Applications of robotics in the pharmaceutical industry    

Reducing the time and cost of moving a drug from the lab to the clinic is one of the biggest challenges for pharma, taking 12–18 years on average, costing $2-3bn, and only having a 10% success rate. To accelerate the drug discovery process and increase accessibility for emerging drug discovery companies, Eli Lilly created the Lilly Life Sciences Studio Lab alongside Strateos, a leading cloud robotics vendor for pharma. 

The robotic lab is run with Strateos’s cloud robotics platform, with researchers able to control the lab via a web-based interface and track data in real-time. Including more than 100 instruments and storage for over five million compounds, the closed-loop robotic lab accelerates the design-make-test-analyse cycle by automating design, synthesis, purification, analysis, sample management, and hypothesis testing. In 2021, Eli Lilly revealed that the lab generated up to 20% of all the company’s compounds that go to a biological screening. 

There is a huge unmet need for the treatment of certain central nervous system (CNS) disorders, particularly those in the brain, as it is very difficult to precisely direct drugs to a particular area. Bionaut Labs is combining robotics with pharmacology to develop new therapies able to overcome this barrier.  

Its remote-controlled micro-robots, Bionauts, enable precise targeting to deliver therapeutics from gene therapy to oncolytic viruses. The Bionauts are untethered and remotely controlled by a magnetic propulsion system. Designed to move through fluid-filled spaces, the Bionauts can be directed to move, pierce tissue, and unload the contained therapeutics, before being safely directed back out of the patient.  

Before use, a magnetic resonance imaging (MRI) scan of the patient is taken to map out the intended path, and real-time X-rays mean that surgeons can ensure the Bionaut is in the correct position. Ranging in size from 100 microns to one millimetre, the Bionauts can have many different forms dependent on their intended function. 

Bionaut Labs is beginning with two focal areas for micro-surgical application. The first indication is for malignant gliomas and has received orphan drug designation from the FDA for its BNL-101 Bionaut in June 2021. BNL-101 can travel through the brain to deliver doxorubicin, a chemotherapy drug, directly into brain stem tumours.  

The minimally invasive procedure is combined with standard-of-care radiation therapy, and in vivo studies showed superior efficacy and survival. Gaining orphan drug designation approval for BNL-101 provides benefits such as assistance in the drug development process, tax credits, exemptions from certain fees, and seven years of marketing exclusivity.  

Since receiving orphan drug designation for BNL-101, Bionaut Labs has partnered with Candel Therapeutics, to deliver Candel’s oncolytic viruses to brain stem tumours with the Bionauts. 

Bionaut Labs’s second focus area is Dandy-Walker Syndrome (DWS), a congenital, paediatric condition. Current treatment targets the fluid-filled cysts that develop in the brain of those affected and involves inserting a tube into the brain to reduce pressure.  

However, the treatment comes with complications, especially for children as they grow. In September 2021, Bionaut Labs received humanitarian use device designation (HUD) from the FDA for a Bionaut designed to pierce the cysts in patients with DWS in a minimally invasive procedure. The HUD approval will significantly accelerate the pathway for market approval. Having tested the micro-robot on large mammals, Bionaut Labs aims to begin human proof-of-concept studies in 2024. 

To cover the costs of bringing a new device to market, and accelerate the process, Bionaut Labs has strategically chosen to target rare diseases, enabling its products to go through accelerated regulatory pathways, including HUD and orphan drug designation.  

DWS in particular is such a rare disease, affecting up to 1 in 25,000, that Bionaut Labs will be able to carry out an early feasibility study on up to five patients. Further safety data from Bionaut Labs’s clinical trials will serve to accelerate investment. 

The potential for cell therapy to eliminate, rather than reduce, cancerous cells is an extremely important avenue to advance the treatment of cancer. However, a major challenge in the cell therapy space is how products are manufactured. Many approaches use a patient’s own cells as a basis for modification.  

These must then be manipulated and expanded into a usable product. Establishing this manufacturing process across regions is a significant hurdle, alongside associated costs.  

To resolve this challenge, Multiply Labs established a consortium alongside Cytiva, Thermo Fisher Scientific, Charles River Laboratories, and the University of California San Francisco (UCSF) to automate the manufacturing of gene-modified cell therapies with a current Good Manufacturing Practice (CGMP)-compliant robotic manufacturing system at an industrial scale. 

The five members work together in collaboration to create one product. Multiply Labs provides expertise in cloud robotics, with products in its portfolio including robots for capsule manufacturing, capable of producing 30,000 drug capsules per day, and its QCmaestro automation software. 

Cytiva is automating bioreactor for cell therapy manufacturing, used in the manufacturing of market-approved chimeric antigen receptor T (CAR-T) cell therapies. Thermo Fisher Scientific is automating incubator technology, with the Heracell VIOS incubator able to control CO2 levels, humidity, and airflow.  

Charles River is automating quality control testing, with its Celsies Rapid Microbial Detection and Endosafe Endotoxin Testing platforms used for testing cell therapy products, reducing the final release testing of cell therapies from 14 days to three days.  

Finally, UCSF is overseeing the manufacturing process through a sponsored research agreement. The finished robotic system will reduce manufacturing bottlenecks and minimize human contamination, while also being adaptable and having a very high throughput. 

With the cell and gene therapy market set to increase at a CAGR of 36% from nearly $3bn in 2021 to $25bn in 2028, according to GlobalData forecasts, the consortium’s finalized robotic system could become the solution to cell therapy manufacturing issues and help to increase the affordability and accessibility of cell therapeutics.