As the number of therapeutic targets continues to ramp up both in terms of numbers and complexity, the race for a place to make the product becomes more intense. Companies are left with the age-old conundrum of whether to make or buy…… Meaning, make it in a facility of their own if available, or by space and time in a contract manufacturers facility.
Intuitively, companies often tend to want to run in their own facilities to make their own products, because it provides the possibility for more control. However, the simple economics of owning and operating a facility today is such that it often pays, at least financially, to hire someone else to do all this for you, even if it’s a premium over what you might spend on an in-house facility. For early phase companies that may have limited infrastructure, it may also provide a more efficient way to generate both clinical and commercial material instead of delaying submissions or product launches, because of the time and expense involved in establishing a new purpose-built in-house facility.
Economics and other timeline considerations aside, in selecting a suitable CMO for your situation, it is most important to assure that your product is manufactured to the appropriate quality and that your supply needs are always met. This is critical to avoid marketed products going into backlog as this would damage revenue flow.
Key among all other factors, is that you contract with a company that has a mutually compatible Quality Management System approach to the running of their business. Where possible, if you can arrange a collaboration with a company with a close QMS philosophy to your own company’s, or worst case, influence them to approximate to your own on key factors, then you’ll have far less problems and issues and the outcomes will be positive.
Some useful points to consider are:
1. Assure detailed quality agreements are established to maintain a clear set of expectations, responsibilities, specifications and deliverables.
2. Develop an effective mechanism for handling the inevitable deviation issues which will crop up.
3. Develop a working forum to interface with the CMO staff on key issues that might affect the manufacture of your product. Change management issues might be an example of this.
4. A resolution mechanism is also important. For example, if there is a deviation and the CAPA assigned to correct things is not agreed upon by all parties, then there needs to be another level of discussion at the executive level.
5. Common to all these situations is an agreed-upon policy for effective communication and transfer information between the client and the CMO. Without these mechanisms agreed upon prior to the start of the relationship, it can be expected that there will be difficulties and you as the customer may well be disappointed.
So, balancing this two-edged sword situation; balancing productivity and investment against the potential of landing yourself in a costly mess, is a major factor in determining whether you will have a successful outcome by employing a CMO.
The old saying “marry in haste repent at your leisure” is also appropriate /relevant here. Time taken upfront in the selection process and in establishing a personal relationship with key individuals will pay dividends in terms of trouble-free delivery of “your favorites product.”