• Pharma Fluid Handling
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The Future of Bioprocessing and Single-Use Technology

An interview with Bioprocessing Expert Ralph Daumke

By Daniel Prause,

RAUMEDIC had the chance to sit down for an interview with Ralph Daumke.

Ralph Daumke

Ralph Daumke is an expert in single-use applications for bioprocessing. Currently a Market Manager for Pendotech by profession, he also volunteers as member of the board of directors of the globally active Bio-Processing Systems Alliance (BPSA) as well as for DECHEMA’s expert group on Single-Use Technologies for biobased applications.

With a degree in biotechnology, including a stay at the world-renowned Massachusetts Institute of Technology (MIT) during his course of study, Ralph is an expert on single-use systems for upstream and downstream processing in the development and production of biopharmaceuticals. 

Ralph, with your extensive background in biotechnology, and your roles in BPSA and DECHEMA, how do you view the future of the market for single-use bioprocessing equipment?

“The market is shifting from a hype phase to normalization.” – Ralph Daumke on the current state of the market for sing-use bioprocessing equipment.

The market is shifting from a hype phase to normalization. The hype was largely based on the COVID-19 pandemic, which turned out to be a boost for the industry due to the unprecedented global demand for vaccines. 

Due to uncertainty caused by disrupted supply chains and a scarcity of single-use equipment, everyone tried to stack up on scarce products in order to avoid production standstills.

So, now we’re entering a phase of “normalization”? What does that mean?

Despite a few turbulent years, analysts expect a steadily growing market. This matches with both my personal observations – and the experiences of many of my colleagues and network partners.

Overall, the biopharmaceutical and biotechnological industries have shown remarkable resilience and continues to innovate, which is key to its future success. These are good news for suppliers: the best is yet to come!

The United States accounts for the largest share of the biopharmaceutical market. As the importance of this market is expected to grow, will Europe be left out – as we’ve seen with other major economic trends?

Biopharma is a global business. Just like the well-known "big pharma" companies, major biopharmaceutical companies are also multinational entities. This global presence is particularly relevant in Europe, where the continent's needs for biopharmaceuticals and related supplies, including single-use equipment, are met both locally and internationally. 

With the growth of European pharmaceutical companies, there's an emerging trend towards developing a local supplier industry. This means that as biopharmaceutical firms expand, there's a parallel growth in the local supply chains to support operations.

If suppliers are growing along with biopharma as a partner industry, what should they know about biopharma? Or put in another way: What should they definitely know not to do when trying to partner up with industry representatives?

I cannot stress enough the importance of deeply understanding every customer's specific bioprocesses on an individual level. This is truly the only way to offer precise solutions tailored to their specific issues, rather than inappropriate ones that make suppliers look like they just want to make a sale without having understood the needs of the customer.

Being involved from the onset of product selection, before a process is established at the customer's site, is vital; altering a validated process is nearly impossible. Knowledge of clients' operations, upcoming plans, and how one's products can support these plans is essential.

Ralph Daumke stressing the importance of understanding customers on a personal level – and truly appreciating the individual problems they need to solve.

That seems like a challenging task. Who then should someone truly interested in finding out this crucial information talk to?

The focus should be on engaging with technicians rather than supply chain or purchasing departments initially, as technical merits are paramount. Purchasing decisions, especially in global procurement for multinational corporations, come later and are influenced by the technical advantages presented.

And on a product level? What are the “must haves” for suppliers – and how do their products generate buzz in the market?

In the context of "me-too" products, presence, quick sample dispatch, and unique selling propositions (USPs) that distinguish products are crucial. The availability and prompt delivery of components can significantly impact customer satisfaction. 

Moreover, technical specifications of products are critically important, highlighting the need for comprehensive understanding and communication in sales strategies to effectively meet and support customer requirements in the bioprocessing.

You previously talked about the issue of supply chains during the COVID-19 pandemic. From your perspective, have biopharma and biotech shifted their approach to procurement?

Frankly, it’s hard to predict what the most prevalent strategy will be in the future. In the past, there was a clear tendency to prioritize just-in-time deliveries, with quick response and shipping times being crucial.

