The predictions vary for exactly how much the market for antibody drug conjugates (ADCs) will take off in the coming years, but one factor is the same for analysts — growth will be in the billions.
The allure of ADCs — especially in oncology — is apparent. Because the technology combines a selective monoclonal antibody (mAb) with a potent cytotoxic agent (stronger versions than those used in traditional chemotherapy) to attack diseased cells while avoiding healthy ones, ADCs offer a more efficient way to utilize therapeutic agents.
Yet, to date, only four ADCs have been approved by the U.S. FDA. And growth in the market has been stymied by fragmented supply chains, high costs and low efficiency associated with manufacturing. But this is where UK-based ADC BIO comes in.
Founded in 2010, ADC BIO is one of the few CMOs that specializes on ADCs. The company isn’t just focused on tapping into the increasingly lucrative market for ADCs — they’ve also solved one of the market’s major challenges by using patented technology to create a more integrated manufacturing approach.
CONSOLIDATING THE PROCESS
“One very clear message from our client base is that the supply chain for ADCs is too fragmented,” Charles Johnson, ADC BIO’s CEO, says. “You’ve effectively got three main buckets of production … done by different companies. What the industry would like to do is consolidate and move to fewer vendors in a more integrated supply chain.”
To achieve more parts of the manufacturing process under one roof, ADC BIO has patented a technology that undertakes bioconjugation after both the mAb and cytotoxic have been produced. The innovative approach moves conjugation upstream into the antibody manufacturing process, combining conjugation and antibody purification.
According to Johnson, this method — which moves two of the three parts of the process into one step — saves several months of manufacturing time and decreases the overall costs significantly.
The company’s groundbreaking production technique — yet to be formally named — would also remove the need for Protein A resins, instead replacing them with capture resins that are at the heart of the company’s core “Lock-Release” technology.
According to the company, their Lock-Release platform, “streamlines bioconjugation into four simple steps. Lock the mAb to a resin, perform the conjugation, wash the locked ADC free of residuals and then release the purified ADC. Originally developed to limit ADC aggregation and improve residual clearance when starting with purified mAbs — problems common with the emerging payload-linker classes — this technology has been a huge step forward for the industry.”
The company says the Lock-Release technology allows ADCs to be delivered to cancer cells with “unrivaled precision” and fewer side effects than traditional treatments.
So far, sales at ADC BIO have been solely generated by their technical services department, which works with drug developers on next-generation ADCs and biomolecule conjugates.
But, ADC BIO is currently in the process of transitioning from R&D to mainstream manufacturing. In 2017, the company put together a $11 million funding package to transform a pharmaceutical warehouse in north Wales into a manufacturing space. Johnson says that regulatory inspections on the facility, including the UK’s Medicines and Healthcare Products Regulatory Agency, will be completed in the first half of 2019, with production following in the second half of the year.
Going forward, Johnson says the company is also working with their existing design and build partner, who is a specialist in cleanroom technology, to conceptualize a formulation and filling operation that will be built under the same roof as its GMP conjugation infrastructure. ADC BIO will specifically be looking at liquid aseptic filling technology and plans to “future-proof” the design so that it can offer lyophilization services down the road.
Although the oncology market is set to continue as the main area of focus for ADC BIO, there is a lot of promise for this kind of treatment in other therapeutic areas such as inflammation, rheumatoid arthritis, anti-virals and more. And as the market expands, ADC BIO plans to stay at the forefront with its innovative approach to manufacturing.
“We certainly foresee a paradigm shift in how ADCs will be made in the next decade,” Johnson says. “It’s going to be a more elegant and integrated approach. That’s what’s really unique about what we are proposing to do.”