Changing scenarios, changing technologies: Biotech must get agile

Global Technology Partner, NNE

Morten Munk

Global Technology Partner, NNE

Morten Munk has 30 years of experience within the biopharmaceutical industry and has wide experience from pharma projects in Asia, South America, USA and Europe.

Munk is actively involved in international industry organisations such as ISPE and PDA. Furthermore, he is appointed as member of scientific committees for various international conferences, as well as a member of the CMC Biologics Technical Advisory Committee, PDA Biotechnology Advisory Board and Advisory Board for Master studies at Copenhagen University on Industrial Drug Development and Regulatory Affairs.

Munk holds a degree in chemical engineering from the Technical University of Denmark. In 2001, he co-founded CMC Biologics A/S and held a position as vice president for business development at the company before joining NNE in 2015. Prior to this, he was principal scientist at Novo Nordisk, responsible for the chemistry, manufacturing and control development part of several projects, including development of the slow acting insulin analogue, Levemir®.

Pipelines are increasingly diverse and volume demands uncertain. How can biotech players stay afloat in this changeable manufacturing landscape?

Biotech is moving beyond the traditional “one drug, one protein, one disease” paradigm to pipelines with multiple sophisticated new drug modalities. These include complex versions of traditional protein based molecules – such as enzymes, hormones, monoclonal antibodies and fusion proteins over antibody-drug conjugates (ADCs) – and the quickly evolving area of cell therapy. The ability to gain deep biological insight into complicated diseases and tackle them with sophisticated, specifically engineered drugs will save millions of lives worldwide.

To adapt to this change, biotech manufacturers will increasingly face new business scenarios. As positive as these developments are, they also mean more product variation, uncertainty around capacity and a need to stay on top of different regulatory requirements. In addition, society is changing. People are increasingly focused on environmental sustainability and smart workplace design to improve employee wellbeing.

Taking these factors into consideration, the biotech manufacturing industry must be increasingly flexible to cope with shifting demands. Reacting to these changes by finding the right combination of new technologies and agile manufacturing techniques is key.

The impact of business changes on biotech manufacturers

One scenario is dealing with the urgent need to increase the output of an established facility. This means increased run rates, increased intensity and yield and the need to build additional capacity. Ultimately, a manufacturer would need to find the right technology to up the production capacity in the most cost efficient way.

However, there may at some point be less need for this product, or the need for the product may be delayed. A manufacturer would then need to reduce the run rate and potentially introduce new products to the pipeline. This would increase their focus on flexibility and producing smaller yields.

In a multiproduct scenario, there would be a need to produce additional products and clinical material. To do so a manufacturer would need to think about tech transfer and fast changeover.

Finally, perhaps a manufacturer needs to focus more on health, safety and the environment. They would then need to find ways to reduce environmental impact while improving employee wellbeing without disrupting operations on a large scale.

What’s the right combination? Leveraging technology and agile manufacturing

Different facility types, from large-scale stainless steel fed batch to small scale personalised medicine, can leverage different technologies to cope with these changes – including titer increases, single use, continuous and closed processing, process intensification, PAT, digitalisation and robotics.

For example, stainless steel technology platforms offer a high volume output and increase efficiency, whereas single-use technology platforms are lower volume, more flexible and can be localised to a specific market.

Utilising a modular approach increases the flexibility of a building, as well as the execution and operational methods, offering the opportunity to adapt quickly to changing demands.  This includes:

  • Fast-track project execution
  • Modular processes
  • Installation-friendly buildings
  • Integrated teams
  • ASTM-E2500 verification

Ultimately, it is paramount to remember – what may make sense today may become a stumbling block in the future. The key is to investigate a broad array of different scenarios and find the right combination of technologies that address both your current needs and allow you to stay agile and switch up your approach if business needs change.