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ECA - Barrier Systems - Live Online
Barrier Systems (16. September 2020)
This is why you will benefi t from attending this conference:
Case studies from various pharmaceutical companies will deal with the implementation, qualifi cation
and operation of Isolator and RABS systems.
- You will discuss the current state of the art and new technological developments in Barrier Systems
- You will get to know fi rst hand the new EU-GMP Annex 1 draft requirements on Barrier Systems
- Experts from pharmaceutical companies will share their knowledge regarding operational experience.
The protection against microbial contamination is the most important point for drugs produced by aseptic
processes. Today the regulators require a more strict separation between operators and product in the
form of an access barrier.
Two systems are on the market – RABS (Restricted Access Barrier System) and Isolators. But only isolators
are referred to by the US FDA as advanced aseptic technology.
This conference will focus on current questions of barrier systems coming from FDA regulations as well as
from the revised EU-GMP Annex 1, and it will specifi cally address the subject from the perspectives of pharmaceutical operators, planners and engineers.
Didier Meyer, DMCompliance
This event is directed at decision-makers from pharmaceutical production, development and quality assurance/
control. It also addresses engineers and planners who need to be well informed about current
developments in the fi eld of barrier systems.
Case Study AbbVie: The new Biologics Site in Singapore
Dr. Rolf Ratke, Abbvie
Ronan Mc Garvey, Abbvie
- The Site strategy
- Products, processes & equipment
- Cooperation with EMA, blueprint to prepare for the successful pre-approval-inspection
- From start- up to realization until approval
From design to construction of a new integrated ll & nish facility – combination of proven
and new technologies
Dr. Gabriele Sabine Roidl, Lonza
- Installation of a new drug production line
- Using modern and innovative technologies
- Vial filling line with isolator technology and 2 lyophilizers
Aseptic processing and filling of a viral vector for gene and cell therapy
Leslie Southam, Oxford Biomedica
James Drinkwater, Franz Ziel
- An integrated solution of a state of the art small batch filler in a barrier system, designed to fit a biological production process: Freeze/thaw and time restrictions of the product lead to a special line layout where formulation and filling are combined in one barrier system
- Application of No-touch-transfer (NTT): An alternative methodology to introduce pre-sterilized product containers into the Grade A environment without in process disinfection steps
- Aseptic Containment Approach: Requirements on containment driven by cross contamination control are combined with requirements for aseptic filling and viral containment
Barrier Systems and Annex 1: GMP inspectors’s point of view
Dr. Daniel Müller, Local GMP Authority of Baden-Württemberg
- Most important changes of Annex 1 – an update
- Regulatory comparison of Annex 1 version 2018 and new / intended Annex 1
- GMP inspector’s comments on new / intended requirements for barriers
Nanovectors to Enhanced Biodisponibility
Franck Pavan, V Nano
- Theory on nanoformulation explaining top down and bottom up processes
- Comparison of technologies
- Scale up constraints in Non GMP Environment
- Scale up constraints in GMP environment
- Scalability of processes
- QC Characterization of molecules
- Commercial production impacts on facility and equipment
- Case study
Vaccines for the World - Insights into Design and Execution of a BSL2 Fill-Finish Facility
Rutger Vandiest, Bavarian Nordic
Mark Miller, IPS
- The fill & finish operations for viral vaccines: specific attributes to facility and equipment
- Design, construction and qualification of their new fill & finish facility in Denmark
- Filling and lyophilization of live vaccines in a BSL2 environment
- Dedicated capacity for CDMO services
Writing User Requirement Specifications (URS) for Isolator projects
Dr. Timo Krebsbach, HHAC Labor Dr. Heusler
- The URS should define clearly and precisely, what the user wants the equipment to do in terms of performance characteristics, product quality metrics, and production yields. It should also define any nonfunctional requirements, constraints, and deliverables that need to be supplied with the system.
- The presentation shows the lesson learned from the view of a customer.
- In the future topics like automation and digitalization need more attention from the very beginning