The future of single use solutions in bio-manufacturing

Last week, we headed to Amsterdam to attend the Disposable Solutions in Bio-Manufacturing conference. Over a fascinating two days, leading experts shared case studies, insights into the problems they had faced and their vision for the future of the industry. Below are some of our key takeaways from the event.

The Future of Single Use

How the industry is set to develop, in the next year and beyond, was a key talking point during the conference. Todd Andrews of CPC kicked off the event by discussing the four trends he saw to be most significant for the future of disposables; standardization, assurance of supply, sustainability and cell & gene therapy.

Naturally, these themes ran throughout the conference. At different points, the work of BPOG and BPSA to move the industry towards standardization was recognized, with many supporting initiatives to create cohesive systems.

Assurance of supply was also discussed at length. Communication and flexibility was seen to be key factors, as well as comprehensive forward planning. Oonagh McGarry, Senior Process Equipment Engineer Consultant at Pfizer, aptly pointed out that when securing your own supply it is crucial to look at supplier pinch points and factor in when their supply may be at risk.

During the roundtables on the second day, all attendees worked together to discuss what they wanted to see in the industry over the next 12 months. Answers included; an industry platform to discuss, collaborate and improve, suppliers using data to improve their offerings, support for the trend of closed processes, clarity on the governance of single use and quality by design.

The Challenges of Moving from Stainless Steel

One of the most interesting elements of the conference were the multitude of case studies from companies who had made the transition from stainless steel to single use and had also scaled up such operations.

Olivia Li, Senior Engineer at Amgen, shared where some companies may push back in the single use transition, citing lack of prior risk assessments, the increased product risk, the need for operator training and the balance of capital versus operational cost.

Jean Yves Bauer, Senior Engineer at GSK Vaccines offered insight into how to accurately weigh up the financial viability of stainless versus single use when revamping a facility. He discussed hardware, piping and decontamination costs as well as recurring qualification, maintenance, deviations and the cost of disposables. As he recognized, both can be competitive options. However, it depends on a clear analysis of your needs and your willingness to invest in a transition.

Sharyn Farnsworth, Principal Scientist-Manager of Cell Culture at Fujifilm Diosynth Biotechnologies, also shared her lessons learned from scaling up multiple single use facilities. Her recommended best practices for single use design included; a centralized library of SKUs, a harmonized approach to the tendering process, avoiding excessive redundant connection and ensuring filtration rigs are adequately sized with safety margins included.

Continuous Manufacturing

A number of people were interested to hear more about continuous manufacturing in the biotechnology industry. The main drivers were seen to be flexibility, speed and process robustness. There was also a want to improve control over product quality and overcome bottlenecks in active pharmaceutical ingredient product.

Klaus Kaiser, Head of Downstream Processing at Bayer discussed a side-by-side performance comparability for batch versus continuous. He recognized the many advantages of continuous downstream manufacturing, such as; a fully automated process, shorter processing times, reduced costs, higher flexibility in product output and the same scale for clinical and commercial production. As he noted, a science and risk based approach is needed to define whether this is the right step for your process.  

Managing the Vendor/End User Relationship

The conference was a strong reflection of the collaboration happening within the industry between vendors and end users. There were many discussions during the event on how both sides can work together more effectively and drive better results.

Vendors were seeking greater transparency from end users on their exact applications and critical design considerations. It was also important for them to know how they can be competitive on projects and what is needed to differentiate their offering. Openness on project timelines and flexibility around prototypes was also recognized as significant.

On the end user side, many wanted to hear more from vendors about what was working within the industry and where they were seeing success. They also wanted vendors to take the time to fully explain their products and process to foster a more collaborative environment.

Having single points of contact across the process, maintaining communication and being clear about objectives and constraints during the project were all seen as critical factors for success.

Although the industry is facing a number of challenges, the collaborative energy, willingness to address difficult topics and push for innovation will surely lead to impactful progress.