Annual Report for 2017 from the BFS IOA Chairman
Dear BFS friends,
Finally, the spring has come to Europe, and it is time to look forward to our Annual General Meeting in the BFS IOA, that traditionally will be hold in conjunction with the European meeting for our association.
Before we take a closer look at the upcoming AGM for 2018, I would like to give you a short summary of our achievements in 2017. Last year was really an exciting year for the BFS IOA, and we could finalize some of the activities we have been involved in during several years.
Milestones in 2017
As you probably have heard at our meetings in 2017, we have for a long time been cooperating with the PDA (Parenteral Drug Association) in order to issue a Technical Monograph for Blow-Fill-Seal production. A ‘Memorandum of Understanding’ between the PDA and the BFS IOA was signed already in 2012, and it was then agreed that the foundation for the new TR should be the ‘Point to Consider’ document written by the BFS IOA.
Throughout several face-to-face meetings, telephone meetings and electronic reviews, the text have been revised and extended to cover the latest experience of BFS Operation. The result was the new PDA TR 77, The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology, that could finally be issued in February 2017. This mono¬graph is now the first official document offering guidance for how to produce sterile products by BFS technique. Please let me express my sincere thanks to the team who made this long time requested publication become a reality!
In addition to the document above, we have also been approached by the German publishing company ECV, Editio Cantor Verlag, to let them print and sell a booklet of our original ‘Points to Consider’ document from 2012. The PTC document has earlier only been available to members in the BFS IOA, but we decided that this agreement would offer knowledge about the use of BFS technology to be spread in wider circles, for example companies looking for understanding if BFS could be an option for them, or for students in universities who want to learn more.
This booklet can be purchased either from ECV, or directly from the BFS IOA for only € 20 or US$ 25.
In parallel, the Board of the BFS IOA is working with an updated version of the original PTC document, and we hope to be able to offer this new version to our members only during end 2018 or beginning 2019.
Another major achievement in 2017 was that we signed an agreement with the Monash University in Melbourne to sponsor their scientific work around Computational Fluid Dynamics. The team at the Monash University, led by Dr. Meng Wai Woo, have a huge experience in CFD. For many years, they have had a cooperation together with the Glaxo Smith Kline site in Boronia, Melbourne related to BFS studies in several fields. With the sponsorship from the BFS IOA, their findings around how particles move in the BFS environment, a lot of valuable understanding in this topic will be available to the BFS IOA community. There is a strong need to better understand and control particulate movement to ensure aseptic conditions within the process. The project will also showcase the application of a predictive platform for particulate control.
The sponsorship from BFS IOA for the first year will be AUD$ 30.000, and our intention is to continue the support also for a second year. This will be included in our budget for 2018/2019. We look forward to getting a presentation about the proceedings from the Monash team later in 2018. In the meantime, I can recommend you read the presentation that Dr. Woo gave at our meeting in Melbourne in November 2017.
Another major milestone for 2017 was that BFS IOA got an invitation from CFDA to come to China to give a training seminar around the BFS technology. This 1-day BFS Technique Forum then took place in the city of Kunming in March 2018, and was attend-ed by nearly 90 CFDA officials as well as some current and potential BFS operators. The feedback we received afterwards was that this seminar was very well appreciated, and it’s not unlikely that it will be followed by one or more seminars in the future. There is a huge interest for BFS technology in China, and it is really a fast-growing market.
I believe you all are aware of that a concept paper for the new version of the EMA GMP Annex 1, ” Manufacture of sterile medicinal products” was sent out for public consultation in December 2017. Since there are some additional demands for BFS technology, the board gathered for a one-day meeting in order to send in comments from the BFS IOA. We are with great interest looking forward to seeing how the final version of the new Annex 1 will be written, since this might have some impact on how we operate our machines. As soon as we get feedback, we will inform you.
In general, our association have had another successful year. The number of members increased to 74, and still more than 50% of those come from Europe. However, we see an increasing interest especially from Asia, and with the new promotional leaflet that was launched during the year, we hope to attract even more members for the coming year.
Meetings in 2017
Also during 2017, we have as normal arranged three meetings, one in each region Europe, America and Asia/Pacific.
The European meeting, that also was our Annual General meeting for 2017, was held in Elverum, situated in the beautiful landscape of Norway in June 19-21. The meeting attracted 97 attendants, which is a higher than normal number for a European meeting.
We were kindly invited to visit the Curida plant there, and it was inspiring to feel the spirit and enthusiasm from the employees. After being part of a big pharma company, who intended to close the site, the factory was taken over by the management. This opened opportunities for the site to bring in new business.
At the end of meeting day 1, we went out on the biggest lake in Norway, Mjøsa, for a two -hour lovely trip with the old steamship “Skibladner”. The sceneries with all the mountains around the lake was breath-taking, and we afterward had to “recover” by a dinner, perfectly arranged by Curida, at a local restaurant and snaps-distillery, Atlungstad Brenneri near by the lake.
In September 27-29, we travelled to San Diego, CA, for our US meeting. Although San Diego is a very nice town with lovely climate, the absence of a site visit unfortunately made the number of participants to be 57, which was somewhat lower than the rather high number we have been used to during the last years US meetings. Anyway, we had several interesting presentations and valuable discussions at the meeting, and we also managed to keep the tradition with a BFS IOA boat trip in the San Diego harbour.
