PHARMA CONGRESS: INNOVATIONS IN PRODUCTION AND PROCESS TECHNOLOGY
The Pharma Congress Production & Technology has been established as meeting point for the pharmaceutical industry for years now. The core of this event in its 19th edition are again case studies of current projects as well as networking with colleagues at the exhibition PharmaTechnica with almost 90 exhibitors.
Congress delegates have again lots of possibilities on 28 and 29 March: they can choose from six international conferences (please see box) with more than 30 speakers coming from the pharmaceutical industry, from authorities and universities. The lectures' close connection and general meaning to the pharmaceutical practice has always had priority. Case studies are best suited for a benchmarking with own projects. Furthermore, they show the actual state-ofthe- art with regard to pharmaceutical production and technologies. Live Demos create another direct link to process technology. This year the Live Demos as part of some of the conferences will concentrate on practical demonstrations concerning the topics single use applications, sterile filling technologies as wells as aseptic technologies.
The two keynotes are another, also firmly established part of the Pharma Congress. They open the two days for all congress delegates. This time, we will be looking into the future and make some predictions in terms of technological developments for the production of solid as well as of sterile drugs. On day one, Daniel O. Blackwood from Pfizer in the US, will take a look at how technology progresses for the production of small molecules. On day two, Jörg Zimmermann, Vice President of Vetter Pharma Manufacturing, will talk about trends in sterilization and will focus on the developments and expectations of the markets.
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As in the last year, two subjects will continue to keep the pharmaceutical industry busy this year; The revision of the EU GMP Guideline Annex 1 for the production of sterile drugs and the integrity of data.
Although it had already been planned for 2016 the publication of the first draft on the public comments to Annex 1 won't be published before the second quarter 2017. So far the new structure of Annex 1 was presented in the first publications. It will be oriented more towards the main chapters in Part 1 of the EU Guidelines to Good Manufacturing Practice. It is unlikely that the new structures will contain completely new topics and contents. It is rather very likely that the revised Annex 1 will take up the contents of the actual document and develop them further. New regulatory developments - such as the expectations of a risk based approach as well as the regulatory considerations on new technological developments (RABS, Blow-Fill- Seal, Single Use Systems) - will surely be integrated into the document. The event "Regulatory Trends: Revision of EU Annex 1" will take up the current state and formulate the industry's expectations with respect to the authorities.
The integration of new technologies in the aseptic / sterile production which can be found in Annex 1 is traditionally one of the Pharma Congress' priorities. Actual case studies from industry will be summarised in the subject area "Aseptic Processing" and will be complemented by Live Demos from the exhibitors.
Apart from the new technological developments one of the huge topics of the last years will also find its way to the Pharma Congress: data integrity. International regulatory authorities focus more and more on this topic when they are carrying out their inspections. Many FDA warning letters and European non-compliance reports document explicitly that a lot of companies haven't yet clarified or implemented some of the points - although data integrity is one of the main principles of Good Manufacturing Practice. The event "Manufacturing Data Integrity" will put the focus on aspects of data integrity seen from the point of view of users and inspectors.
Continuous manufacturing also has become one of the trends in manufacturing technologies. Some companies already see the transition from batch to continuous manufacturing as the biggest paradigm change in the pharma industry since the introduction of validation.
The case studies presented in the conference "Continuous Manufacturing" show that more and more companies are active in this area - as examples from TEVA, Janssen, UCB Pharma and Hovione demonstrate. But the agenda also comprises a key lecture on the risk based approach to implement continuous manufacturing.
Apart from the continuous manufacturing there will be other procedures and technologies that will play a role in the next years. The change from block busters to the so-called niche busters also poses new challengers to the companies and to their flexibility. The programme of the conference "Technology Trends" includes two more highly interesting technologies, namely the use of 3D printing in pharmacy and needlefree injections. The requirements for the prevention of cross contamination are still of great interest and will also be addressed. Gedeon Richter and UCB Pharma will report how the toxicological evaluation of limit values can be dealt with on the one hand. On the other hand, they will cover how a risk analysis tool can be used to determine the required containment level.
Authors:
Dr Robert Eicher
... is Operations Director and organises and conducts courses and conferences on behalf of the ECA Academy around pharma technology.
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As Operations Director
Dr Andreas Mangel
... organises and conducts courses and conferences for the ECA Academy in the areas sterile production and computer validation.
