the safety of environment and waste disposal should receive proper attention already in the design phase. But the dedicated requirements on staff safety are also a challenge in vaccine manufacturing
This Course will give you the possibility to see the theoretical background as well as the practical implementation of GMP requirements in the vaccine production. A combination of theoretical requirements and practical case studies is the best way to learn this.
Speakers from regulatory bodies, consulting and practising experts will give you the chance to get to know the different views and you will have ample opportunity to discuss with speakers and other participants about specific issues.
“Vaccines are expected to be very safe” is one of the headlines in the presentation of the CBER “Vaccine safety team”. At the same time, new vaccines are needed for diseases for which currently no vaccine is available, and production technologies need improvement to deal with the shortage of certain types of vaccines. This has led to the emergence of new technologies. One of the important questions from the authorities however is “How safe are the new technologies”. The FDA has issued a draft guideline on new cell substrates for vaccine manufacturing to detail requirements in this area.
In the development of new technologies for the pharmaceutical and biopharmaceutical production of vaccines again the question of GMP compliance and safety is emphasised.
Furthermore, with the Quality Initiative for the 21st Century from the FDA new guidelines have been issued, which have an impact not just on the conventional pharmaceutical industry but also on vaccine manufacturers. Risk management and quality in design are essential in the implementation of new technologies and the introduction of new vaccines. Ensuring the expected safety is one of the greatest challenges of all vaccine producers.
The course is designed for personnel of pharmaceutical industries, their suppliers and regulatory bodies who
are responsible for quality control and/or quality
assurance in vaccine/biopharmaceutical production
manage the vaccine production
establish the operator protection
audit vaccine manufacturers
design or operate vaccine production sites
GMP for vaccines: What are the issues?
Differences between vaccines and conventional products
Inactivated and live vaccines
Control of vaccine strains and cell lines
Risk of (cross-)contamination
The Peculiarities of Bacterial Vaccines
Types of vaccines available
Manufacturing of classical/modern bacterial vaccines
Challenges in manufacturing (quality/regulatory issues)
New technologies and products
The Peculiarities of Viral Vaccines from viral seeds to finished products
Requirements for raw and starting materials
Efficient process and product control
Setting specifications adequately
Appropriate tests and assays for product release
Viral safety aspects
How to deal with OOS results?
Requirements for early and late clinical trial phases
Containment, Biological Safety and Product Protection
Containment, product safety versus environmental safety
Primary containment and additional measures
Negative pressure areas in aseptic manufacturing
Decontamination of facilities
Personnel as critical component in containment
Case Study: New building of a multipurpose vaccine production facility
Practical issues with flow of material, personnel and waste material
Clean room qualification
Segregation of cell preparation, virus production and downstream processing
Change over procedures for manufacturing campaigns
Case Study: Different Fogging and Gassing Systems for decontamination of Isolators, Lyophilizisers and Clean Rooms
Different gassing systems
Validation of a dry fog detergent
Issues of Staff Safety
Requirements and Guidelines
Differences Vaccines Products and Plasma Products
Use of S3 Coveralls
Environmental Health and Safety challenges
Examples from daily business
Decontamination, virus inactivation and virus removal techniques
Decontamination of surfaces
Validation of decontamination procedures
Virus inactivation: principles and methods
Virus removal methods
GMP issues on virus inactivation and virus removal techniques
cGMP Issues for Upstream Processing
General GMP concerns for upstream processing
Raw materials and media preparation
Inactivation of microorganisms
GMP manufacturing of recombinant viral vaccines for clinical trials
Regulatory expectations for vaccine batches for phase 1/2/3 clinical trials
Development vs. validation
Regulatory expectations for implementation of analytical methods – qualification and validation
Contract manufacturing of IMPD´s
cGMP Issues for Downstream Processing
General GMP concerns for downstream processing
Sterile filtration and aseptic processing
Case Study: Planning and Realization of a new filling facility in direct cooperation with existing bulk
Requirements of design
Issues of construction