The BioTech 2019 will take place from July 2nd to 4th at the ZHAW School of Life Sciences and Facility Management in Wädenswil, Switzerland. The Biotech 2019 will deal will potentials and challenges of single use technologies in the biopharma industry.
The conference program covers scientific lectures, talks and company workshops. Additionally, all attendees have the chance to discuss questions concerning the implementation of single use technologies with manufacturers, users, regulatory experts and representatives of various organizations.
Single use technologies have become a biopharma industry standard. The majority of established developments has been implemented in the upstream process; now the challenge is to find solutions for the process intensification.
Furthermore, studies show that a continuous downstream process not only improves process reliability and the monitoring of product quality but also the average plant utilization; it is just a logical conclusion that there is an increased interest and demand in single use technologies for a continuous downstream process.
However, challenges persist. One such challenge is the contamination of leachables and extractables in the fill & finish phase, which is particularly problematic given the proximity to the patient.
In order to tackle this challenge we have developed a completely new and almost 100% reliable logistics process for liquid drug substances in single use bags.
This is how we close the gap between the Down.Stream and the fill & finish process in the biopharma industry.
We will discuss our scalable and standalone freeze-thaw platforms that can be used with any established single use bag and that are part of the logistics process developed by us on July 3rd at the BioTech 2019. You can find us in hall RA O2.31 from 11.30 AM to 1.00 PM and from 3.00 to 4.30 PM.
Like all our systems, our plate-based freeze and thaw systems are compatible with single use bags of any size and from all established manufacturers. We have developed freeze & thaw facilities for stability studies as well as small and large batch sizes. This allows you to manage all phases – from the lab to large-quantity blockbuster production – with one single technology. Like this, our freeze-thaw units offer maximum scalability.
With our technology, the freezing and thawing process takes less time. Patient safety and efficiency are pushed to the next level. The constant freezing and thawing allows for the best possible preservation of the liquid’s consistency.
• compatible with single use bags from any established manufacturer
• maximum scalability (from the lab to blockbuster level)
• one system for all clinical phases
• quick and consistent freezing
• high degree of patient safety
RoSS.pFTU lab scale is our smallest freezing unit and it is designed for preclinical studies, small batches of liquid substances as well as CGT and BDS tests. The RoSS.pFTU lab scale freeze-thaw platform is now available for rent. You can test the unit for up to three months and the rent will be deducted from the purchase price in case you decide to keep the platform. Otherwise you can simply return it at the end of the trial phase.
RoSS.pFTU small scale is our freeze-thaw solution for small batches and studies.
RoSS.pFTU large scale is our “standard” freeze-thaw platform. This freeze-thaw platform is the ideal scalable solution for medium-size and large batches.
RoSS.pFTU blockbuster scale is our biggest freeze and thaw unit for “bulk drug substance” of up to 300 l per unit. This freeze-thaw platform for very large batch sizes is set to replace the Cryovessel as a single use solution in the near future.