BIO PRODUCTION FORUM MOVES R&D CLOSERTO INDUSTRIAL MANUFACTURING
The 7th Bio Production Forum which took place in Ulm this year, has once again succeeded in merging topics from the sectors of Product Development and Process Development to Production in one conference. Participants from ten European countries and the USA met for three days in June to exchange experience during the Conference. Further, various specialist exhibitors offered the opportunity to obtain information on the sectors of Production Technology, Analytics and Laboratory Services.
The declared aim of the Forum is to bring together the areas of early development and industrial manufacture even more closely. For this reason, this year's Forum also comprised an academic poster session for the first time. This poster session was supported by Boehringer Ingelheim and Cilag and attracted young scientists from Zurich, Vienna, Munich and Debrecen. The conference also reserved some time to provide the scientists with the chance to present their research in short lectures. The contributions - which were one of the Forum's highlights - ranged from lyophilisation of monoclonal antibodies and the influence of cyclodextrins on the stability of highly-concentrated antibody formulations to the examination of mechanical stress factors in disposable pumps used in biotechnology. The European Compliance Academy (ECA ) awarded a prize to the three best posters (chosen by a jury).
The Conference was opened with a lecture by Prof R. Werner, Corporate Senior Vice President, Boehringer Ingelheim. He showed the methods for and trends towards long-term viable biopharmaceutical production. He explained the product and market connections in a clear context and described the practical aspects of technology platforms and integrated concepts from process development to large-scale manufacturing in a holistic manner.
The following lectures on product and process development focussed on protein stability and immunogenicity of protein aggregations in various formulations and the influence of factors such as pressure. Furthermore, insight was also provided to the control and characterisation of biopharmaceutical products using analytical methods such as capillary electrophoresis and analytical ultracentrifugation.
Using concrete data the speakers showed how misinterpretations of known data or prior knowledge influence the formulation or characterisation of proteins and can lead to incorrect formulations or characterisations.
The topic of "Quality by Design" was examined by Victor Vinci, Eli Lilly, through a highly-topical "A Mab Study" (PQLI Initiatives) from the industry's point of view. A special focus was attributed to CMC development processes, risk-based process development and the use of multidimensional data models.
The following contribution by Michele Dougherty, FDA , provided the participants with an overview of the authority's perspective of Quality by Design.
Two lectures on disposables in development and manufacturing processes and on GMP and the regulatory aspects of development of biopharmaceuticals constituted the transition to the last section of the Bio Production Forum. Topics such as requirements on classical rooms and ventilation shafts were explained and comparisons made between modern barrier systems such as isolator and RABS. This section was concluded with a lecture on visual control of the manufactured products.
A further highlight was, of course, the guided tour of the biopharmaceutical production at Boehringer Ingelheim in Biberach which was supported professionally in an excellent manner. The tour was intensively attended by Dr Friedrich Haefele and his colleagues and provided Conference participants with an insight into the production of active ingredients and isolator production. Details on planning and implementation of room concepts, production processes and material flow were also presented.
Participants and speakers were very satisfied with the topics and the overall organisation of the Conference. For many of the international participants the visit to Ulm, until then unknown, and the tour to the Cathedral and through the historical Fischerviertel (Fisherman's Quarters) represented further highlights of their trip.
Author:
Matej Janovjak
... InSysteA GmbH, has more than 30 years experience in development, development strategies as well as in engineering and production of biopharmaceuticals. He worked for several years for Cilag AG in Schaffhausen. His last position was Director of Cross-Platform Process Management & Methods, GPSG EMEA. In 2010 he founded his own company with focus on the life cycle management of biopharmaceutical products.
