Leadership Perspective: Q: What is the benefit of a one-stop-shop contract manufacturing organization (CMO)?
With Keith Kentala, Vice President, Commercial Operations
Q: What is the benefit of a one-stop-shop contract manufacturing organization (CMO)?
A: The history of one-stop CMOs is interesting. From the early ‘80s, the “soup-to-nuts” CMO was preferred, as some large, capable pharmaceutical companies were getting involved in outsourcing to keep their assets at capacity as their own pipelines were dwindling. There became a split in opinion, however, as pure purchasing interests wanted a diversified supply chain – not having all its eggs in one basket – while on the development side, scientists liked working with a one-stop-shop because of the richness of the relationship developed. Click here to see Keith’s first article
It fell out of vogue for a while, as the CMO market grew and some providers were specializing in certain aspects – API development, or pre-clinical development, or certain dosage forms, for example.
But the one-stop-shop has become essential for some customers again. As global supply chains have become so complex and complicated to manage, it is increasing regulatory risk. In an effort to consolidate the supply chain, full-service CMOs are benefitting.
The “soup-to-nuts” CMO can take a customer’s compound from early development through to commercial manufacturing. No additional service provider is necessary. AbbVie Contract Manufacturing is full-service in this way, because, as a CMO embedded in a large pharmaceutical company, we have the equipment and expertise needed to cover the entire development-to-manufacturing pathway. For supply chain continuity, it is valuable to be able to offer early development to first phase clinical through to commercial.
It is worth noting that, because of our global facilities, we can diversify the supply chain within AbbVie, just by using our facilities in different geographic locations. Our clients who do this are not paying for tech transfer twice, since it’s all one relationship. There are lots of economies of scale when you diversify within one company by using multiple locations.
Despite being a one-stop-shop CMO, many of our clients do come to us closer to the phase 2 clinical cycle. We are honest with customers interested in a soup-to-nuts engagement if that is likely their best/most affordable option, as our scientific expertise and array of equipment can make earlier development a significant investment.
Even if a sponsor does not want a CMO for soup-to-nuts execution, they do want their CMO to offer comprehensive, all-inclusive services for the portion of project being outsourced. So if a client comes to a CMO at phase 2, or even later, they must be able to demonstrate an ability to handle it all: e.g., technology transfer, or changing a tablet to a capsule, range of packaging – whatever the need.
Whether going with one CMO for the full engagement, or using one for earlier development and transferring to another later in the pathway, sponsors are wise to expect certain cultural capabilities from their outsourcing partner:
- A CMO that owns regulatory filings (NDAs, CEPs, BPAs), or can demonstrate that it has experience getting a product to submission for other clients. This is your goal; make sure your CDMO has achieved this.
- A CMO that treats your product like its own. Do they understand the process from a client’s perspective? For example, will they charge you if a deadline is missed and aren’t using that service as scheduled? Or will they be flexible and work with you to accommodate misses and get back on track?
- A CMO that respects client preferences and needs. While no reputable CMO would risk its reputation to accommodate a client’s unworkable request, a good CMO will recognize there may be two ways to achieve one thing – and agree to pursue its client’s preference.
- A CMO that strives for excellence, knowing a patient is at the end of the commercial pathway. At AbbVie, excellent execution is expected – it’s a requirement. It’s in our cultural DNA, it’s what we do.