Interview with Beate Müller-Tiemann | CTO of Cytiva

ACHEMA Inspire: This is still a young industry, but one that has revolutionized medicine in only a few decades. How far do think it has come in that time?

•  __The biopharma Industry has indeed been pioneering many breakthrough technologies and setting standards in unprecedented territory for decades. For example, recombinant technologies improve patient safety, replacing protein drugs purified from human or animal tissues, such as recombinant human insulin or recombinant blood factors.
  
  Overall, I'd say the biopharma Industry has been able to demonstrate a remarkably quick adoption and assimilation of the leading-edge discovery and manufacturing technologies. In particular, the in-vitro creation of monoclonal antibodies, into pharmaceutical applications.
  
  This has resulted in the first recombinant antibody drugs such as Herceptin or Humira, being able to address unmet medical needs. This revolution was enabled by the collaboration of academia, biotech, large pharma companies and regulatory authorities - all working in lockstep for the benefit of patients.
  
  The biopharma industry and its ecosystem has revealed its full unleashed innovation power, meaning unprecedented speed, agility and true purpose during the Covid-19 pandemic. This is now spurring the progress of the industry in new territories like mRNA-based pharmaceuticals and vaccines, oligonucleotide drugs and therapies.
  
  The cell and gene therapies, in particular, have truly changed patients’ and their families lives for the better. Regenerative medicines will also undergo a paradigm shift with new cell therapies entering clinical development. Let's not forget, digital tools will also play a major part, changing our industry even more, not to mention faster, moving forward.

ACHEMA Inspire: Moving to the present, Cytiva’s recent Resilience Report was its most extensive yet. But what picture do you think the results paint for the industry?

•  __The overall 2023 Global Biopharma Resilience score is 6.08, which is lower than the 2021 score of 6.60. This decrease could be a result of a broader data set, including publicly available data on biopharma trends, and offers a more extensive overview of the industry.
  
  In some areas such as Biopharma manufacturing, the industry keeps maturing as 33 per cent of respondents say that it has become more affordable to manufacture biopharmaceuticals and 21 per cent of pharma leaders surveyed are expecting to see a dramatic increase in biologics manufacturing capacity in the next three years.
  In line with this, the supply chain for biologics are stabilising. Supply chains for biopharmaceuticals are still quite global because half of respondents say their country is moderately to highly dependent on the import of many inputs to drug production, as well as the importing of finished pharmaceutical products. The Resilience Report also speaks to the fact that the Biopharma industry is entrenched in the challenges of pioneering in the new modalities like cell and gene therapies where new standards have to be developed in collaboration with regulators, which is illustrated by the fact that 52 per cent of executives believe agencies are not good at ensuring availability of specialist pathways for cell and gene therapies.
  
  When it comes to the issue of talent, it's worth noting that nearly 25 per cent of pharma executives report that it’s a substantial challenge to find and retain manufacturing talent. This problem is exacerbated by the increasing blend of AI modeling with research, which means that many companies are looking for a more specific skillset than ever before.
  
  The report then goes on to highlight the fact that the top three most difficult skills to attract and retain in the Biopharma Industry are GMP-Manufacturing talent, R&D talent and Digital technology talent. This represents a call for action on training and education in this space!

ACHEMA Inspire: Given that the next generation will involve unprecedented levels of Smart thinking, what do you see as the key challenges?

•  __If by Smart thinking you mean innovative thinking: Innovation always happens at the interface of disciplines. In the new modalities disciplines like Molecular Biology, Cell Biology, Virology, Biologics Process Development, Data Science and Engineering which must work closely together to innovate in the field of Nucleic Acid Therapeutics or Medicine, synthetic biology, Process Development and Engineering in the field of cell therapies. Only such interdisciplinarity will ensure the continued progress of the field.
  
  If by Smart thinking you mean digital tools, we are focused on four key technology advances to solve the industry challenges. They are In-Silico process development to speed development of high-performance and scaleable processes and predictive batch, to reduce frequency of failed or underperforming batches.
  
  There is also a focus on overall equipment effectiveness to decrease customer downtime via predictive and remote maintenance; and adaptive plant, to reduce transfer cost where, for example, Cytiva’s Virtual Reality training systems allow our personnel to learn processes virtually in advance of doing the job.

ACHEMA Inspire: With the drive for more biopharma products comes the need for the machinery to fulfill that. How well-placed is the industry to meet such demands?

•  __The ability to flexibly scale up or down manufacturing at short notice is a key factor in resilience. However, many countries have a limited ability to do this. The main factors impeding manufacturing operations include the technological capacity of manufacturing equipment, a lack of manufacturing talent and a lack of other skills within companies and agility among suppliers. There is also a need for regulatory approval. Cell and gene therapy manufacturing is still a very complex area and there is currently a limited amount of standardisation, making it difficult to scale up to meet the demands of a large patient population.
  
  Having said that, advanced digital technologies such as AI, robotics, and automation have the potential to give a major boost to manufacturing helping manufacturers to scale up or down on demand. But in general, the more mature a technology platform, the better equipped is the discovery, development and manufacturing toolbox as we are able to observe for the current generation of recombinant monoclonal antibodies. Concerning the new modalities, such as nucleic acid therapeutics and cell and gene therapy, the platforms are still developing as is the toolbox. So as things stand, there is plenty of space for innovation at the interface of Biology, Engineering and Digital Technologies to make the development and manufacturing of these new modalities cost-effective and robust.

ACHEMA Inspire: On a personal note, you’re known to encourage diversity in terms of teams and your approach. How will that thinking benefit any drive towards change in the sector specifically?

•  __Working across disciplines is key for innovation. Collaborations can and should happen among areas which might have previously been perceived as so different and far away from each other that there is no point in engaging. This diversity in background, thinking and approach will result in breakthroughs needed in manufacturing new modalities.
  
  Exposing, for example, chemical or biotechnology engineers to medical doctors and hospital staff in cell and gene therapy, might enable solutions for bedside manufacturing that result in paradigm shifts as to how biopharma is approaching its supply chains.

ACHEMA Inspire: As a Board member of Dechema, what are your drivers to engage?

•  __Dechema is a very influential and traditional institution in Germany and Europe. With its various technical and scientific disciplines, it is in a good position to fuel innovation in Germany, but the potential of the necessary interdisciplinary approach still needs to be leveraged. This is my mission as a Dechema Board Member.