Helping innovative companies get novel biological therapeutics to market

If you’ve had a vaccine, you’ve been treated with a biologic — a class of pharmaceutical therapies containing more established and innovative types of drugs. Biologics are large, complex molecules, and the active substance comes from a living organism, be that animal or microbial cells or from blood, tissue, or plants. 

Biologic products are often proteins consisting of hundreds or thousands of amino acids assembled inside living cells and modified for a particular use. This contrasts with small-molecule drugs, such as aspirin or paracetamol, which are generally less complex in structure and chemically manufactured in bulk. Beyond complexity, biologics are significantly more prominent, with a large biologic, such as a monoclonal antibody (mAb), more than 800 times the size of aspirin. 

The size and complexity of these products, including the biological variability introduced from the host cell or tissue, mean rigorous product separation, purification, and formulation processes are needed to ensure quality, safety, efficacy, batch consistency, and compliance. 

For this reason, scientists and engineers at CPI are constantly working to improve biologic manufacturing. In this article, we will explore the impact of biologics and how we can help pharma, academia, SMEs, and spin-outs at any point in the manufacturing process. 

Biologics are transforming medicine

Rapid advances in genomics and proteomics, the large-scale study of DNA or genes and proteins, have facilitated a boom in biologics. 

From groundbreaking COVID mRNA vaccines to human growth hormone and insulin — which have saved and extended the lives of tens of millions of diabetics — biologics have and continue to transform the landscape of medicine. 

mAb therapies are recombinant versions of naturally occurring antibodies that form part of our immune system and fight off infection. However, mAbs are designed to attack specific disease targets or infections. mAbs and other biologics offer promising treatment approaches for cancers and neurodegenerative diseases like Parkinson’s and Alzheimer’s.

The growth in biologics has increased market share through approvals from the US Food and Drug Administration (FDA) in 2022 for the first time. Biologics also figure strongly amongst the top 10 selling drugs, occupying the top 3 spots.

As the demand for new therapeutics grows, particularly with the advent of personalised medicine, biologics production must become faster, more efficient and cost-effective. 

Supporting the next generation of biomanufacturing processes

Biologics have highly complex biomanufacturing processes that require more time, testing and expense than is typically needed for small-molecule drugs. Because of this complexity, our expertise in critical areas can help speed up the development of processes for biologics manufacturing: 

• Technology benchmarking helps organisations evaluate their novel processes and analytical technologies against the current gold standards to refine, improve, and generate data for internal or external publication. This allows developers to understand product performance and identify gaps, catalysing the introduction of novel and potentially disruptive products to the market and driving manufacturing innovation. 
• Continuous manufacturing or processing creates a stream of products through an uninterrupted and automated process. Through continuous supply of raw materials and advanced process control, intermediates are continually transferred from one step to another so that finished drug products are continuously removed at the end of the pipeline. 
• High-throughput development helps scientists test countless possibilities through parallel comparison of different conditions on a small scale on automated robotic platforms. This reduces turnaround time and cost while improving process consistency. One example is our automated Ambr250 high-throughput perfusion parallel bioreactor system for cell culture and microbial fermentation development. 

Applying these methods leads to faster results, shorter wait times, lower costs and better biologics, resulting in the flow of these important medications to people who need them most. 

Partnering for innovation in biologics manufacturing with real-world impact

Science is built on collaboration. CPI exemplifies this through impactful collaborations with market leaders. For example, working in partnership, we led the development of an integrated solution for continuous processing therapies. Building on this, our UK Continuous 2 project built a fully continuous mAb manufacturing platform, which will help make products more accessible while improving the sustainability of biologic manufacturing. 

Another example is when Intract Pharma’s Soteria technology used our formulation facilities to develop the first capsule prototype for a specific mAb drug, infliximab, which is usually administered through infusions or injections. We were able to help the Soteria project consortium — with SGS Quay Pharma and Pharmidex — assess and optimise the processing parameters for large-scale manufacture of their oral product and conduct stability testing, which ultimately resulted in a proof-of-concept to take their infliximab product to clinical trials. 

We’ve also worked with 2 partners on synthetic DNA manufacturing processes. Unlike conventional DNA manufacturing, which has limitations in safety and cost, synthetic DNA production methods could help get genetic medicines to people faster and more safely. 

With 4BaseBio, a synthetic DNA manufacturer, we improved the speed of their production process and the quality of their DNA products by enhancing their purification and analytical processes. For Touchlight Genetics, another synthetic DNA manufacturer, we helped scale up its next-generation synthetic DNA manufacturing method. 

Let’s also note that although the pandemic was a testing time, the scientific advances that emerged from it have secured an enduring legacy. We worked with academia and the government to explore biological therapies to combat COVID-19. We worked on mRNA vaccine candidates as part of the UK Government’s vaccine taskforce. We secured further funding that resulted in opening our RNA Centre of Excellence – right next to our National Biologics Manufacturing Centre – as a hub for manufacturing RNA-based products. Together with Imperial College London and other partners in the UK BIA Antibody Taskforce, we supported the identification of novel antibodies that could be used to treat COVID-19. 

Our expertise in this field has extended to technology evaluations. We worked with Roche to optimise the yield and quality of mRNA products and with 908 devices, using their Rebel™ device to improve mAb titre and quality from bioreactor culture. Both will improve the processing and quality of biologics dependent on these systems. 

The potential of novel biologics is vast, and at CPI, we’re committed to turning innovative ideas into real-world treatments. By combining our expertise with the groundbreaking work of our partners, we’re pushing the boundaries of what’s possible in this field. 

Are you ready to accelerate your biologics journey?

Book a call today to discuss how we can support your specific needs.