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.
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.
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.
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:
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!
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.
The participants will be able understand and learn:
ATMPs from research to production phase; how data integrity / data traceability can make the difference throughout the product life cycle.
The participants will be able to understand and learn: