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FOCUS DAY, 12 May 2014 (Monday)

08:15-08:30
08:30-12:00

NIBRT is a world-class institute that provides training and research solutions for the bioprocessing industry. Our mission is to support the bioprocessing industry by providing a unique learning experience for trainees in an environment that replicates the most modern industrial bioprocessing facility. In parallel, we also undertake leading edge research in key areas of bioprocessing in collaboration with industry. In 2012 NIBRT was awarded ISPE/Interphex Facility of the Year Award and Bioprocess International Manufacturing Collaboration of the Decade

 

FULLY BOOKED

 


12:00-13:00
13:00-13:10
13:10-13:50
keynote

Utilising new process development techniques and efficient processes to guarantee quality

  • Using solid economic procedures and processes - Innovative strategies to improve product quality
  • Identifying process efficiency analysis to drastically improve the quality of products
  • Implementing statistical analysis and DOE principles to ensure high level of quality in products
  • Using next generation manufacturing process development to establish a concrete methodology


Ronald C. Branning
VP, Quality
Gilead Sciences

13:50-14:30
workshop
process improvement

Case study:  Enabling richer scientific understanding and consistent product quality with high content online analytics

  • Developing innovative solutions to overcome long standing challenges
  • Accelerating the process development cycle
  • Streamlining scale-up and technology transfer activities
  • Using real-time analysis to increase production throughput while ensuring consistent quality and process control

 

Craig Dobbs
Senior Manager, Process Analytics
Waters

14:30-15:10
workshop
biotech technologies

Innovative Single Use Technologies and Trends in Biopharmaceutical Processes

 

 

  • The biopharmaceutical industry is becoming increasingly dependent on innovation. Single use technologies have changed bioprocesses by increasing productivity and quality, reducing costs and risks and adding flexibility.
  • During the talk we will show how single use technologies can improve even further by fully controlling the raw materials and manufacturing process. We will also discuss how single use technologies are offering great benefits in the reduction of contamination and continuous processing.

Juan Pablo Acosta-Martinez
Project Manager. Virus & Contaminant Clearance
Sartorius Stedim Biotech

Luke Coxon
Application Specialist – FMT
Sartorius Stedim Biotech

workshop
process improvement

Defense In Depth

Increasing redundancy in Biomanufacturing facilities

 

  • Strategy for increasing the robustness of manufacturing systems 
  • Introduces redundancy in manufacturing to mitigate the impact of failures
  • When used successfully, avoids disruptions while maximising likelihood of on-time batch release

 

Rick Johnston
Founder and Principal
Bio-G

15:10-15:50
15:50-16:30
workshop
process improvement

Quality Data Management and advanced control strategies for bio production allowing for real time product release and continuous manufacturing

 

Siemens

 

  • Achieving Real Time release and introducing Continuous Manufacturing

  • Continuous process verification and real time release strategies

  • PAT as an enabler for continuous manufacturing in Bio production for integrated upstream and downstream processes


Ivo Backx
Business and Project Development Manager Pharmaceuticals
Siemens AG

16:30-17:10
keynote

The first 7 levels of PAT

  • Development of reproducible fully automated processes
  • Plant characterisation and simple model based control
  • Enhanced target product and substrate at-line monitoring
  • Applications of spectroscopic analysis and MVDA for in-line monitoring of substrates and products
  • Process modelling and parameter identification with DoE
  • Upstream optimisation with a fully automated multi-bioreactor
  • QbD compliant process development-from risk analysis to the design and control space

Prof. Dr. Ing Reiner Luttmann
Head of Research of Bioprocess Engineering Analytical Techniques
Hamburg University of Applied Sciences

17:10-17:20

DAY 1, 13 May 2014 (Tuesday)

07:20-08:20
08:20-08:30
08:30-09:10
keynote

How Valeant Pharmaceuticals, a Virtual Company, utilises a unique model to manage over 800 CMOs

  • Risk based approach combining Factors and Criteria
    • Factors – Compliance, Supply Chain Continuity, and Financial
    • Criteria 1-5 (1 = Best CMO; 5 = Worse CMO and exit strategy)
    • SharePoint Cloud collaboration
    • Strong multi-way Quality Agreements

