BWB 2023: Timelines, tech, trust critical to CDMO management success

Not respecting timelines and a reliance on proprietary technologies are among the warning signs a developer must be aware of when selecting a CDMO, says a biopharma consultant.

James Blackwell, president and principal consultant at The Windshire Group, spoke to a procurement-focused audience at Biotech Week Boston (BWB) today about the best practices when working with a contract development and manufacturing organization (CDMO).

The decision of “whether to make or buy” has long been discussed, and as most biotechs do not have the capacity on hand or the funds available to build, especially for a high-risk program, most look to these third-parties.

BWB kicked off today with a series of pre-event workshops

“The second biggest decision is whether you want one of those smaller, early-stage CDMOs that are focused on Phase I/II manufacturing, or whether you want an integrated CDMO that can do that and be the same partner all the way through to commercialization,” Blackwell said during a pre-event workshop today.

“This tends to come down to how much money is available as those top-tier companies will tend to be more expensive.”

But despite the size and the cost of a manufacturing partner, Blackwell told delegates several factors are critical when considering which CDMO to work with. This includes ensuring the CDMO has: a solid supply chain set up and the capacity to scale, a solid track record, experience with the desired type of modality and technologies around that, and a seriousness about operational excellence.

Beyond this, Blackwell highlighted some of the warning signs to look out for to avoid pitfalls when using a CDMO.

While a lack of responsiveness or transparency are major redlines, he warned disrespecting timelines and an insistence on inhouse technologies could also signal risk.

“People want to see the shortest timelines as possible, but you want to pressure test and make sure that’s a viable timeline for you. It goes back to the capacity they have and most CDMOs will be very upfront about that, telling you ‘we need this commitment by such a date to secure that capacity.’ You want to pay attention to what those terms are and what it costs you.”

He added it is vital that when a CDMO lays out its proposed way of handling the financials of securing that capacity and when payments are due, that they then stick to the manufacturing timelines on its end.

“Those timelines that they give you, you’ve got to make sure they are realistic, and they are not just saying something to get your attention to get you in on something they can’t deliver on. It’s not that people are unscrupulous, but some organizations may not be as transparent about what the reality is in terms of those timelines.”

Another red flag is a CDMO’s dependance on its own inhouse technology platforms, said Blackwell.

“You really have to watch out if CDMOs – some of very well known – want to use their own proprietary equipment. I’m not saying don’t do it, just be aware of what the implications are to you strategically.

“Their own proprietary technologies could lock you in,” he continued, adding this could leave a firm beholden to that CDMO throughout the whole product lifecycle. While some CDMOs will own the most suitable equipment and platforms relevant to developing a product, “always understand what your alternative scenarios are in that type of situation.”

Blackwell highlighted some other pitfalls to avoid, particularly with later-stage CDMOs: The need for the third-party to bring in a large number of partners (as this greatens the risk and could lead to additional delays and costs), a lack of the correct capabilities to move into commercial, and a failure of the CDMO in collecting enough information needed to file a successful Biologics License Application (BLA).