Accelerating the path to first-in-human clinical trials

By Melissa Fassbender contact

- Last updated on GMT

(Image: Getty/Rost-9D)
(Image: Getty/Rost-9D)

Related tags: First-in-human, Clinical trials, Manufacturing, CDMO, Arcinova

On the path to first-in-human clinical trials one of the main challenges is “velocity, ensuring rapid delivery of delivered drug product into the clinical program,” says CDMO.

When asked about the challenges on the path to first-in-human clinical trials​, Arcinova Head of Drug Substance Paul Quigley – who will be discussing the topic next week at CPhI North America – said the rapid delivery of technically complex small molecule drug substance and drug product is pertinent: “[M]oreover, the development of scalable, economic, high purity and safe small molecule manufacturing processes is a key challenge,” ​he told us.

Read: FDA guidance on expansion cohort use in FIH trials a ‘welcome step’

“Many Biotechs have a need to ensure the achievement of reimbursable clinical milestones which heavily influence their ability to raise funds to support further clinical development phases,”​ Quigley added.

Arcinova is a UK-based contract development and manufacturing organization (CDMO) focused on the development of technologies, such as flow chemistry and synthetic biology, to shorten drug delivery timelines.

As part of this, the CDMO recently was able to use flow chemistry to compress three processing stages into a single operation, thus shortening the final drug substance delivery timelines by several months – and from 45 batches across eight stages of chemistry to six batches, in this particular case, said Quigley.

“Another example has been the use of genomics to development enzymes for remote chiral functionalization,”​ he explained, “which has removed a further four processing stages on the route from starting material to final drug substance.”

Single site benefits?

According to Quigley, there are "relatively few"​ fully-integrated CDMOs conducting all operations in parallel at one site. This includes chemistry, solid-state technology, analytical capacity, and formulation development.

Quigley said, “Biotech clients in particular value this one site offering where we function as their virtual development, scale-up and manufacturing partner using strong levels of expertise, capacity, and technological innovation.

“The Biotech community is proving to be a strong driver of the modern pharmaceutical industry. Biotech companies rely heavily on fundraising to progress their clinical trials to a point of commercialization, sale or out-licensing to a third party.”

A responsive production system

Arcinova this year was awarded​ a grant from the UK government grant to further develop its digital manufacturing platform. The funds will be used to purchase some key production equipment, including a new robotic capsule filing system from 3P Innovation Limited.

According to the company, it will be able to produce on-demand, specific therapies for small patient populations at an accelerated rate.

Currently, the production rate of patient-specific drug products is limited to 200 units per hour, according to the CDMO, which said this rate of production is due to the lack of automation. Using robotics, Arcinova said its platform can produce 1,000 units per hour.

“Digital technologies and automation enable a more responsive production system to efficiently and economically produce short runs of product on demand,”​ Gareth Jenkins, chief scientific officer, Arcinova, previously told us.

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