Built for Change

The rapid rise of new manufacturing modalities, such as viral vectors to mRNA vaccines, is coinciding with a digital revolution in how we work.
Only a holistic approach will allow companies to overcome the challenges and seize the opportunities.

If there’s one phrase I might use to describe how I feel about the industry today, it’s “cautious excitement.” Monoclonal antibodies are still king in biotech and remain the biggest selling drugs in the world. We also know a lot about them; we know how to design, develop, and manufacture them efficiently and they are not going away any time soon. But there are many diseases that monoclonal antibodies or even recombinant protein therapies are not well suited to treat – such as more severe diseases with very small patient populations. This is the space now being filled by gene therapy. We have seen some truly exciting successes and it’s clear that viral vectors are also here to stay; however, there is a bottleneck in terms of manufacturing capacity that is limiting the development of gene therapies. How will the industry cope with the increasing demand given the relatively low process yields, high cost of goods, and suboptimal unit operations?
The trend towards more advanced manufacturing technologies has come hand-in-hand with the development of mRNA vaccines – from both Pfizer and Moderna as examples. The investment in this area has been enormous and the pace of development unprecedented, and it is serving to invigorate and inspire the industry. Many companies are thinking, “If we can do this, what else can we do?” Companies should also be thinking about the kinds of capacity and knowledge base they need to build as newer modalities continue to emerge. All too often, companies have to turn to academia to understand some of the technology.
When I was working in contract manufacturing – over two decades ago – it was difficult to make a monoclonal antibody because there weren’t many people in the world who knew how to do it. We are now seeing a similar situation with viral vectors. There is a lack of experience. But we’ve been through this journey before and I firmly believe that the industry will find a way to move forward. Two decades ago, we were all asking how we would be able to meet the high demand for monoclonal antibodies because it seemed that there wasn’t enough raw material in the world to bring these therapies to patients. But we did it. And we will also figure out the challenges in viral vectors and other emerging modalities; not just the manufacturing hurdles, but also the challenges associated with the supply chain. The early stages of the COVID-19 pandemic illustrated the importance of supply chain redundancy, which will continue to be key as long-term demand trends upwards.
Despite analogies with monoclonals, I think it will take significantly less than two decades to overcome current issues; first, because we have past lessons to learn from, and second, because there is so much attention and investment being poured into the field.
And it isn’t just new modalities that companies must be ready for; we must also cope with new ways of working. We’ve all had to adapt to virtual working, for example. Now, the challenge is finding the right balance between virtual and inperson work. We’ve been hearing from customers, especially bigger companies, how difficult it was to coordinate globally and realize tech transfer at all their manufacturing sites across the world – even in the same country. Prior to COVID-19, companies were sending armies of people to various sites to help implement new technologies and processes – clearly, expensive and time consuming. Today, virtual technologies – especially augmented reality – allow some aspects of tech transfer to happen remotely. And though travel will return to everyday business life, perhaps we don’t need to send 20 people across the world; companies can choose to send a handful of project managers while everyone else works virtually.
The benefit with change can often be increased efficiency, which at the end of the day will help the industry to bring drugs to market more quickly. We’ll be able to respond to demands faster and reduce lags in approvals. Tasks that used to take two years are going to take six months. It’s exciting, but companies must be ready for the change or risk being left behind.

Staying one step ahead
How is Pall keeping pace with biotech’s shifting tides? We continue to develop our equipment platforms in numerous ways, including making them easier to integrate. And that means more standardization of components and systems, as well as the use of automated platforms. We want our process engineers spending more time on process engineering and less time on working out how to get all the pieces of the puzzle to fit together, which allows us to spend more time with customers to help them understand their process and ensure it is reliable, sustainable, and efficient.
We will continue to invest in process development services to help customers, which in turn will also help us understand how customers are using our systems – and what new systems they need. We also want to continue to build our team of field scientists, which brings us even closer to our customers.
At Pall, we have learned to adapt to change. Pall was acquired by Danaher in 2015. Such a big change can bring uncertainty and potential upheaval, but I am excited to see how Pall is integrating Danaher’s rigor and market knowledge into processes. Danaher acquired a high-performing organization in 2015, but now we can be totally sure that we’re going in the right direction – reading the market correctly, developing the right products, and running plants as efficiently as we can. Ultimately, we can offer our customers
even more value.
When we bring a product to market, our customers can be assured that we haven’t just developed a really interesting new piece of technology for its own sake; there’s a certain quality and reliability built into the product from the very beginning. For example, we will do all of the necessary work to ensure the supply chain can support the new product, and we will have all the documents the customer needs to support validation and to get the product into the process. This information is all accessed very easily via a portal, as opposed to sending dozens of emails to different people to obtain the information.
We’ve also applied that rigor all the way through the customer process to ensure the right training materials are available, and that we have the right people to ease the process and support the implementation of the product for our customers. I think what the customer starts to see is a much more robust interaction with Pall across the entire lifecycle of the product. We’ve done all the work up front so customers can spend their time focusing on building up their processes – without any surprises!
Of course, there’s more change coming with Cytiva joining Pall under the Danaher umbrella. Fortunately, we’re both very customer focused organizations – in fact, I worked for the company that became Cytiva before joining Pall, so I understand both companies. We’re already figuring out how to put Pall and Cytiva systems together to create more complete solutions to support both traditional biopharma and the new modalities that are fueling intense activity in the industry. Both companies have tremendous bioprocessing expertise, so that’s really exciting.
And there’s still more great news coming out of Pall. Towards the end of 2020, we started building a new manufacturing facility in South Carolina; it’s almost fully functional and it will bring a lot of single-use capacity online. We’ve also acquired a manufacturing venture in China, as well as adding a substantial facility in the US. You may be surprised to know that we are approaching four times the total capacity that we had this time in 2020!
For Pall to exist as a real driving force in a rapidly evolving industry, we recognize we have to think about the whole ecosystem. We can’t fully support a customer if we’re focused solely on the supply chain or building the next new product. A holistic end-to-end view is crucial to ensure the customer is supported at every step.

Morgan Norris is the Vice President of Marketing at Pall. He is responsible for the strategy, outbound marketing, branding and product portfolio for the business unit. Morgan is a respected leader in the biopharmaceutical manufacturing space with over two decades of experience in biotech and pharmaceutical manufacturing. Morgan’s experience spans originator companies, contract manufacturing and suppliers with roles in technical, strategy, product management, marketing and business leadership. When he is not working or traveling Morgan enjoys spending time on the water, and at home with his young family.

Created by and originally published by The Medicine Maker

 



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