BioConnection B.V. / Oss, The Netherlands / April 9, 2020
BioConnection has sterile production capacity available for the battle against the Covid-19 pandemic
BioConnection (established in 2005) is an independent CMO (Contract Manufacturing Organization) in Oss, The Netherlands. We have an own facility and we are specialized in the manufacture of sterile drug products. Our GMP facility is EMA and US-FDA certified.
We have many years of experience in the development and sterile manufacture of drug products for both clinical trial and commercial (market) purposes. We fill in vials and syringes. We have a worldwide customer portfolio which includes among others the USA, EU markets and of course the Dutch market. As a result we have a great deal of expertise and market knowledge in the area of sterile productions.
Because of our network, experience and our own production facility, BioConnection is very well positioned to make a significant contribution in the battle against the Covid-19 pandemic.
Not only vaccines are required
Besides vaccines there is also a huge need for essential medications in IC units like muscle relaxants and sedatives. The current trend is that hospitals are making these medications in their own pharmacy. For the short term and on local hospital level it is a pragmatic way to cover urgent needs this is however not an ideal scenario for the long term. By shifting larger scale productions from hospital pharmacies to the CMO industry (example BioConnection) we can help a significant higher share of patients in a fast, efficient and cost effective way
In addition to the search for a vaccine against the coronavirus there is also a lot of focus and attention on developing treatments to alleviate symptoms of Covid-19. Most of these treatments are expected to emerge from existing compounds like viral inhibitors, etc. It is anticipated that Covid-19 treatments might be available in the short term whereas vaccines will take a longer time to reach the market because of the development time that is required to bring them from the lab bench to the market.
BioConnection can per immediate effect offer GMP sterile production capacity on their existing production lines (in vials and syringes) for essential medications like muscle relaxants and sedatives and also for clinical trial batches that are needed for coronavirus treatments.
Worldwide additional commercial scale production capacity is needed fast
Before the Covid-19 pandemic the worldwide production capacity for steriles was already very thin indeed. Once coronavirus treatments or eventually a vaccine will become available we might face a serious problem to produce the enormous quantities that are required in a timely manner. We have to therefore now orchestrate ourselves nationwide and worldwide to be ready for sufficient production capacity taking in to account that it requires several months to bring a GMP production to large scale commercial batch sizes. Shortages as we have seen in IC beds, respiratory equipment, essential medications and protective gear we must avoid for the production of vaccines and/ or treatments against the coronavirus by soon defining a good production and logistic strategy. A pragmatic approach could be to allocate the production over various facilities worldwide, to scale up existing facilities (e.g. more production shifts) or even to build additional capacity in existing facilities; various options and/ or combinations herein are possible.
BioConnection with their production and market expertise is ready to contribute in this discussion to define together with interesting parties a blueprint that eventually may help millions of people.
BioConnection can contribute in production: from research batches up to commercial scale productions for several millions of vials and syringes per year
- Per immediate effect BioConnection is able to offer capacity on their existing sterile GMP production lines (for vials and syringes) for research and/ or clinical trial batches. For the same purposes we can also offer our manual fill unit (class A, aseptic);
- We are expanding our production capacity with a second production line (standard up to 12 million vials/ year and on a campaign basis up to 30 million vials/ year). This new line (under construction since mid-2019) is anticipated to be ready for GMP productions as of early next year. As this new line is not yet in operation it offers for those parties who are interested the unique opportunity to dedicate a significant part of this capacity for Covid-19 production programs (treatments or vaccines). This new line is a unique advantage as many CMOs will most likely not be in a position to (quickly) free up significant production capacity on their production lines as they are all involved in ongoing production campaigns for their existing clients. This announcement is under the attention of multiple parties and it is therefore likely that our free capacity will sell out soon;
- BioConnection can increase for those parties who are interested the production capacity of their syringe filling line to several million syringes/ year.