Choosing the right CDMO partner is one of the hardest steps a CEO must undertake when embarking on their drug development journey. The CEO must consider the quality, experience, and cost of a prospective partner, before signing-on to a relationship that should last years. But what happens when a CEO is forced to switch CDMO mid-partnership? In this article, the challenges and considerations of switching CDMO will be explored to provide guidance on what should be done when this daunting task arises.
Why would a switch be necessary?
There are a number of reasons why changing manufacturing partner might be necessary which include but are not limited to:
- CDMO knowledge gaps: Every drug candidate comes with its own unique set of challenges that a manufacturer and its client work together to overcome. In the case of live biotherapeutics, one-such challenge could be scaling a slow-to-grow bacterial strain up to commercial scale or maintaining appropriate cell viability post-lyophilisation. Sometimes, however, these challenges prove impossible for the chosen partner to solve. Perhaps due to a lack of expertise or experience. In such cases, it is necessary to change CDMO, to a partner who can provide solutions to the challenges.
- A breakdown in relationship: For an effective partnership, communication and healthy interactions are key to success. But when this communication breaks down it can lead to a company-CDMO relationship that proves difficult to manoeuvre. Once this communication breakdown begins to impact the output and productivity of the drug manufacturing process it might be time to re-assess the partnership.
- CDMO closure: Following a period of decreased investment into biotech and pharma sectors, companies’ drug development pipelines are often downsized or closed. This in turn can result in CDMOs having their contracted projects terminated or halted, which can lead them to wind-down their activity in a given drug-market or closedown completely.
- Candidate upscaling: As a drug program progresses along in development, a greater quantity of drug material is required. Sometimes the chosen manufacturing partner lacks the capacity to scale a program from a small batch into a larger one. In such cases, the expertise of an upscaling partner (another CDMO) is required.
- Technology upgrades: Drug development doesn’t always go to plan. For instance, a company might engage a CDMO to develop a liquid dosage form for their program and end up requiring an alternate dosage form (e.g a solid) which their partner doesn’t know how to produce. The reason for such technology changes could be to lower cost of goods, as some dosage forms are more cost-effective than others. As such a company would need to change partner.
How do I choose my new CDMO?
Once the need for switching has been identified, a new manufacturing partner must be selected. The selection process is a highly personal undertaking and will depend on the needs of the company. Generally speaking, however, the new partner should have the necessary expertise to manufacture the drug candidate at scale and to a high quality, in a timely manner, at a cost-effective price. Again, within the LBP market not all CDMOs share the same expertise e.g. in culturing certain strains or developing the necessary analytical techniques for regulatory purposes. Thus, it is vital that the company evaluates if the requirements of their candidate are compatible with the offering of the new manufacturer.
What is the process for switching CDMO?
Typically, the switch process will begin with a contract negotiation period, where the client and new CDMO outline expectations, timelines, and cost. This usually takes around 1-3 months.
Following the negotiation, materials must be transferred from the old CDMO to the new CDMO site. In addition to the physical material, knowledge between the old partner and new one must also be exchanged.
The extent of knowledge transfer will depend on the policies of the old manufacturer – for instance, a CDMO might have a proprietary process that cannot be used by the new one. In these cases, the new CDMO will work to develop alternative processes or techniques that don’t breach IP.
The overall timeline for onboarding and switching CDMO should take around 3-5 months in total, but this does depend on the circumstances of the prior relationship and the ease of knowledge transfer.
At Biose, we encourage newly onboarded clients to have an active presence onsite at our manufacturing and/or R&D facility. This facilitates accelerated process transfer, which enables our team to get to work faster!
It is important to note that the complexity of switching is directly proportional to the development stage of the drug candidate. This is because there is “more” to transfer over to the new CDMO at a later stage. More processes that must be transferred; more restrictions on the equipment that must be used; more instances for potential IP challenges. Additionally, switching sooner provides a perfect opportunity for optimising an existing process.
At Biose we have refined many processes transferred over from other CDMOs to increase yield, production time, and reduce cost!
When is the CDMO switch considered a success?
The new manufacturer will confirm that a drug candidate has successfully been transferred by completing a number of tests. There will be a comparison assessment to check if the yield, quality and viability of the new drug batches are the same as, or better, than the old CDMO’s results. The CDMO will also complete several analytical tests to obtain a Certificate of Analysis to verify the candidate complies with the client’s requirements.
Could Biose be the right CDMO partner for you?
Since it’s founding in 1951, Biose Industrie has prized itself on its expertise in bacterial manufacturing. As well as working with clients from the beginning of their R&D journeys, Biose Industrie has also successfully transferred over 20 drug candidates over from other CDMOs. As world-leading experts in LBPs and next-generation probiotics, there are no challenges the in-house team cannot overcome. With ongoing projects with world-leading microbiome therapeutic developers, ranging from preclinical candidates, all the way up to phase 3. Biose Industrie have the capacity, experience and know-how to bring your candidate to the market.
If you’re considering changing CDMO partner, feel free to contact me or my colleague Richard Ellis for a free consultation on: r.ellis@biose.com
About Biose Industrie
Biose Industrie is the world leading CDMO for microbiome therapeutics and Next Generation Probiotics. Our facilities comprise a center of excellence of 52 000m2 based in Aurillac, France and an applied tech transfer laboratory in Boston, USA. We are capable of taking your laboratory strain from process development and scale-up to the delivery of GMP manufacturing services of both drug substance and drug product at clinical and commercial levels. We also finalize the secondary packaging and labelling of your products for shipment to your clinical trial distributor anywhere in the world.