Vaccines, biotherapeutics and… cellular meat?!

Oral Monoclonal Antibody Treatment for Crohn’s Disease

Crohn’s disease is a type of inflammatory bowel disease (IBD) in which the immune system attacks the body, resulting in the long-term impairment of the digestive system through chronic inflammation. There are currently no known cures for inflammatory bowel disease, including Crohn’s, however, the chronic condition can be managed using therapies involving monoclonal antibodies which work by keeping the immune system under control.

Infliximab is a successfully marketed mAb used to relieve the symptoms of Crohn’s. Due to monoclonal antibodies being unstable in the digestive system, inflammatory bowel disease therapies are administered in hospitals via intravenous (IV) infusion or injections. Although this method of delivery is effective, it is also time-consuming, invasive, and often inconvenient for the patient. Oral monoclonal antibodies have the potential to be life-changing by enabling a less invasive and painless therapy for individuals suffering from an inflammatory bowel disease.

In a project led by Intract Pharma, CPI collaborated with SGS Quay Pharma and Pharmidex to develop the first-ever oral formulation of infliximab. CPI played an important part in determining process parameters for the large-scale manufacture of an oral infliximab capsule product, characterising the infliximab in the final drug product, assessing the stability of the drug product under varying conditions, and providing Intract Pharma with a successful process to take the oral infliximab to clinical trials.

In summary, CPI helped to accelerate this novel treatment to clinical trials, making Intract Pharma’s dream of their oral infliximab being used to help people living with an IBD one step closer to coming true.

Growth Media for Cultured Meat Production

Farming animals for food products is the cause of 51% of all greenhouse gases. By creating animal-based products from cell culture as an alternative, it will help to meet the consumer demand for meat alternatives which is quickly growing. On top of this, cellular agriculture is considered by many to be both more ethical and more sustainable than traditional meat production.

In order to successfully produce cultured meat in the lab, several essential nutrients are required to support the growth of the cells. Traditional growth media that is often used is Fetal Bovine Serum which is produced from the blood taken from foetuses of pregnant cows when they are slaughtered. Using this component in cellular agriculture prevents the product from being truly animal-free and therefore creates an ethical barrier.

We helped 3D Bio-Tissues with their cellular meat production by developing a high-throughput screening platform using our robotic liquid handling system to test the impact of different macromolecules in order to see how they affected the growth of animal cells and tissues. We then identified the best macromolecules that encouraged the cells to grow the most and helped to reduce the time it took to create a growth media product that is ready for the commercial market.

As a result of CPI’s help, 3D Bio-Tissues has been able to create an eco-friendly, animal-free and cost-effective growth media product for the cellular agriculture of animal-based products, known commercially as City-Mix Supplements. To date, there are five different types of this product that are available which support various cell types and applications.

RNA Vaccine in Response to the COVID-19 Pandemic COVID-19 affected all of our lives in some way or another. The whole world came to a halt, teaching moved online and there was a national shortage of toilet paper! The world was required to respond rapidly to the coronavirus outbreak and CPI played a helping hand in that by aiding Imperial College London in their development of an RNA vaccine.

Vaccines prepare your immune system to recognise and respond to invading pathogens, including viruses. Traditional vaccines use very small or inactivated doses of disease-causing pathogens so that when you are infected by the real thing, your immune system can quickly recognise and destroy them before the disease is caused or lessen the severity of disease symptoms. The world of vaccines does not stop with the traditional ones though; over the last decade, the interest in DNA/RNA-based vaccines has increased and more recently, has started to take this space by storm.

CPI Biologics worked alongside Imperial College London to help them develop their messenger RNA (mRNA) vaccine using self-amplifying RNA (saRNA).

We developed a process that successfully made 4 litres of saRNA (the largest scale saRNA vaccine manufacture in the UK!!) and worked with one of our other business units (CPI Formulation) to package the saRNA into lipid nanoparticles (LNPs) to enable the pre-clinical studies. We are also still supporting the UK Government in developing an RNA manufacturing capability in the UK, equipping the UK to respond rapidly to a pandemic.

The case studies discussed in this article are just the tip of CPI’s iceberg. There is an entire assortment of research and amazing products that will improve the lives of many, still in the process of being uncovered!