The agenda has been drafted to present case studies & testimonies from users with a solid industrial experience and who can provide a valuable feedback about the gains and the pains they encountered during some recent projects execution. The 3 topics we have selected for 2018 are:
Scale up, Scale down and Scale out
Purification & Chromatography
Our audience is coming from Process Dev, Manufacturing, Engineering & QA/Regulatory people. The 2 days program has been designed to provide a good balance between plenary lectures delivered by key opinion leaders, interactive workshops co-animated by a tandem of biotech users & trusted suppliers and direct interactions at the supplier’s booths. The multidisciplinary nature of the congress as well as the unique interactive atmosphere of all the A3P events, are creating THE real differentiating factors among other existing forum. Indeed, each congress section has been though to generate fruitful exchanges between speakers, animators, users, suppliers, experts, facilitators through panel’s discussions, interactive workshops, coffee breaks & lunch cocktails at the supplier booths.
Wednesday, June 27th
Biotech processes : shaping the future ?
Alain BERNARD - AB CONSULTING
mAb purification process intensification: evaluation of a fully-connected DSP process operated in flow-through mode
Nicolas LAROUDIE – MERCK
Coffee Break & Exhibition Time
Addressing the need for increased productivity in mAb downstream bioprocessing
Annika FORSS – GE Healthcare Life Sciences
Challenges and Advances in Cleaning Ultrafiltration membranes
Beth KROEGER – STERIS
Lunch in the exhibition
6 simultaneous workshops sessions throughout the afternoon, animated by ABCONSULTING, BOEHRINGER INGELHEIM, GSK VACCINES, LFB, MERCK, R-PHARM, SARTORIUS, SGS, SOURCIN, STERIS, THERMOFISHER
Registration to the workshop of your choice mandatory, find the summaries on the workshop tab
Cocktail in the exhibition
Thursday, June 28th
New approaches for Upstream scale-up transfer
Flavien THUET - MERCK
Scale down model: strategy for implementation - learning and feed back from a case study on adherent cells culture and viral culture with Poliovirus
A3P workshops gather during half a day a limited number of people around a defined subject with two specialists and an A3P moderator. Purpose: To allow the participants to this congress to work together for an initial or a deeper knowledge either upon a defined technical or a regulatory matter from a theoritical or a practical point of view.
The defined subject is mainly explained and explored through shared case studies.The results/solutions of these case studies lead to written conclusions. The two facilitators are specialists from theory and practice upon the subject of the workshop. Their pedagogic approach of the subject must avoid any commercial and/or marketing matter.
Workshops sessions - 27th June
Using the BPSA best practices guide “design, control, and monitoring of single-use systems (SUS) for integrity assurance” to build a robust Container Closure Integrity (CCI) Strategy from supplier to end-user
Animators : Charlotte MASY - GSK VACCINES & Carole LANGLOIS - SARTORIUS Moderator : Alain RACHON - MERCK
This workshop will discuss how BPSA recommendations can be implemented in real conditions (illustrated by case studies) to build an appropriate and comprehensive CCI strategy all along the Single-Use System life cycle. It will show that integrity assurance is a shared responsibility between supplier and end-user, which should be built on Quality by Design (QbD), Quality Risk Management (QRM), process validation and in-process controls. This approach, based on the understanding of the leak size and microbial ingress mechanisms, is supported by supplier integrity testing and end-user point-of-use leak testing. Attendees will have the opportunity to practice a risk analysis to identify the potential issues for SUS integrity and to set their own CCI strategy based on risk management. They will also learn about two main testing methods: pressure decay leak test and Helium integrity test. Open discussion around further developments (regulatory positioning, bacterial challenge studies, post-use testing) will also be organized.
Single Use Systems and supplier selection: how to define your user requirements, control your process from end to end, and secure your supply-chain ?
Single-use systems (SUS: single - use systems) are developing significantly in order to meet the needs of industry: ease and speed of implementation, indirect response to the cleaning validation issues, flexibility, CAPEX reduced... The use of such technologies leads to outsourcing and delegation to the provider of an important part of the process control that can impact, between other, product quality, supply chain and cost. It is therefore important to set up a strong partnership with the selected suppliers.
In this workshop, we propose to review the selection criteria for your future provider of SUS (writing of the User Requirements Specifications and the specifications). Once this exercise will be conducted, it is important to implement actions to secure the supply chain and control process in which in SUS are used. During various exchanges and exercises, we will define a common approach to answer to these questions. We will also briefly present the results of the Common Group of Interest on Single Use.
Protein drugs, which are the fastest growing sector of the biopharmaceutical industry, could contain traces of protein aggregates or exogenous particles which are clearly identified as one of the potential immunity-provoking factors.
Ensuring the safety and efficacy of Biopharmaceuticals requires a good understanding of any correlation between the amount and characteristics of aggregates and adverse immune response in patients.
To this aim Regulatory agencies are demanding more and more information (size, morphology, …) on the nature of particles within a pharmaceutical product. New guidance has recently been issued which provides a harmonized approach between US and EU requirements but some confusing interpretation remains.
During this WorkShop we will discuss the best practices in terms of analytical tools, quality control, particle characterization and setting acceptance criteria to comply with Agency’s requirements and expectations.
Cleaning validation including Concentration/Ultra Filtration membrane: a Quality by Design approach
Animators: Stéphane COUSIN - GSK & Walid EL AZAB - STERIS Moderator: Patrick MAHIEUX - ABLEUROPE
The workshop focuses on the cleaning validation and monitoring of the UF/DF membranes. During the workshop, we will discuss a risk-based method to define the Critical Quality Attributes (CQA) and Critical Cleaning Process (CCP) for the UF/DF cleaning validation and monitoring. Also, during the workshop the attendees will have the opportunity through an exercise to develop a risk-based assessment to determine the CPP and monitoring program to put in place to ensure robust and reproductible cleaning and lifetime of the UF/DF membranes. In addition, the objective is also to share the supplier side and an end-user side regarding UF/DF cleaning validation and strategy and program (cleaner choice, qualification of the UF/DF, extractible and leachable, cleaning validation, hold time, lifetime....) including the routine and on-going monitoring. Finally, you could advise/share on the lessons learned or failure that might happen during validation and routine use.
Quality by Design: the good, the bad and the ugly
Animators: Alain BERNARD - ABCONSULTING & Amer JABER - R-PHARM Moderator: Vincent GRIFFOUL - R-PHARM
QbD has been "launched" mainly by FDA several years ago. There are still a lot of misconceptions, fears, rejections or adoptions in different parts of the pharma industry.
This workshop will aim at "demystifying" the concepts, explain how QbD works and can be implemented in a smooth way in order to use a more scientific, risk-based, holistic and proactive
approach to pharmaceutical development. We will illustrate how a QbD based technical development promotes understanding of the product and manufacturing process and ensure that quality is built in, as opposed to being tested at the end. Ultimately we will demonstrate that an appropriate QbD approach, intimately integrated into e process development project, can create very significant value.
Reducing production operator errors and deviations through an effective training program strategy
Training is mandatory in the biopharma industry. However, the increasing level of complexity of the technologies used creates a very demanding environment
for the operators. Operation managers are re-thinking their training strategy. The objective is to move from the “read & sign” model to implement
operator training programs promoting effective acquisition of competences. Through experience sharing, the workshop will review the factors contributing to errors and deviations in production.
Ways of improving training effectiveness and knowledge retention will be explored.
This session will also be the occasion for attendees to get insights of educational methods enhancing training experience and facilitating knowledge retention.