Streamlining Combination Product Development
SPONSORED CONTENT: Combining injection devices, primary containers, and fill/finish CDMO services under one collaborative framework, this approach is strategically beneficial for biopharma companies developing advanced combination products.
As advanced biologics and targeted drug delivery formats become more widespread, biopharma developers are being faced with increasing operational friction, trying to coordinate separate suppliers for primary packaging, device components, and fill/finish manufacturing. In efforts to resolve these coordination bottlenecks, Terumo has consolidated its capabilities under a unified service framework it terms ‘Deviceuticals™’.
“Deviceuticals™ — the combination of device and pharmaceutical products from the pharmaceutical industry or biotech — is for us the way to combine our services under the same umbrella,” remarked Isabelle Delcroix, VP Strategy and Marketing (former Strategy and Growth Initiative Director) for Terumo in an interview recorded during CPHI Milan with The Pharma Navigator. “We are combining our three platforms: injection devices with all our needle technologies, primary containers, and our fill/finish CDMO services.”
By bringing these three technical pillars under one management structure, service providers can offer biopharma sponsors a single operational interface, simplifying governance and de-risking the critical path to clinical supply Delcroix commented. “The main service we offer is an integrated single face to the customer to solve potential friction issues between different interfaces, which we see frequently in the industry,” Delcroix confirmed. “As that single point of contact, we offer smoother services under one program management framework — giving pharmaceutical companies a faster, quality-assured route to the patient.”
Application in Complex Modalities
The necessity of an integrated strategy for devices and primary containers is particularly evident for sensitive therapeutic areas, such as intravitreal and ophthalmic administration, Delcroix revealed. Should there be any particulate contamination or silicon oil droplets present within these therapies, there are significant safety and regulatory ramifications, she added.
“Let’s take an ophthalmic application for ocular injection,” Delcroix continued. “A pharmaceutical company would need a dedicated injection needle — such as our Injection Filter Needle (IFN), which contains an integrated filter to act as the final barrier against particulate matter before injection. That represents our first platform.”
Pairing specialized administration devices with tailored primary packaging further ensures product stability and patient safety prior to fill/finish, Delcroix noted. “Sponsors can also select from our second platform: a silicon-oil-free primary container specifically designed to minimize particulate injection into the eye,” she said. “We then execute fill/finish operations at our facilities in Japan or Germany, continuing through blister packaging and secondary assembly under single-source oversight.”
Accelerating Timelines
For innovators trying to balance clinical milestones, the integration of drug delivery hardware with final fill/finish under a single regulatory umbrella reduces lead times and simplifies quality assurance protocols, Delcroix explained. “We handle combination drug products up to final blister packaging all under our direct responsibility, creating a much smoother pathway for clients regarding supply chain management and quality assurance,” she summarized. “Ultimately providing a fast-track, quality-assured journey to the patient under the quality standards of Terumo.”
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