5 things to consider when choosing your drug product CDMO
There are practical elements of your decision: Do you need a vendor who can provide development on the formulation or process? Would your timelines favour in-house analytical capabilities? Do you need lyophilisation expertise or optimization? Does the geographic location of the drug product CDMO fit with your clinical trial strategy?
Whilst these are important points to consider there are also less tangible reasons you should apply to your choice, which are arguably as, if not more, as important than the practical reasons. In this article we address some of these and why they are important.
1. CULTURE
You wouldn’t choose a minder for your child without taking in to account if the person you are trusting is someone who’s morals and outlook on life align with yours, as well as checking what the day to day feel of the ‘day care’ looked like?
So make those same checks with your CDMO:
- Are they a good size fit with your company and your team? There is no ‘one size fits all’ approach when it comes to this decision. You’ll want to make sure that you and your business will make a difference to the CDMO, the same way that the drug product CDMO will make a difference to yours.
- Aim for Win / Win. Will there be an opportunity to achieve this utopian state where each of the parties involved gain from the collaboration and not just transactionally or financially?
- Culture. There are telling signs that can appear early in discussions that will give a clue as to what the culture is like at the CDMO. Are the CDMO team collaborative, positive and forthcoming with information? Do they want to make a difference? Are they empowered and do they feel like they have a voice? Do they want a strategic relationship and not just a signed proposal? The importance of a strong culture that aligns with your business is imperative because if things go wrong, it is culture and relationships that will enable a solid plan to pave the way forwards to success.
- Relationship. What is the approach of the CDMO to this? We know that long-term, strategic and tactical is best, but what are they like as people? Do they want to help you? Do they pick up on the small things (that can make the biggest difference)? Are they genuinely interested in helping you and are your two companies aligned? Early indicators of this can be as simple as how they approach your due diligence visit to site. Do they make suggestions and help your travel plans? Are they open with the agenda and willing to make accommodations and changes? A good partner would be keen to make things as easy as possible as early as possible.
3. CAPABILITY, WHICH TIES IS NICELY WITH EXPERIENCE
Whether your compound is highly potent, an antibody-drug conjugate (ADC) or a toxin, or if there is a compounding or filling step that is a little different (light or heat sensitivity, high viscosity, nitrogen overlay) or you require a lyophilization formulation to be developed or optimized; you need to be sure that the CDMO you choose is able to confidently work with your process to achieve the best possible results for you.
When speaking to your CDMO partner you should be reassured not only of their experience and expertise in fill finish but in the specific or niche area that you require. Always check for experience and that the team members have specific expertise, this will allow for conversations to be progressive and constructive from the start. With the right experience and knowledge, a CDMO will be able to bring added value to your project straight away.
4. QUALITY: REGULATORY AND ANNEX 1 COMPLIANCE
Within this heavily regulated industry it is critical to choose a partner who has a proven track record of cGMP compliance, has a strong audit history and a deep understanding of the latest regulatory updates and requirements. Check the size and experience within the Quality Department. Do they have the required skills and knowledge to fully support your project? If you’re heading to the commercial market, you will need a CDMO who has a quality team experienced in doing this. You don’t want to be left worrying about the details when making your submission.
Annex 1 compliance. The latest EU GMP Annex 1 revision (effective from August 2023) provided updated guidance on the manufacture of sterile drug products. It was published with new and specific guidance and contained a strong focus on risk management and having a contamination control strategy and cross contamination control strategy. If your current or chosen vendor is Annex 1 compliant they will have a deep understanding of the regulations and what is required.
Is the Proposal fully transparent? When you read it do you know exactly what is included in the scope and what services may be additional? Full transparency about out-sourced services will save the need for frustrating conversations at a later stage, as well as keep your budget on track for the project. Can the CDMO offer the services that you require in-house? Having the capability to offer the testing that your compound required is definitely a value-added service. Saving both the time and cost of contracting another outsourced partner.
The CDMO should also have a dedicated and experienced team of Project Managers. This team is at the heart of your project and should be best placed to coordinate between all the internal departments to feed you and your team with the information you require, regardless of the stage of the project. Meetings should be at a regular cadence and with additional meetings or communication when necessary.
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