Biopharmaceuticals has become a main pillar in the pharmaceutical industry, with significant transformation in the development, strategy, technology and operations. This transformation is a continuous process, which is impacted by other developments in digitalisation amongst other factors.
Entirely new concepts, such as gene - and cell therapy, are being brought to market, which offer even more possibilities to regenerative medicine or disease remission. However, there are still operational and technological challenges.
Reproducing large molecules reliably at an industrial scale requires manufacturing capabilities of a previously unknown complexity and sophistication. The starting material that produce recombinant therapeutics are genetically modified living cells that must be frozen for storage, thawed without damage, and made to grow in a reaction vessel. The molecules must then be separated from the cells that cultivated them and the media in which they were produced, all without destroying their complex, fragile structures. This process requires new technologies and capabilities and will be explored at our conference.
Similarly, in GMP and Quality there are challenges, for instance working with a non-sterile starting material in a sterile and aseptic manufacturing process, where it is needed to prove that the micro-organisms are from starting material only and not from processing. Challenges that need new and innovative approaches.
The 2019 ISPE Europe Biotechnology Conference will address these topics with industry case studies and plant tours. Most important, the conference will allow for collaborative dialogue with presenters, regulators, industry, peer groups and top managers in an interactive forum.
Technologising Advanced, Therapy Medicinal Products (ATMPs)
ATMPs, such as Cell - and Gene therapy, will become the products of the future, addressing personal medicines tailored to the patient needs. The field of ATMPs is large. However, compared to other biopharmaceutical processes, such as cell culture processes, the production technologies as well as the interpretation of regulatory guidance’s are significant hurdles to speed up ATMPs to enter the market.
To address the technologies and regulatory cornerstones of these products, ISPE is introducing a workshop at the 2019 ISPE Europe Biotechnology Conference. The workshop will be offered as a special activity running parallel to the Plant Tours.
The objective of this workshop is to elaborate together on the following aspects to modify with technology ATMP production:
The workshop will also present regulations around these products. The following topics will be presented and discussed:
The purpose of the workshop is to work within small groups to share thoughts and knowledge around the products of the future. Several subject matter experts will mentor and monitor the workshop sessions in order to generate and drive operational content.
Specific technical topics and regulatory requirements will be illustrated beforehand in order to align all participants to achieve the workshop goal – operational content. The content will be defined in sub-groups according to the participants expertise.
Participants willing to deliberate around these topics are welcome to participate.
Join us and register online today!
Professionals at all levels of the industry from young professionals to the most senior executives, Communities of Practice, special interest groups, pharmaceutical industry equipment and services suppliers, and regulatory professionals.
Young Professionals Senior Executives Communities of Practice Special Interest Groups Equipment and Services Suppliers Regulatory Professionals