For the last meeting in 2017, our Asia-Pacific meeting, we returned to Australia. Since our earlier visit there in 2013 was very successful, and the BFS operators there are very proactive and open to show their facilities, we decided to go to Australia again. This time the meeting took place in Melbourne, and included a very well-organised site visit to the Glaxo Smith Kline site in Boronia, just outside Melbourne. The GSK plant in Australia is the only BFS manufacturing site in the company, and has therefore an important role regarding supply of liquid respiratory products from GSK. In addition, the site is also working with development of new BFS products for the future.
As I mentioned above, GSK has for many years worked together with the Monash University for scientific studies related to BFS. Due to this cooperation, Philip Leslie at GSK proposed to the BFS IOA to initiate a relation and a sponsorship with the Monash research team. This then led to the agreement for the CFD study that I’m convinced will bring lot of valuable knowledge to us.
Although Melbourne is situated close to the Pacific Ocean, we for once didn’t have any boat trip in our programme. Instead, the BFS IOA Dinner was enjoyed at one of the many famous wineries outside Melbourne.
With some variation from one meeting to the others, we have tried to stay to some topics that have been included in all three meetings. Some examples are; ‘Impact of the new USP <661>’, ‘Particle Inspection’, ‘Bulk handling of Resin’, ‘A new safe method to perform Extruder Challenge Studies’, ‘Open discussions around Media Fill’ and of course around the new PDA TR 77 for BFS. I am very happy for the open and good discussions we had during the two latter, because this is when the association really works from its best side; sharing experiences and trying to find a common base level for the future.
I also want to take the opportunity to express my sincere gratefulness to the sites for inviting the BFS community to come to visit their facilities. And of course, I also want to say thank you for the all the nice treatment we have received regarding food and refreshments before and after the visits. During these site visits, we have appreciated the openness we have met, but we also felt the great pride of the companies who have got the possibility to show their philosophy around BFS production. I hope this will inspire other companies to show their production facilities in the future. We have a lot of common interests in the rather small BFS world that we can share and support each other with.
Some words about the AGM in 2017
Our Officer of Operation, Mr. Jesper Laursen, presented the accounts for 2016 as well as the budget for 2017. They were both approved by the members. There were also voting for two positions of the Board, Chairman and Regulatory Officer. For these positions, the present holders were re-elected for a new term of two years.
This gives me the opportunity to present the Board for BFS IOA for 2017/2018 for you;
Peter Åkerman, Senior Adviser, AstraZeneca, Sweden, (re-election)
• Technical Officer:
Kevin Downey, Head of Quality, TEVA Runcorn, UK,
• Regulatory Officer:
Dr. Martin Haerer, Senior Director R&D/Qualified Person Rommelag CMO,
• Officer of Operation:
Jesper Laursen, Business Director, MELITEK, Denmark,
• Appointed Board Member for US:
Bill Hartzel, Vice President, Business Development, Respiratory & Ophthalmic
Catalent Pharma Solutions, NJ, USA
Let us now take a look at what we have in front of us!
In a few days we welcome all our members to our AGM and European meeting in 2018. The meeting will this time take place in Colmar, a picturesque town in the lovely French Alsace region on May 14-16. Thanks to the kind hospitality of Recipharm, we have been invited to visit their manufacturing site located in Kaysersberg, nearby Colmar. The site has recently been extended with some brand new high-speed BFS machines. Thus, we will be able to see a state-of-the-art installation, which I am sure will be of great interest for us all.
The agenda for the meeting is now available on our web-page, and I hope the mixture of different topics will offer everyone to find several interesting presentations. I can also inform you that it seems like we will have a new ‘all-time-high’ when it comes to the number of attendees. A few days ago, we were already far above 120, so if you have not signed up yet for the meeting - please hurry up !
We will finalize the second day by our Annual General Meeting business. Among other items, you will there get the chance to review and approve the Accounts for 2017, and also vote on the proposal for Budget for 2018. There are two of the positions in the Board up for election; Technical Officer and Officer of Operations. From the Board, Kevin Downey and Jesper Laursen respectively, are nominated, but of course we welcome other suggestions for candidates. If you have a recommendation for a candidate, please let me know, so we can add that name to the voting process.
Regarding the two remaining meetings in 2018, we have decided to swap the order. Normally we arrange the US meeting before the Asia meeting, but due to the choice of locations in 2018, we concluded that it will be better the other way around. Therefore, the Asia Pacific meeting, that this year will take place in the exciting country of Uzbekistan, will take place in Tashkent on September 25-27. This is the first time our association will arrange a meeting in this region, and we hope that it will attract many present and new members from the surrounding countries. Of course, we are also happy to offer you a site visit, since we have been invited by Dentafill to visit their factory.
Then for our US meeting, we will now finally have the opportunity go to Miami/Fort Lauderdale where we have been invited to visit the impressive new built facility of Unipharma. This is a long-awaited site visit, that we have been talking about for many years, and we are now very happy to realise this. Taking into consideration that September most often is the hurricane season in Florida, I am sure you understand why the US meeting is postponed to December, where the meeting will take place on the 5-6th.
Some final words
As every year, I once again want to encourage you all as members to come up with suggestions of topics that you want us to put more attention to in our programs. And, even better, if you have something you want to present from your own experience that will be even more appreciated! You are always welcome to contact us in the Board to discuss any ideas that can contribute to return a better value for the BFS community.
Finally, I want to thank you all for your interest in the Association during 2017, and I hope you will continue to support the Association with your membership also in 2018.
On behalf of the whole BFS Association I want to take the opportunity to express our sincere gratitude to all our valuable Sponsors for their important contribution to our mission.
Most welcome to the meeting in Colmar, and looking forward to see you there !
Best personal regards
Chairman of the board BFS IOA