During and after COVID, everyone stocked their warehouses with enough equipment – so that bioprocesses were not threatened. All I can say is that companies have learned from the shock of the pandemic and are better equipped for similar situations in the future. 

Now that we’re entering a phase of normalization in the industry, what are some current topics everyone is talking about at network gatherings? Can you list two or three things that always seem to come up?

Delivery times remain a challenge. Also, sustainability initiatives are increasingly pursued -but mostly at the corporate level. The threat of a PFAS (per- and polyfluoroalkyl substances) ban continues to be a concern. Further, making processes more efficient and faster through automation, although implementation is complex. 

Standardization is another a recurring topic, but difficult to achieve without significant pressure from customers or regulatory bodies like the FDA or the EMA, as manufacturers may be reluctant to voluntarily forego revenue that could be lost through standardization. Beyond these broader issues, the industry always faces specific technical challenges that require targeted and tailored solutions.

One of the big hopes put in biopharma is the prospect of treatments tailored to patients’ needs – going so far as to allow for truly individualized medicine. Does this prospect already affect the manufacturing of biopharmaceuticals?

“There’s a movement away from chemically based pharmaceuticals - towards biopharmaceuticals in smaller batch sizes” – Ralph Daumke on the future prospects of individualized medicine.

There’s a movement towards more individualized treatments that correlates with a pivot away - from the exclusively “mass produced” chemically based pharmaceuticals towards biopharmaceuticals in smaller batch sizes, e.g. 100 liters. 

However, the so-called “blockbuster” campaigns of producing large batch sizes of a single (bio)pharmaceutical are expected to stay around for a long time.

One key aspect of producing at smaller scale is automation. You’ve previously mentioned automation. What is the state of automation in bioprocessing – and how does it compare to other industries?

In bioprocessing, automation spans upstream to downstream, notably in cell culture and harvesting. Big pharma leverages large, minimally manned automation lines. While process monitoring sees partial automation, full process automation remains aspirational. 

When automation is implemented, it tends to be highly customized to each company’s setup, indicating a need for tailored solutions to meet specific operational needs. This highlights the ongoing evolution towards more efficient, automated biopharmaceutical manufacturing processes, though it also underscores the complexity and customization required to integrate automation across the entire manufacturing process.

You also touched upon sustainability. Could you expand on the role of sustainability in the context of single-use equipment?

Sustainability is still primarily a corporate-level concern, but has become increasingly critical in recent years, especially for purchasing departments. While engineers and technical specialists are still most concerned with finding the best technical solutions for their specific challenge, purchasing departments are increasingly tasked with finding sustainable product solutions to purchase.

As buyers are placing greater emphasis on sustainability, it is essential for companies to integrate sustainable practices to fulfill customer requirements and stay competitive in the market. This shift indicates a broader recognition the importance of sustainability.

Ralph, before we finish, we want to give you a chance to tell readers more about BPSA. Why do you think it is important for businesses across the value chain of single-use technology for bioprocessing to at least explore what BPSA has to offer? 

BPSA plays a crucial role in the single-use technology space for bioprocessing, offering a vast network for everyone involved—from suppliers to end-users. It provides an exceptional platform for companies to enhance their visibility, engaging in active participation in meetings, and leveraging networking opportunities to boost brand awareness and forge business connections. 

BPSA has various committees and offers an annual summit where various topics from the single-use sector are discussed. Additionally, the organization publishes valuable papers available to the public – for download on BPSA’s website. This allows members to contribute knowledge and gain recognition through collaboration on white papers, with their company names featured on these publications.  BPSA also offers training sessions, webinars, and more exchange.

It’s a unique opportunity for direct engagement with industry experts, making it indispensable for businesses in the single-use bioprocessing field to explore what BPSA has to offer.

A definite highlight is also the annual BPSA International Single-Use Summit. The next one will take place from July 22-24 in Washington, D.C. I would recommend anyone who is professionally involved in the relevant business field to check out the BPSA website and discover everything this organization has to offer.

RAUMEDIC expresses its gratitude to Ralph Daumke for taking the time to sit down for this interview and share his valuable insights. 

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