Biopharmaceutical Processes
Process Validation
Process Characterization Studies (Stage 1) Validation and Technology Transfer

Problem Statement

Regulatory expectations for statistically underpinned Process Validation (PV) has found its way into current guidelines such as the FDA’s life cycle approach to process validation from 2011 leading to demonstrating Established Conditions (ECs) in ICH Q12.
However, specific critical components to successful and accelerated biopharmaceutical tech transfer along the life cycle and processes validation (Stage 1-3) remain unresolved in industrial practice. This is due to the necessity of using scale down models, cost intensive set up of experiments and the complexity due to the interactivity of a multitude of unit operations. Most of the tasks, such as risk assessment, scale down model qualification, experimental criticality assessment, setting of control strategies, PPQ number estimation, and Continued Process Verification (CPV) require statistically based rationales to meet regulatory expectations in terms of risk-aware decision making.
Additionally, next generation bioproducts, such as biosimilars and Advanced Therapy Medicinal Products (ATMPs) accelerate the demand of clear workflows towards an efficient process validation. The commonly accepted hypothesis is that sound data science approaches will be a success factor in this endeavour.

To focus the work, the 2020 Data Science Assisted Biopharmaceutical Process Validation Workshop will focus on the first part of the above tasks: Process Characterization Studies (Stage 1) Validation and Technology Transfer. It will focus on the contemporary and novel approaches to meeting Stage 1 Validation and Technology Transfer expectations and ensuring consistent product quality. Methods and best practices embedded in workflows based on data science will be presented interactively, using case studies and hands-on workshops that enable reduced experimental effort towards a robust process. Thereby reduced out-of-specification rates, accelerated time to market and lower manufacturing trouble-shooting costs can be achieved.

Learning Objectives

• Understand regulatory perspectives on challenges and concerns in bioprocess validation
• Gain insight into new tools and workflows to target critical components towards a successful
    bioprocess stage 1 validation and technology transfer
• Gain hands on experience in solving challenges for bioprocess validation, such as scale down model
    qualification, experimental design & evaluation, as well as setting up a control strategy
• Understand challenges in process validation life cycle
• Explore challenges and emerging solutions in process validation for current and next generation
    bioproducts
• Participate in demonstrated application through review of multiple case studies

Who Should Attend?

• Process Engineers and Development scientists
• Manufacturing Science & Technology scientists
• Process Validation team members
• Statisticians supporting validation
• Operations managers, Laboratory managers

Course Setup

• Three half days starting 1st day noon and ending the afternoon on the 2nd day.
• Networking evening event
• Mixture of international reputed lecturers from industry
• Lectures and integrated exercises (bring your laptop)

Topics for the Biopharmaceutical Process Validation Workshop include:

[WPSM_AC id=12884]

Agenda Day 1 / Day 2:

[WPSM_AC id=12880]

When?

27 – 28 May 2020

Where?

Hochschule für Life Sciences FHNW (Nordwestschweiz)
02.S.21
Hofackerstraße 30
CH-4132 Muttenz
Schweiz
Map

Hotel Recommendation

Registration Fee

ISPE Members: 450 Euro
Non Members: 750 Euro

Students:
Registration Fee ISPE Members 45 Euro
Registration Fee Non Members 75 Euros
(limited offer, pls ask your ISPE Student Chapter for a Coupon Code)

To become a ISPE Member: Member Form.

Workshop Booking Form (Members, Non members and Students)

Contact: ISPE D/A/CH Secretary Rolf Sopp (rolf.sopp(at)ispe-dach.org)