Outsourcing its drug manufacturing to a CDMO is very common for twenty years in France. Pharmaceutical companies, operating in a recessionary market, are outsourcing their production in order to improve their profitability and to reposition themselves on the innovation and commercialization of their medicines. There are hundreds of CDMOs in the world … So how to choose a quality partner in the long run?
For 15 years, I have been working with CDMOs from all over the world, from outside (as a supplier) or from the inside … what are the key points to choose your CDMO partner?
You are looking to outsource all or part of your medicines manufacturing, medical devices or cosmetics … the trusted partner you choose must first and foremost be a CDMO certified by the corresponding authorities.
Of course, depending on the type of product you want to outsource, as well as the region in which you market it, you have to validate that your potential partner has the required certifications (cGMP, FDA, ANVISA, ISO 13485, ISO 22716, etc …).
On this key criteria, you have to define what is the relationship you want to have with the CDMO? A partner of the same size as your company will allow you to have a balanced relationship in the negotiations. If you want to get closer to the “big guys” in the industry, you’ll get certainty about its long-term viability, but contract negotiations may be more unbalanced.
The contract manufacturers have developed their offer. We thus witness a transition from CMO to CDMO, the D bringing the dimension of development. Some of them propose to support their customers on the regulatory and marketing part while others have added product development services. The idea is to be able to offer global solutions to pharmaceutical companies. As part of a long-term partnership, you will be able to rely on the expertise of your CDMO, which can provide you with licensing-out solutions on side products to develop your brands.
Who says contract manufacturing or development also says it need of support whether regulatory, analytical, or simply quality. Expertise has shifted from pharmaceutical companies to CDMOs, and you may need the CDMO’s analytical ability for the future variations of your MAs, or when investigating their compliance, especially in the context of old AMM … this aspect must be taken into account when you choose! For that make you accompanied by a good sales rep.
The CDMOs have made different strategic choices in their developments. Some have specialized themselves in a technological niche (aerosols for example), or pharmaceutical forms (gels, or oral fluids …), some therapeutic areas and have become experts in their field … In general, they focus their expertise on a small number of production plants. Others, on the contrary, have made the choice to diversify themselves and are able to manufacture all pharmaceutical forms on many plants. Both strategies have their advantages … Everything will depend on the number and type of products you want to give them…
Depending on the type of contractor you want, back-up or full contract manufacturing of your product, you will have to choose a CDMO with one or more production plants … even if the risk management can be done differently than in duplicating the production tool, this remains an important criteria to take into account when making your choice.
Clearly on this criteria, I will be more decided. If you work with a contractor, it is to get closer to the market in which you market your medicine. Indeed, the contract manufacturers have real qualities of responsiveness, flexibility and proximity, very popular for the manufacture of local and old products. Nevertheless, this asset can be critical for the production of generics, whose economic equation can benefit from global markets.
Here we will speak in a more global way of capex … and even if these are more and more necessary and important on the manufacturing plants, with new regulations like serialization for example, the independent CDMO can be very responsive, even creative and manage to pull one out of the game. On the other hand, one of the advantages of the big Groups can be a centralization of the support services, bringing scale economies which brings us to the following point:
Is this the only reason you are working with a CDMO? Of course it is a criteria to take into account but pay attention to comparing what is comparable … I will quote for example Pharmaceutical companies production plants only integrating the direct workforce in the production costs of their product … and comparing the rates with those of a CDMO integrating itself the various support services in its tariff …
And from my point of view the most important … even if it is a subjective criteria, we remain human. Choose above all the CDMO which will give you confidence, through objective audits, certainly, but also through the people you meet who will make you want to entrust them with the manufacture of your medicines!