Under the deal – which the team says was helped along by Outsourcing-Pharma.com’s recent piece on merging research and manufacturing operations! – Gallus will provide large molecule manufacturing from the small scale volumes needed for clinical trials, up to larger production lines for marketed drugs. Theorem will provide development services.
Theorem’s CEO John Pothoff told us the alliance will target clients in emerging industries who want a quick route to US regulatory approval without paying out for a large amount of product.
“What’s driven the partnership between Theorem and Gallus is a demand from many of our clients, specifically smaller clients and clients from outside the US who want to enter the US biologics market, specifically emerging markets,” he said.
He added that Gallus’ “sweet space” capabilities – in which a customer effectively has a dedicated scalable section of the production space under the contract manufacturing deal – allows clients to run an entire project from development to marketing.
Pothoff said: “It means that Gallus can produce just the right amount for the trial, unlike other companies who don’t have that technology to produce small scale, which means that developers end up having to pay to produce larger batches than needed.”
And though he admitted the initial outlay could cost more than producing an overly large batch in an emerging market, manufacturing the product in a US facility with a strong regulatory approval history means accelerated market access, and is hence more cost efficient in the long run.
Gallus President and CEO Mark Bamforth said the main intent is to make the process as “seamless” as possible.
Promising prospects
Pothoff also told us that the most interesting biotech customers for the partnership at present reside in India and Latin America, which he said is a “resurging market”.
He added: “We’ve so far had a high level of interest from India and have Theorem and Gallus have together spoken to a lot of customers so far.”
Pothoff also said the service would be useful for small start-up biotech firms looking for a way to produce drugs for development, but that with any project, the firm wants in early.
“We’ll offer a solution if we can be involved with the project early enough,” he said. “Being involved early helps us to understand where companies are going and where we could jump in and help.”
However the service is not exclusive to those developing drugs he added, and said an increasing industry focus on orphan indications has led to the need for smaller volume production.
“In long term manufacturing following approval, the ability to do smaller manufacturing makes sense,” he said.