Robert Sparadoski
Senior Director GMP QA Compliance
Valeant

09:10-09:50
keynote

The Business Challenge ( Running through some background to the business reasons for taking this path)

  • The LAIV Manufacturing process and associated business constraints (an explanation as to why the process needed to change)
  • Using a systems thinking approach to project execution
  • Building individual capability and improving project delivery
  • Business results and tangible outcomes

Mark Proctor
Director Manufacturing Science and Technology
AstraZeneca

09:50-11:35
11:40-12:20
stream 1
upstream

The systems thinking  concept

  • Demonstration of organisational improvement through systems thinking.
  • Systems thinking in action
  • Simple concepts and tools to take away

Terts Ashibi
Associate Director – Programme Management
AstraZeneca

stream 2
manufacturing excellence and engineering

 Single-use (SU) bioreactors are being increasingly used in production processes based on animal (i.e. mammalian and insect) and human cells

  • Overview of single-use systems for the cultivation of animal and human cell cultures
  • Characterisation of single-use bioreactors by conventional and advanced engineering tools
  • Current and future applications of single-use bioreactors

Stephan Kaiser
Scientic Researcher
zhaw

stream 3
downstream

Development of sequential/parallel cultivation strategies

  • Integration of Expanded Bed Adsorption chromatography
  • Development of a fully automated industrial production plant
  • Optimisation of primary downstream operations and different purification procedures
  • Installation of advanced MVDA compatible data processing tools
  • Applications of Golden Batch on-line monitoring
  • Development of MVDA predictive process quality control

Prof. Dr. Ing Reiner Luttmann
Head of Research of Bioprocess Engineering Analytical Techniques
Hamburg University of Applied Sciences

12:20-12:25
12:25-13:05
workshop
upstream

New integrated approach to online process monitoring in Cell Culture applications

  • A new approach to online process monitoring and control for all Cell Culture applications
  • Viable biomass measurement with capacitance measurement technology
  • Optical DO measurement with digital data transfer
  • pH measurement with digital data transfer

 

Frank Wolpers
Sales Director Laboratory & Sensors
Hamilton Bonaduz AG

workshop
manufacturing excellence and engineering

Designing and building a flexible, single-use manufacturing operation for next generation mAbs

 

 

  • Selecting the correct technology platform to enable rapid scale-out in the future
  • The upsides and downsides of      choosing single-use
  • Choosing your collaborators
  • Future-proofing the facility and adding robustness of design by involving potential customers and regulatory authorities

 

Dr Koen Hellendoorn
Head of Sales Europe
Fujifilm Diosynth Biotechnologies

Nick Martin
Head of Operations
Fujifilm Diosynth Biotechnologies

workshop
downstream

Guidelines for the selection of chromatography media (resins) and steps to meet specific purification challenges

  • Case studies of different 2- and 3- chromatography step processes
  • Impact of media selection on process economy
  • Introduction of a new cation exchanger for MAb polishing displaying high binding capacity in combination with efficient removal of main impurities in MAb processes


Kristina Nilsson-Välimaa
Senior Research Engineer
GE Healthcare Life Sciences

13:05-14:05
14:05-14:45
stream 1
upstream

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 Horvat
Managing Principal Scientist
Genzyme

stream 2
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 Tengroth
Senior Manager
Pfizer

stream 3
downstream

  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 Alberti
QA Compliance Specialist
Novartis

14:45-14:50
14:50-15:30
workshop
upstream

New approaches in Upstream Risk Mitigation – Virus and Phage Removal by Nanofiltration with PlanovaTM Filters

 

 

  • Risk mitigation steps suitable to prevent virus contaminations
  • Virus and Phage Safety
  • Temperature sensitive media in bacteria fermentation
  • Case studies with Planova BioEX Virus Removal Filters

Stefan Schrankler
Senior Product and Marketing Manager
Asahi Kasei Bioprocess Europe

workshop
downstream

Maximising process value using modern chromatography media

Bio-Rad

  • 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 Voss
Application Specialist
Bio-Rad Laboratories

15:30-16:30
16:30-17:10
stream 1
upstream

Calculating total advantage of using fully integrated disposable manufacturing

  • Analysing medium and long term consequences of disposables on quality and costs
  • Evaluating operational cost and total advantages and weighing it up against long term costs vs. short term benefits
  • Understanding validation, QC and stability challenges


