Featured Sessions

Take advantage of two unique opportunities to engage at the 2020 ISPE Biotechnology Conference - plant tours and workshop sessions.  Both opportunities are included with your event registration.


Plant Tours 

Catalent

8 October 2020

1330 – 1430

Catalent


Catalent Brussels belongs to the Biologics division of Catalent Pharma Solutions, #1 industry partner in drug development and drug delivery technology with 80+ years of experience to help patients live better and healthier lives. Our 600 colleagues are specialized in the fill and finished manufacturing and delivery of drug products on a wide span of markets, with approval received from FDA, EU, Japan, Brazil in particular. We produce annually 60 million of prefilled syringes for a large variety of customers, ranging from the top big pharma and biotech firms to emerging innovators.

During the visit, you will have the opportunity to discover our four different filling lines, as well as our automated visual inspection lines and one automated autoinjectors assembly line in our packaging area designed for biotech products. We will also showcase the innovative technologies used within our laboratory to ensure reliable treatments. You will learn how our community of 1,500+ scientists overcome the most difficult challenges related to the development of life-saving treatments.

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Produlab, the Netherlands

8 October 2020

1330 – 1430
Placeholder Person Graphic
Kris Scheyltjens
Manufacturing Project Manager
Produlab
Guide

Produlab Pharma (PP) is a Dutch, privately owned Contract Manufacturing Organisation that operates a new facility at their premises in Raamsdonksveer, The Netherlands, for the production of animal health care products. In the new facility sterile and non-sterile liquids are produced. The production process includes a lot of operator handling.

Together with Bilfinger Tebodin Netherlands B.V., Produlab created a virtual environment op the clean rooms in the facility. Production manager Kris Scheyltjens of Produlab will guide you through the various clean rooms while explaining the processes performed in the facility. After the tour there is time available to ask questions and to view specific areas of interest in the clean rooms.

In the facility production has been started since September 2020 with a production line for 2000 litre of liquid product and filled into several vial formats. During the next year the production will be extended with several production lines in mobile vessels and a Vacuum Processing Unit to allow for a wider variety of products.

The production process includes a lot of operator handling. The operator is guided through the process by the automation system, while all activities and process data is logged. An integrated solution with other business system is created to ensure proper and paperless operation, while tracking of equipment and materials is performed.

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Takeda Lessines

8 October 2020

1330 – 1430
  • Takeda img 1
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Takeda Lessines was originally a specific department of Travenol/Baxter, the site built in 1970 has continued to evolve year-after-year and currently has more than 1100 FTE, 24/7 operations and spans nearly 19 000 m².

Takeda Lessines specialises in producing treatment for people with primary immunodeficiency disorders associated with defects in humoral immunity.

Gammagard Liquid, one of our signature products, is also indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

Lessines is one of the company’s factories and includes:

  • Three IG purification lines for Plasma derivatives, each with its own specialisations (capacity of 38 T.)
  • Two aseptic filling lines including one in RABS (capacity of 44 T.)
  • Two packaging lines including the packaging centre of excellence for immunology and haematology with a capacity of 11M vials with geographic coverage of more than 80 countries around the world.

As part of this virtual tour, you will have the opportunity to visit one of our three production departments, namely Purification.

We hope to see many of you there!

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Workshops

GMPs for ATMPs are changing, since May 2018 the European Commission has implemented a specific guideline for ATMPs. As part of the 2020 ISPE Biotechnology Conference, we offer two virtual workshops to discuss, debate and identify potential deliverables. The two workshops will be organised in separate virtual rooms and the results/summaries will be shared at the end of the two sessions.

Workshop 1: GMPs for ATMPs Implementation

8 October 2020

1400 – 1700

Speakers:

Jean-Francois Duliere
Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
Chair
Placeholder Person Graphic
Chiara Negrini
Project Engineer
WOOD
Co-chair
Placeholder Person Graphic
Lucrezia Negri
Pharma Process Engineer
Wood Group

Focus:

The participants will be able understand and learn:

  • How to build a Contamination Control Strategy to prevent product contamination during the process. Using Risk Assessment tools to provide information to understand where and how to install environmental monitoring and how to develop a microbial control strategy
  • Ways to design a facility to manufacture ATMPs with manual aseptic processes and avoid product contamination during production
  • How to comply with regulations and deliver the products without risks for the patient. Looking at what kind of testing can be done
  • Where are the critical points of the facility to improve the design?

Organisation:

  • Short presentations to describe the content of a subject.
  • Work in small groups to discuss and find ways to reach the objectives of delivering products safely for the patient. As ATMPs industrial production in new ground, there open terrain to find adequate solutions.
  • The most important part of these exercises is how to work together

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Workshop 2: Digitalisation and Big Data Analytics in the Product Life Cycle of Advanced Therapies

8 October 2020

1400 – 1700

Speakers:

Christoph Herwig, PhD
Professor
Vienna University of Technology
Chair
Placeholder Person Graphic
Alessia Gasperoni
Pharma Process Engineer
Wood Group
Co-chair

Focus:

ATMPs from research to production phase; how data integrity / data traceability can make the difference throughout the product life cycle.

Deliverables:

The participants will be able to understand and learn:

  • How each product life cycle stage works and what it needs
  • The Chain of data through the product life cycle for ATMP’s
  • How Data, Processes and systems are interconnected
  • The importance of holistic control setting throughout the cycle

Topics that will be discussed:

  • Topic #1: Input and out puts for the current phase of the product life cycle
    • List what works, results, data you expect from the preceding phase of the product life cycle
    • Mention what in your experience is missing and propose what you would like to get form the preceding phase
    • Describe outputs from your current phase and how you would have the transferred to the next phase
  • Topic #2: Data Type / Data Needs for ATMP processes
    • What type of data do you generate on your process in which step of the product life cycle?
    • Transfer strategies of data sources
    • How do you handle the complexity?
    • Data repository (database / data lake)?
    • Bespoke solution developed in-house Vs Commercial solution?
    • Data contextualization
    • Data Visualization
  • Topic #3: Applications of Data Analytics
    • Where do you see Data Analytics providing most support?
      • E.g. Process Design, Process Optimization, Process Monitoring etc
    • What is the major pain points?
    • What is the single most impactful example of Data Analytics applications you can share?
  • Topic #4: Data Analytics to support the process and production Control Strategy
    • Where do you see Data Analytics supporting your Control Strategy?
      • E.g. Process design; real-time monitoring; Advanced Process Control
    • What are the perceived challenges?
      • E.g. Technical; Skills; Regulatory

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