19 - 21 February, 2019 | Novotel Hotel, AMSTERDAM, Netherlands

Conference Day 1

8:30 am - 9:00 am Registration and Coffee

8:55 am - 9:00 am PharmaIQ Welcome

9:00 am - 9:10 am Chairman's Opening Address

9:10 am - 9:45 am Identifying the Impact of Implementation: Commercial and Process Implications

Jean-Yves Bauer - Senior Engineer, MS&T / TLCM / IM-BIOPROCESS, GSK
- Analyse the impact of SUS implementation in driving forward GSK Vaccines product development
- Examine the commercial realities of implementation: what are the unexpected hurdles to overcome, and
what is the cost?
- Discuss what is next? What is missing from the current solutions and what do manufacturers need to see
from suppliers in their new technologies?

Jean-Yves Bauer

Senior Engineer, MS&T / TLCM / IM-BIOPROCESS

9:45 am - 10:20 am Defining Your Disposable Solutions Parameters – a Cell Therapy Case Study

Amy Shaw - Senior Scientist, Cell Therapy, Torque Therapeutics
- Asses the disposable technology currently available to decide whether it makes sense to move to a 100%
disposable facility or to use a hybrid system
- Create a spectrum of challenge and implement the most straightforward disposable components before
tackling the more complex
- Devise a cost benefit analysis to analyse at what point you should increase disposable uptake to move
towards 100%

Amy Shaw

Senior Scientist, Cell Therapy
Torque Therapeutics

10:20 am - 10:50 am The Customised Standard Protocol – An Approach to Extractable Evaluation for Single Use Systems

-Introduce in the standardised extractables protocol according to USP <665> and BPOG
-Highlight the advantages and limitations of standardised protocols
-Demonstrate the limits of standardized protocols
- Underline the requirement of customised standard extractables protocols

10:50 am - 11:20 am Coffee Break

11:20 am - 11:50 am Reverse Engineer Your Processes With The Final Requirements In Mind

Nadav Eshkol - Technology and Process Development Manager, Pluristem Therapeutics
- Discuss how to identify what your product’s post market commitments are likely to look like at the
beginning of the development cycle to ensure you design your manufacturing process to meet your
development requirements
- Minimise your ongoing production changes and maximise process reliability by commencing your
production and technology adoption with the end in mind
- Analyse the process impact on embedding scalability and flexibility at the beginning rather than end of
the design process
- Examine the cost benefit metrics around complete investment at the beginning rather than on a gradual

Nadav Eshkol

Technology and Process Development Manager
Pluristem Therapeutics

11:50 am - 12:20 pm Extractable Test Results From A Mono Layer, Fluoropolymer, Single Use Bag Generated Using The BPOG Extractable Protocol

Mike Johnson - Chair, ASME-BPE Polymer Materials Subcommittee, Life Sciences Business Development Engineering Manager, Entegris. Inc., Entergris
- Discuss the continuous concern with extractables and their impact on process fluids
- Hear about the data generated from using the BPOG protocol on monolayer fluoropolymer bag material,
void of any additives such as adhesives, plasticisers, lubricants or antioxidants
- Learn what the results mean for testing protocols and materials used in disposable technologies

Mike Johnson

Chair, ASME-BPE Polymer Materials Subcommittee, Life Sciences Business Development Engineering Manager, Entegris. Inc.

12:20 pm - 12:50 pm Moving Beyond Implementation – From Microbioreactors To Scale-Up In Microbial Process Development

Daniela Reinisch - Director, Upstream Development, Boehringer Ingelheim
- Discuss the best screening & process optimization solutions to scale your production
- Examine scalability case studies to see where you can apply industry learnings
- Discuss how scalability can be used to improve your process quality and reliability to avoid product and
capacity wastage

Daniela Reinisch

Director, Upstream Development
Boehringer Ingelheim

12:50 pm - 1:30 pm Technology Showcase Day

4 of our solution providers will share their latest technology innovations to help you optimise your
manufacturing processes. Take this opportunity to meet some the companies showcasing their solutions at
this event!

1:30 pm - 2:30 pm Networking Lunch

2:30 pm - 3:00 pm Maximise Your Downstream Capability Without Compromising on Your Product

Stewart Campbell - Gene Therapy Downstream Lead, Pfizer
- Discuss how to improve control of product quality for downstream purification
- Hear about the process requirements to move to 100% closed system processing to maximise your
conjugation and purification
- Discuss the realities of simultaneous clinical manufacturing and the best ways to ensure sterility in multi
purpose facilities

Stewart Campbell

Gene Therapy Downstream Lead

3:00 pm - 3:30 pm Continuous Downstream Processing: Comparability and Regulatory risks

Klaus Kaiser - Head of Downstream, Bayer
- Understand the basic approach to compare “traditional” batch manufacturing with continuous production
- Analyse the differences between tiered and phase dependent comparability approach
- Perform a risk assessment as basis to define the required measures for the comparability exercise
- Discuss applicability in clinical studies and manufacturing concept

Klaus Kaiser

Head of Downstream

3:30 pm - 4:00 pm Afternoon Coffee Break

4:00 pm - 4:40 pm Closed Systems Operation: A Risk Based Approach

David Estape - Technology Manager, CRB Group
- Define a risk based approach to assessing appropriate room classifications – and the process efficiency
gains this can generate
- Understand the different definitions to closed system processing – is your system closed systems or
aseptic and why does it matter?
- Validate and qualify system closures for manufacturing processes in accordance with lean manufacturing

David Estape

Technology Manager
CRB Group

4:40 pm - 5:50 pm Round Table Discussions

Use this opportunity to discuss with peers key challenges facing the industry and follow up on the day’s
presentations with a series of intimate round table discussions facilitated by our industry experts:
Each roundtable discussion will last for 20 minutes with the opportunity to rotate to a second discussion

5:50 pm - 6:00 pm Chairman's Closing Remarks

6:00 pm - 8:00 pm Networking Drink's Reception

After a full day of case studies and round tables, join our world famous drinks reception with your peers and meet our sponsors!