”It is eye-poppingly clear that customization is an absolute asset in biopharma, from the first trials to the final fill”, says Heinz-Christian Rost, Market Unit Manager Life Sciences at Parker. “Our challenge as suppliers is to help customers design processes that are technologically perfect for their objectives, and that offer the highest level of protection for the product.” 

“Starting with a perfect process and ending in perfect protection” – that is the motto that Parker promotes when it comes to its customized approaches. Minimal risk and optimal product handling are key features, realized through single-use solutions. 

Open architecture 

The Covid pandemic has demonstrated how urgent the need for R&D, scale-up and mass production can get, as Rost points out. “Single-use can play a major role here”, he says. “From upstream processes to harvest, refinement, bulk storage and final fill. We provide, for instance, single-use systems with seamless tubing integration that mitigate the risk of leakage and contamination from component to tube to container.” 

Parker provides engineered solutions for this – not just at lab scale, but also with the increasing operational complexity at larger scales. The solutions address the issues of process development control, contamination risk, validation challenges and long development times. “We offer functional integration of multiple processing steps into one bioreactor-type unit”, Rost continues. “Imagine a scalable, fully customized, open architecture that enables things like continuous mixing, antifoam and draining features and aseptic ports and venting channels.” 

Driven by customer needs 

The prevention of leakage and contamination is also vital in downstream processing, transport and storage. Rost highlights some of Parker´s solutions in this area, including sampling systems using a patented ‘integrity seal’ and gentle fluid handling, all fully customized. “We like to keep our customers’ nervousness factor as low as possible”, he says with a smile. “We also offer advanced bulk management with laminar flow, for instance through an advanced distribution hub. Again, fully customized. After all, all customers have their own configuration of tubing and containers.” 

In short, Parker provides upstream, harvesting and downstream solutions that avoid manual connections and limit the stress that the product experiences. “And with the integration of pre-validated elements, you have minimal validation costs”, adds Rost. “Our customers are already making use of many of these systems, but the technology keeps evolving, using the latest advances and addressing emerging complexities. We expect that with the acceleration due to Covid, and the increasing demand for specialized approaches, we’ll see many more sophisticated innovations in the near future.”