Gerald Kierans
Director, Technical Services
Pfizer

stream 2
manufacturing excellence and engineering

Understanding process variability in the different stages of a process lifetime

  • What is process consistency and how can we increase it?
  • What are types and different sources of variation?
  • Why is it important to identify, quantify and/or control the different variances feeding into the total variation?
  • Can we prioritise in variances?
  • Specific examples where process consistency was increased in a biomanufacturing process

Tom Vandebroek
Lead Purification Process Engineer
Genzyme

stream 3
downstream

A Quality by Design approach was used to optimise the PEGylation reaction of a di-PEGylated Fab therapeutic vaccine

  • The PEG-maleimide raw material used to conjugate two PEG chains per Fab is very expensive 
  • In order to minimise the cost of goods, the excess amount of PEG-Mal reagent added to form the diPEGylated product must be minimised 
  • Using a factor-prioritisation risk assessment tool, the many contributing factors of the PEGylation reaction were narrowed down to the critical few to be studied by DOE 
  • A scale-down model was used to screen the prioritised factors with a full-factorial screening design
  • The factors found to be significant were examined more closely via central composite response surface designs 

 

Richard Kensinger
Deputy Director Conjugation Chemistry / Unit Head
Sanofi Pasteur

17:10-17:15
17:15-17:55
stream 1
upstream

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 Fino
VP Manufacturing Operations
Protein Sciences Corporation

stream 2
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 Garcia
Europe Operational Excellence
Baxter

stream 3
downstream

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 Pere
Director, Product & Process Robustness
GlaxoSmithKline Biologicals

17:55-18:00
18:00-18:40
keynote

Exploring opportunities for biosimilar development and commercialisation vis-a-vis healthcare reform and rising costs

 

  • Overcoming technical, clinical, and manufacturing challenges of biosimilars
  • Understanding the implications of the healthcare reform on biosimilars
  • Harmonise understanding, ensuring safety and not over burdening biosimilar products
  • Exploring FDA's guidelines on biosimilars
  • Understanding regulatory and industry interaction – building a better regulatory setting for the biosimilar industry of tomorrow
  • Efficiently reducing costs and improving patient access

Michael Teasdale
Former Senior Director, Operational Excellence
Baxter

Mireli Fino
VP Manufacturing Operations
Protein Sciences Corporation

Robert Sparadoski
Senior Director GMP QA Compliance
Valeant

Ronald C. Branning
VP, Quality
Gilead Sciences

18:40-18:50
18:50-19:50

DAY 2, 14 May 2014 (Wednesday)

08:15-09:00
09:00-09:10
09:10-09:50
key note

Operational challenges in taking assays through development, tech transfer, commercialisation, and continuous improvement

 

  • Understanding, early on in product development, the effects of different matrices on assay performance. Impact on cell line and process development and formulation screening
  • Improvements in chromatographic or electrophoretic methods that show previously unknown peaks may lead to changes in specifications
  • Appropriate screening for chromatography columns to avoid batch-to-batch or even column-to-column variation
  • Appropriate Control samples and Control charts to support commercial operations
  • Successful assay tech transfer to different labs around the world
  • Future proofing: Will higher order structure methods be anything other than characterisation assays?

Vanessa Auquier
Principal Scientist, Analytical Sciences Biologicals
UCB

09:50-11:10
11:10-11:50
think tank
manufacturing excellence and engineering

Do you (company x) manage CMOs?

  • How do you manage them and how many do you manage?
  • What has been your best example of CMO Management?
  • What have been your biggest challenge managing CMOs or vendor management overall?
  • Do you have solid quality agreements in place with clearly defined roles and responsibilities?
  • Do all your CMOs align with quality agreement content…not format?
  • How do you rank CMOs?
  • How do you collaborate with CMOs as an extension of QMS and GMP functions?
  • What do you think some of the Risks are in managing many CMOs?
  • What’s in it for me at the end to go to a virtual model?

