UPSTREAMBIOPROCESS

DEVELOPMENTNew LIVE Online Course

COURSEOVERVIEW

Balancing the demands of product quality, processproductivity and scalability remain the key challenges forprofessionals involved in upstream process development.This course will address these core issues for bothmammalian and microbial products.

Starting with cell-line development, the course will moveon to focus on media selection, screening, initial upstreamprocess development and quality concerns to help you inlaying the foundations for a successful and productiveprocess. You will explore upstream equipment in-depthand start to consider process characterisation,performance validation and scale up. You will also discussthe needs of the downstream process, how collaborationbetween USP and DSP teams can be facilitated and howprocess transfer can be addressed.

Taught by Margit Holzer, an experienced bioprocessdevelopment expert, this course will deliver a wealth ofexamples and discussion to help you in your learning.

Margit is a specialist in process, product and analyticalmethods development for preclinical and clinicalproduction phases as well as for commercial supply.Aftercompleting her doctorate in Vienna, Margit beganworking at Boehringer Ingelheim, eventually establishingand becoming the head of the new division ofmanufacturing sciences. She moved on to become theQuality Director and later on the Technology, R&D andInnovation Director for NOVASEP in France, beforesetting up her own consultancy. She now assists clientsin the evaluation, optimization and development ofprocesses, analytics and technologies includinginnovative ones for Up & Downstream processing andFormulation. She has 25 years’ of experience in theindustry and has worked on more than 50 differentproducts.

MEET THE TRAINER

Dr. Margit Holzer

SESSION 1 AGENDA

Overview of BiopharmaceuticalsWhat are the key things we are trying to achieve – productivity, scalability and product qualityHow to choose the expression systemDiffering process development needs for animal and microbial cell types and viral systems

Welcome and Introduction Upstream Processing Objectives  This session will explore common upstream processing objectives and consider the following:

SESSION 2 AGENDA

Sequencing, Vector design and host cell requirementsCloning, clone screening and selection for different development phasesProductivity consideration of cell linesStability studiesChallenges of cell-line development for difficult to express moleculesCell banking and characterization requirementsVirus banking and characterization requirementsBenefit of platform cell lines and expression systemsParticular requirements for biosimilar products

Cell Line Development

This session will examine principles of vector design, cell line selection, clone selection and will giveguidance on cell and virus banking. You will learn:

Quiz

SESSION 3 AGENDA

Media screening and selection for different production stagesEvolution during process developmentTesting and characterization of mediaMedia preparation and stabilityViral safety & TSE concernsGMP considerationsPrinciples of supply chain management

Media selection

This session will guide you through important consideration for upstream media selection. Main topicsare:

Quiz

SESSION 4 AGENDA

Process flow diagram overview of different expression systemsScreening models and platformsProcess development phasesProcess optimizationProcess formats (e.g.: batch, fed-batch, perfusion) and impactsEvolutions during process developmentFocus on different process stages of different expression systemsControls and testing needed during initial process developmentHarvest considerations

Initial USP Development

This session will focus process design and development activities and will include talks on:

Quiz

SESSION 5 AGENDA

Integration USP & DSPHarvestingCell disruption & product recoveryProcess transfer considerations

Process integration and transfer

Consider the best practices for upstream and downstream processes integration and process transferinto GMP facilities including:

Exercise

Quality concerns

This last session will give you an overview of quality expectations and tools to be applied duringdevelopment. Main topics are:

SESSION 5 AGENDA - CONTINUED

Quality by DesignExperimental designKnowledge managementRisk management

Conclusions and Feedback

For information contact our training consultants

Jessica PurnellJessica.Purnell@informa.com

+44 (0)20 7551 9521

REGISTER ONLINE