By Louis Garguilo, Chief Editor, Outsourced Pharma
A report from the BioPhorum Development Group (BPDG) includes interesting findings on the outsourcing habits of “platform”-focused biopharmaceutical companies when it comes to analytical development.
Being that here at Outsourced Pharma we’ve often heard a lack of analytical-support services at CDMOs has been a long-endured challenge for drug sponsors – and especially emerging biopharma – I decided to give this a little more thought.
Emerging biotech and Big Pharma alike often invoke advantages of their “platform” when talking to investors, industry partners, regulatory bodies, and any others about their drug development and manufacturing activities and pipeline.
If an emerging biopharma, you are attempting to establish a unique, systemic approach different from competitor drug developers, and setting your organization up for potential commercial success (where others may have failed).
If an established pharma, you are efficiently building on past successes and core competencies to continue to fill your pipeline; yours is a systematic methodology to leverage prior knowledge and continuous improvement.
According to Pfizer’s Firelli Alonso, Senior Director, External Supply and Portfolio & Project Management, BioTherapeutics, one of the BPDG-report authors (and an Outsourced Pharma Advisory Board member):
“Examples of ‘platform methods’ are those we use at Pfizer – both for mAb drug substance manufacturing processes, as well as the corresponding analytical-method testing platform. Simply stated, we’ve had so many years of experience with a “typical” mAb manufacture – we consider this a “platform.”
“On the other hand, for us, a non-platform would be working with bispecifics or trispecifics. I assume this would be similar to other mAb manufacturers.
“Another example of a new platform method is the manufacture of AAV vectors for gene therapy using transient transfection vectors.. A non-platform approach might be using the baculovirus expression system.”
“This isn’t necessarily that we focus solely on what we know and are good at. But, for example and among other considerations, in the event of project surges or overcommitted FTEs, we consider programs with ‘platform methods’ as more readily subject to externalization and outsourcing.”
Which leads us back to the BPDG report and our analytical development services outsourcing tidbit mentioned above.
Outsourcing Can Wait
BioPhorum was established in 2008 as an “end-user community.” Today it includes “3,500 top leaders and subject matter experts” from some 90 manufacturers and suppliers.
The BPDG is a subgroup within BioPhorum of “global biopharmaceutical companies” including drug sponsors and CDMOs, and focused on CMC-related biopharmaceutical development, testing and manufacture.
Their new survey, “Trends In Outsourcing Of CMC Development Services For Biologics,” provides member feedback from “a mixture of large/established biopharma, small and medium biopharma and CDMO.”
This “self-survey” was aimed at understanding outsourcing approaches and governance, and focused on analytical development and testing as well as process development/manufacturing, project management and governance, and quality system and regulatory support.
The key takeaway for our purposes here:
Biopharma organizations employing “platform” strategies tend to keep analytical development activities internal until later in the development process, when they’ll then include them in their outsourcing strategies with CDMOs.
According to the BPDG survey, when it comes to analytical development and testing, more than 75% of respondents keep analytical development for platform methods in-house, and subsequently transfer to CDMOs to support process development.
Once the outsourcing of analytical development and testing is deemed desirable, more than 90% of respondents then co-locate analytical testing with process development at a CDMO to reduce complexity.
The report strongly suggests integrated CDMOs are favored over specialized contract testing laboratories (CTL) when it comes to providing these services.
According to the report, approximately 30% of respondents say they use a CTL for analytical method development over CDMOs.
The factors driving that co-locating of analytical services/testing with product/process development might be categorized for Outsourced Pharma readers as the “usual suspects.”
From the report:
“For most companies, the preferred approach appears to be co-locating development, analytics and manufacturing as much as possible.
“The key driver for this approach is to reduce the supplier network and minimize complexity (e.g. shipping coordination) and oversight (cGMP audits, maintenance).
“In many cases, this reduced complexity minimizes the number of technology transfers required to support the program’s execution and this way supports minimal timelines towards the clinic and market.
“Taking advantage of efficiencies between platform processes or analytics is attractive because it can reduce the internal resources required to move the program along. It gives companies the time and resources to carry more programs into early development than would be possible in a strictly internal structure.
“Where partnership with multiple manufacturing sites is desired, robust platform offerings also facilitate coordination, provide better control and ensure rapid scalability.
“Companies report a preference to co-locate analytical development, testing, process development and manufacturing whenever possible, as in a ‘one-stop shop’. Many of the reasons for pursuing this approach are based on a desire to reduce the internal resource commitment and capacity without sacrificing the quality of the technology package, the timeline or other programs within the pipeline.”
Interestingly, not mentioned in the report is our earlier-stated challenge drug developers tell us they face with capability and especially capacity challenges at CDMOs for comprehensive analytical-support and testing services for development projects.
I’d surmise contributing to this report’s findings of a reluctance to outsource analytical-support services earlier may in fact be this unstated factor.
The report concludes on this subject:
“As the number, novelty and diversity of biological therapies increase, the demand for external resources to develop and operate analytical methods and production processes with such capabilities will continue … added pressures of accelerated development and speed to market further require the Sponsor to have a sound sourcing strategy, execution and management approach.”
Now that’s a platform all readers have been working from for some time.