The breast cancer drug Herceptin and the rheumatoid arthritis drug Humira are breakthrough treatments in their respective areas. Both are also biologics or drugs that have been produced using genetically-engineered living or host cells.
Biologics are the future. However, they are also very costly and time-consuming to make, and this is where the Dublin-based lifesciences company Valitacell fits into the frame. It is offering pharma companies a novel method of transforming the complex manufacturing process that produces bio-therapeutic drugs by making it faster and more cost effective than it is today.
Evidence that the company is on the right track can be seen from its client list. The young startup has already attracted the attention of US conglomerate GE Healthcare, international biotech company MedImmune, which is part of Astra Zeneca, and global health company Grifols.
Biologics is a rapidly emerging specialist niche with huge growth potential. Estimated sales of biologics in 2016 were $210 billion (€175.2bn), with Herceptin contributing $7 billion (€5.8bn) and Humira $13 billion (€10.8bn) of that between them.
Valitacell employs 10 people, and is based at the National Institute for Bioprocessing Research and Training (NIBRT) on the UCD campus.
"Biologics are highly complex, and must be grown in host cells to deliver the bio-therapeutic required," says CEO Dr Terry McWade, who co-founded the company with Jerry Clifford in 2015.
“Let me give an example. A traditional small-molecule drug such as Aspirin has 21 atoms. The biologic Herceptin has 25,000. At the moment the problem is the huge volume of cells – over 2,000 – that need to be screened for their ability to produce the drug. This is where we come in.
“Our technology changes the way in which the cells are screened, and in so doing shortens the time needed to set up the production of a biologic drug by identifying the optimal host cell. At the moment companies currently test for stability over 160 days. We believe we can bring this back to 30-40 days.
“Our products also allow users to select cells with greater regulatory confidence at the earliest possible stage during the drug development pathway. In short, Valitacell is transforming the cell line development process with simple, robust technologies.”
The company’s launch product is Valita TITER, which was launched in February 2016. It provides customers with both the hardware to conduct testing (a coated 96-well plate) and the software (based on proprietary algorithms) to interpret the results.
“What’s really significant is that Valita TITER is providing companies with a simple, fast and cost-effective way of analysing host cells,” says McWade. “Currently testing involves expensive equipment, cumbersome sample preparation and the need to use centralised labs.
“Modern medicines are becoming increasingly complex, and biologics an increasing part of their creation. Our system addresses the typical bottlenecks found in existing systems, and offers an easy to use high-throughput alternative.”
The company’s current focus is the healthcare sector, but McWade says Valitacell’s technology can also be used in the food, beverages, cosmetics and fermentation industries.
“We started with pharma because it is so highly regulated that we felt that if we could prove our technology within this environment it would pave the way more easily into other sectors,” McWade says.
“We are already looking at a second solution, again with the aim of making the passage of drugs to market simpler, faster, cheaper and easily automated, which exiting technologies can’t do.
“Because you get results faster it speeds up the process, but you also get more capacity and this saves costs. There has been an explosion of molecular medicine so there is pressure to bring products forward. Costs have become important.”
Valitacell is working on future technologies with a number of academic research bodies, including the Fraunhofer Institute in Germany, the University of Sheffield and Celland Gene Therapy Catapult UK.
Development costs to date have been in excess of €1.7 million, and the company has been privately funded with support of €300,000 from Enterprise Ireland under its HPSU programme.
The company has recently won research funding of just over €2 million under Horizon 2020 (the EU’s innovative research programme for SMEs) and this will be used to fund the advance and commercialisation of Valitacell’s new ChemStress technology. The company expects to expand its workforce in the coming months, with jobs coming on steam in biological and chemical engineering, artificial intelligence, machine learning, assay development and biotechnology.