Robert Sparadoski
Senior Director GMP QA Compliance
Valeant

think tank
upstream

Utilising high-throughput clone screening to identify the optimum cloning

 

  • Integrating cell line and process development to reduce timelines and reach high productivity
  • Enabling high titre processes by incorporating DoE based approaches
  • Combing USP and DSP data - Connecting steps together to save time


Lada Ivana Laenen Horvat
Managing Principal Scientist
Genzyme

11:50-11:55
11:55-12:35
stream 1
upstream

Use of disposables for manufacturing is becoming a 'standard' in the biotech industry

  • There is a perception that the use of disposables will make biotech processes more economical, however, very often the effective interaction between involved departments during early clinical manufacturing is underestimated.
  • The author will give a detailed insight into effective manufacturing by using a flexible work model where many departments will contribute to the on-time availability of clinical material as well as the start of clinical trials. 

Wolfgang Noe
VP Technical Operations
Agensys

stream 2
manufacturing excellence and engineering

BIs has installed facilities for fully disposable processing in the US, Europe and China

  • Using the same technology platform facilitates process transfer amongst regions
  • A bright variety of processes, molecule formats and scales supports smooth transition from Phase I to commercial

Steffen Zeng
Director Supply and Technology Transfer
Boehringer Ingelheim

stream 3
downstream

Overcoming the challenges of bottlenecks in DSP by using lean and six sigma

  • Improving product yields, output and reducing cycle times
  • Significantly reducing batch cycle reduction and debottlenecking
  • Fully understanding the application of DSP and achieving better results with the product yield

James Sutter
BPS Down Stream Process
Merck

12:40-13:40
13:40-14:20
stream 1
upstream

A demonstration of industry and academia can engage to generate novel analytics

 

  • Improving process knowledge by comprehensive monitoring.
  • Use of rapid spectroscopic and chemometric analyses for inexpensive unit cost analysis.
  • Use a single platform analytical technology for both upstream and downstream applications.

Dr. Alan G. Ryder
Senior Lecturer
Nanoscale Biophotonics

stream 2
manufacturing excellence and engineering

Establishing technical lifecycle management from phase III clinical trials material manufacturing through to operational commercial manufacturing

  • What are the primary concerns when trying to deliver operational excellence into a development pathway?
  • Educating the industry to the benefits of operational excellence; to ensure process compliance, and to increase profitability of the product

Philippe Ronse
Director, Head Technical Life Cycle Management
GlaxoSmithKline Biologicals

stream 3
downstream

To ensure production of monoclonal antibodies according to current good manufacturing practices personals worked with a team to develop and introduce an improved process for risk management of leachables and extractables

 

  • Implementing a user-friendly, continuous and compliant process the existing procedures were revised based on customer feedback, sessions and a custom-made database was developed for storage of data and - moreover - easy accessibility of data for future reference and use.
  • This resulted in a lean method of management of L&E risk assessments and an improved control of materials used in production processes.

Edwin Mets
Senior Technician
Janssen

Sebastiaan Verduin
Scientist
Janssen

14:20-14:25
14:25-15:05
stream 1
upstream

  • Understanding the need and complexity of gene-therapy products
  • Platform development based on the insect-cell baculovirus system
  • The need to increase batch size to accelerate development

Arie van Oorschot
Head Process Development
uniQure

stream 2
manufacturing excellence and engineering

Having a clear vision on how a facility and a culture should change

  • Deploying the most effective tools and infrastructure and scaling fast
  • Leveraging current experience and developing an action plan to expand it further
  • Continuous communication feedback and observations to the shop floor to create a performance change management


Michael Teasdale
Former Senior Director, Operational Excellence
Baxter

stream 3
downstream

Octapharma has developed a new process for the production of a recombinant human FVIII product derived from a human cell line (HEK293F cells).

  • Clinical trials are ongoing with positive results. During process development several different approaches have been tested, old established techniques as well as new ones has been evaluated.
  •  Discussing scale-up of a new downstream purification process and also different affinity ligands that could be applied

Martin Linhult
Section Manager, Biopharmaceutical Production
Octopharma

15:05-15:10
15:10-15:50
keynote

Biopharma production capacity constraints

  • Case study 1: Global qualification improvement programme
  • Case study 2: Start-up of a vaccine fill finish facility
  • Case study 3: Site transformation project

Killian O'Driscoll
Director
NIBRT

15:50-15:55