Determine the most critical raw materials analysing the level of risk of potential contaminations
- Understanding how to determine the most critical raw materials in the process and the level of risk of potential contamination
- Identify and overcome contaminations coming from raw materials and the regulatory impact
Lada Ivana Laenen HorvatManaging Principal ScientistGenzyme
manufacturing excellence and engineering
Identifying the opportunities and overcoming the challenges in both internal and external tech transfer processes
- Having the right action at the right time whilst keeping up to date with the regulatory challenges
- Using risk based control strategies for complex tech transfer processes
- Adhering to both FDA and EMEA requirements and documentation
Charbel TengrothSenior ManagerPfizer
A multi-column process for semi-continuous chromatographic separations as alternative to batch chromatography
- Improved productivity (i.e. throughput per unit time and per unit volume of stationary phase) whilst fulfilling high purity specifications, when compared to related SMB processes
- Low solvent consumption due to internal recycle and mobile phase regeneration.
- Optimise operating parameters for cyclic steady-state using short-cut process design whilst respecting technical constraints
Andreas AlbertiQA Compliance SpecialistNovartis
Maximising process value using modern chromatography media
- The large scale production of biopharmaceuticals is continuing to evolve to meet the supply needs of the industry and ever increasing demands for value from national healthcare systems
- Bioproduction professionals are actively exploring and implementing several techniques such as Disposable Manufacturing, Process Analytical Technology and Quality By Design to address challenges.
- Concurrently, purification scientists are implementing new mixed-mode selectivity and high capacity chromatography techniques to maximize overall process efficiency
- In this talk we will highlight several examples where creative use of chromatography has produced tangible benefits such as higher process yield, reduced buffer consumption and processes with fewer unit operations; the talk will feature several cases spanning a range of proteins
Priv.-Doz. Dr. Carsten VossApplication SpecialistBio-Rad Laboratories
Reducing time, costs, risks while maximising level of production
- Achieving manufacturing processes for Flublok influenza vaccine
- Using warm base manufacturing facilities and integrating hybrid approaches by using single use facilities
- Using single-use systems in conjugation with multi-use systems to manufacture influenza vaccines rapidly
Mireli FinoVP Manufacturing OperationsProtein Sciences Corporation
manufacturing excellence and engineering
Increase of productivity through activity strategies implementation, performance and competences management
- Increase the moral of the teams through a reduction of stress situations and coaching process
- Improve compliance through a better visibility of deviations
- Increase customer satisfaction through a customer focus orientation
Luis Javier Martin GarciaEurope Operational Excellence Baxter
The Product Development Value Stream (PDVS) and Technical Life Cycle Value Stream (TLCVS) incorporate all aspects of the vaccine development process (from antigen construction to product launch, and throughout the licensed product’s life cycle)
- Product and Process Robustness (PPR) is considered as a critical activity within those value streams. PPR ensures that the manufacturing processes are built in such a way to be able to keep the process and product quality under control during production, during all phases of development.
- It also ensures that any change during the product’s life cycle is assessed in an appropriate manner, taking into consideration the potential impact on critical process parameters.
- During product development, a key objective of PPR is to establish the control strategy. This is achieved, first, by formulating the strategic intent, and then by defining product quality and process performance, and by identifying the CQAs and CPPs.
- During the product’s lifecycle, the control strategy, CQAs and CPPs are assessed and updated if required, based on the monitoring of process-quality indicators and product quality reviews.
- The presentation outlines how this PPR process is being designed and implemented in GSK Vaccines.
Marc PereDirector, Product & Process RobustnessGlaxoSmithKline Biologicals