What kind of relationship are you looking for? It’s the first question that should be on the minds of biotech companies once the decision to outsource clinical trial manufacturing of parenterals to a CMO has been made. Is it a transactional relationship? One where a service is sourced and swiftly delivered without much in the way of long-term planning or on-going work – perhaps most appropriate when a single drug is in the development pipeline. On the other hand, are you looking to build a long-term relationship with a partner that can not only deliver, but which is a good cultural fit for your organisation and can help you achieve your long-term objectives?
Depending on whether you are relationship- or transaction-oriented, will likely mean looking for very different qualities in a contract manufacturer. In a time when most companies are moving away from tactical approaches, in favour of being more strategic, I expect that most buyers of sterile fill finish contract manufacturing services would define themselves as being relationship-orientated, and see real value in investing time, energy and effort to achieve a productive outcome.
The way a biotech company contracts a CMO has a critical impact on the realisation of its goals, calling for a right-first-time approach to selection. With that being said, are we dealing with an art or a science? I would have to say both. Developing a true relationship calls for a mix of both head and heart in the final decision. Biotechs need to be thinking about two essential characteristics: the ability to satisfy the needs and requirements of the product, and the chemistry being right between the two organisations.
The first step, and arguably most important, is to evaluate the needs of your product and the key requirements. This will help clarify the qualities that the contract manufacturer must have, from which you can begin to assess each potential CMOs level of performance against each requirement. Requirements for most biotechs will cover:
- The range of services available
- Reputation and reliability
- Timelines and availability of manufacturing slots
- Capabilities, technology and equipment
- Quality and compliance history
- Scale of product versus facility capacity
- Geographic location
- Experience and expertise
Other factors that are important to be considered, include a CMOs commitment to regular communication and overall responsiveness, its approach to confidentiality and ability to be flexible and re-work schedules according to changing needs.
The second step is to ascertain whether you can foresee working with a contract manufacturer in a successful partnership. There is direct correlation between cultural alignment and the probability of a positive outcome, and so you should assess two qualities. Firstly, the sharing of a similar corporate attitude, philosophy and approach, this will ensure that values and work ethics align. Secondly, you can assess the quality of the relationships that are being built between individuals in both organisations from the very first meeting. It is about working with a partner who can best demonstrate a commitment to understanding your company’s experiences, needs, challenges and pressures.
Once a shortlist of contract manufacturers has been created, site visits can be considered. These will be invaluable in gaining insight into how each CMO operates by providing an opportunity to get to know the delivery team, check the functions of the site and gain first-hand confidence that the CMO can deliver on its promises.
So, when should a biotech start looking for a CMO partner? Late pre-clinical drug development is the most typical time, however, the sooner the better, especially if the biotech wants to evaluate and compare the services of a number of different CMOs before making a final decision. As a rule of thumb, 6-12 months in advance of the planned release of clinical supplies is the norm. However, another key consideration for selection may be to find a CMO that can counter any lack of lead time that a company faces and minimise its impact. Here, biotech companies are likely to find real competitive advantages in going with one company over another.
As with all relationships, honesty, open channels of communication and shared accountability will all factor in success. Putting in the effort early to ensure that expectations match and that both parties are clear on what they need to bring to the table, will reap the biggest rewards further down the line.