Outsourcing IMP production – a modern twist on a classic tale…

Mike Parry

SCM Pharma

Finding a CMO to help you deliver your project needs can be a real challenge at the best of times. Mike Parry from sterile clinical manufacturing specialist, SCM Pharma, shares his words of wisdom about what considerations you need to take into account when looking for a CMO.

Having worked in the pharmaceutical manufacturing sector for many years, I have read a lot of literature about ‘how to choose a contract manufacturing organisation (CMO)’ and the various criteria a company developing a new drug product must take into consideration. Even though the pharmaceutical industry has completely changed over the last 20-30 years, especially with regards to outsourcing, many of the CMO considerations I read about today seem the same now as they were all those years ago.

Now, I’m not saying any of the information out there is incorrect, but it doesn’t seem to have evolved a great deal. My aim for this article is to therefore give you a new set of ‘hard and soft’ criteria to think about when looking to outsource production on your IMP. Don’t worry, like any good party, lots of the classics will be in the mix with a few modern numbers.

In today’s outsourcing market, many of the contract development &amp, manufacturing organisations (CDMOs) / CMOs offer clients a “cradle to grave” service package. Such CDMOs / CMOs range from smaller more specialist players to the seriously large organisations that ironically are getting to be as extensive as some of the big pharma companies that continue to streamline and outsource.

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“…it is worth looking for a CDMO / CMO that has the potential to scale-up…”

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The idea behind this all-encompassing approach is for CDMOs / CMOs to attract and secure new customers at an early stage. Why? Well, subject to a smooth product development process, successful licensing and retaining their allegiances into a commercial supply agreement, you have a partnership that can potentially last decades. So although you think you might be on the lookout for a tactical ‘supplier’ to help produce your small scale IMP, this, all going well, can very easily turn into a partnership for many years.

“Investigational” is, by its nature, a significantly higher risk venture for both parties since the attrition rate of investigational medicinal products (IMPs) is high. With this in mind, it is worth looking for a CDMO / CMO that has the potential to scale-up and meet ongoing supply through clinical trials and possibly at a commercial scale.

Cost is a very interesting area when it comes to clinical manufacturing. Unlike, commercial products where the CDMO / CMO must comply with licensed CMC criteria, IMP manufacturing processes and analytical techniques will need to be defined or refined. So while the ‘cost of goods’ is critical with commercial products it is of lesser significance with IMPs. Due to the high level of technical skill required in clinical trial manufacturing, it tends to be a fairly expensive process. However, by indicating the potential for longer term work, the CMO is likely to be much more willing to negotiate on costs.

Ultimately, it comes down to risk versus reward for both parties at this investigational stage. Certainly the IMP owners understand this and CDMOs / CMOs might expect higher rewards for their services when the long term future of a partnership is uncertain. But as already indicated, it makes sense for both parties to approach the onset of a relationship like the start of a longer term partnership.

In reality, the bog-standard list of how to select a CDMO / CMO mainly relates to commercial products but the same selection criteria cannot be equally applied to clinical products. Certainly the tick list of qualifying criteria e.g. regulatory compliance, quality standards, production capability, suitably scaled production capacity, product testing capability, experience, financial stability, training, project management etc remain true, but what about the ‘Order Winning Criteria’? What makes a particular CDMO/CMO a chosen partner?

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“Due to the high level of technical skill required in clinical trial manufacturing, it tends to be a fairly expensive process.”

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So, here is a list of 10 hard and soft selection criteria of what to look for if you’re in the market for a new CDMO / CMO partner to help with your IMP project:

Hard

1. When it comes to the practicalities of production, the old phrase “What will hold a lot, will hold a little” simply does not apply. IMP manufacturing facilities should be dedicated to the sole purpose of handling small scale batches. Cross contamination issues should be guarded against by the use of dedicated, isolated and / or disposable equipment thereby avoiding expensive and often inconclusive cleaning validation. Management, operators, planners, project managers and customer liaison staff involved with IMPs require a different ethos to those involved with commercial.

2. Dedicated QA &amp, QC including capability to both develop and validate analytical methods, since frequently IMP methods can be ill-defined.

3. Sufficient and experienced technical support for new product introduction, process development and actual productions.

4. Evidence of “frugal” use of materials as IMPs are frequently in scarce supply and massively valuable as API can also be on the pricey side.

5. Quality. Goes without saying almost, but this is a fundamental area (as it has always been and always will be) that you quite simply don’t want to take any chances.

Soft

6. Enthusiastic to work with, rather than for, customers.

7. Creative within the constraints of GMP. Manufacturing IMPs invariably demands designing and developing manufacturing processes often with very limited quantities of API. A CDMO / CMO needs to be able to recognise that process optimisation and validation may be a compromise but not, of course, at the cost of GMP.

8. It’s often the case with commercial products that confidentiality, the number one priority before discussions take place with potential CDMOs / CMOs, subsequently becomes the least discussed topic. IMPs however are potentially items of enormous value far beyond their material cost whose ultimate worth can be negatively influenced by a CDMOs / CMOs indiscretion or positively enhanced by virtue of a CDMOs / CMOs own intellectual property. Both contract givers and contract receivers need to understand such implications and ensure confidentiality undertakings truly reflect what each party ‘brings, or is likely to bring, to the show’.

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“My advice would be to use the hard criteria as a tick box exercise to distil down the potential CDMOs / CMOs.”

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9. Ease of doing business is often hugely underestimated. Despite our IT driven world, people still do business with people, and it is important to feel comfortable relating to the key individuals within a CDMO / CMO. Don’t forget it’s likely the relationship between the companies will last for many months or indeed many years.

10. Flexibility, which is vital when it comes to IMP production. Having a CDMO / CMO that is agile and can adapt to changes in the project can often make or break the whole thing.

In our own client research at SCM Pharma, we have found that quality and technical expertise remain the key hard drivers for selection of CMO partners for IMP projects with the relationship / ease of doing business and flexibility of increasing importance.

So you ask ‘Where does that leave me? How can I measure flexibility, enthusiasm etc?’

My advice would be to use the hard criteria as a tick box exercise to distil down the potential CDMOs / CMOs. But it’s the soft criteria you really need to consider carefully. Put aside your questionnaires and talk to a potential partner about how they do things, how projects are managed and above all meet all the folk responsible. Is this the kind of company I can see helping us get our project and product to market? If the answer is no, then move on.

So, in conclusion. Yes, there is a chance that choosing a CDMO / CMO for an IMP project might be more like a fling. However, there is also a chance that this CDMO / CMO might be the real deal for life. And like any great marriage, it’s about having solid foundations. You will no doubt irritate each other here and there, and need to compromise every so often. But in the long term, it’ll be well worth it.

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About the author:

Mike Parry is Business Development Manager at SCM Pharma. With over four decades of experience in pharmaceutical contract manufacturing, Mike has worked across all aspects of sterile and non-sterile production, including technology transfer, analytical method development, product formulation, production management and business development.

Having worked for an impressive array of companies that includes Bristol Myers Squibb, Speywood Laboratories, Weddel Pharmaceuticals, Wockhardt, Thornton and Ross, Medevale Pharmaservices and ViaPharm, Mike understands clients’ commercial and technical needs helping him provide comprehensive and competitive proposals.

Often one of the first points of contact for new customers at SCM Pharma, Mike is responsible for reviewing enquiries, assessing the CDMO’s ability to deliver against the project needs and guiding prospects through the enquiry process in order to provide a suitable and timely proposal to meet customer requirements.

What do you look for when choosing a CMO?