Catalent and Bend Research have joined forces to tackle time and cost restrictions for the complex oral controlled-release development and manufacturing process.
Under the deal, Bend will provide its formulation development expertise, whilst Catalent brings its analytical, CMC (chemistry manufacturing controls), solid-state optimisation, as well as its clinical and commercial supply services, to the table.
Bend’s VP Trevor Wigle told Outsourcing-Pharma.com: “Because of the unique skill sets of the two companies, this alliance should result in two main benefits.
“Firstly the identification and advancement of formulations with optimal therapeutic and release profiles, and improved efficiency in bringing formulations to market. And secondly reducing development time and risk and streamlining scale-up and manufacture.”
The firms now say they will leverage both their own capabilities and those of other companies in a bid to deliver end-to-end services for multiparticulate oral development. As such, the pair are developing joint operations and tech transfer programs.
“We will work hard to establish relationships with companies that share our commitment to excellence, superior customer service, and clear communication,” he said.
He said that QbD (quality by design) principles will be the key focus when working with developers.
Wigle added that the firms hope the move will be the start of a “long-term working relationship” which will provide Bend’s clients with access to Catalent’s manufacturing capabilities.
In a statement, Catalent’s president of modified release technologies, Ian Muir, said Bend’s lab-scale modeling expertise will be a boon for its customers.
“This should enable optimal and seamless scale-up within Catalent’s controlled release network, and particularly at our Winchester, Kentucky facility, which is widely regarded as the leading commercial facility for multiparticulate products,” he said.
Work in progress
Of the type of client the new partnership hopes to serve, Wigle told us anything from Big Pharma to small biotechs will be targeted.
“We seek our partners based on our mission of advancing best-in-class medicines and working with quality companies that have difficult drug‑delivery problems to solve,” he added.
He also said that those hoping to form a relationship with the partnership would benefit most from a “collaborative alliance” under which multiple projects are carried out.
“We have found that by working on multiple projects, we gain a deeper understanding of the company’s culture and needs. In this way, we can provide even better solutions to the problems they face.”
Speaking about the type of demand for oral controlled-release formulations he expects will be most common in the future, Wigle said: “Two particularly promising areas of research to meet industry demand are the combination of controlled release drug delivery methods with solubilisation technology to improve the bioavailabity of drugs with low aqueous solubility.
“Also, strategies focused on reducing development time and costs to enable an increase in adoption for new chemical entities (NCEs) or reduced 505B2 – relying on information which you do not own or have right of reference to – development costs.”