If you think Indiana Jones, Harrison Ford’s character in the classic cliffhanger Raiders of the Lost Ark had a rough journey, you have no idea what a molecule has to go through before becoming a drug.
“Indy’s” expedition tests his mettle again and again as he dodges a multitude of dangers and escapes enemies determined to destroy him in his search for the Lost Ark.
Indiana Jones had it relatively easy compared to a drug candidate’s journey.
Starting out as a molecule, it is probed, combined, shaken, processed, deluged with chemicals, intermediates, enzymes and whatever else scientists in a CDMO’s R&D lab decide to do before it emerges as a potential Active Pharmaceutical Ingredient (API).
It is then examined, analyzed, and, like our hero Indy, put through test after test to see if it can survive intact.
And that’s just the beginning.
From there it is brought to a kilo lab to see if it can be replicated without impurities sneaking in. If they do, the drug candidate is treated again to chemical baths and processes that remove then.
Once scale-up in the kilo lab is complete, the API candidate undergoes further duress under various conditions – heat, cold, humidity and such – and then shelved for a long, long time to see if it retains its power to treat the ailment it is intended to help remedy.
The molecule has another thing in common with Indiana Jones in addition to both taking a long, complicated and dangerous journey – crucial help from some friends.
This article will focus on collaboration among CDMOs that helps a molecule reach its destination – a pillbox in a patient’s medicine chest.
In a guest column published in Pharmaceutical Onlinerecently, author Rob Wright questions why he is unable to find any examples of collaboration between CMO/CDMOs. He wonders why it is not as prevalent as such “co-opetition” is between pharmaceutical companies, as when sponsors jointly develop new drugs.
We in the CDMO industry may not talk about it much, but collaboration is a way of life for us. In our quest to develop and manufacture high quality drug products faster and cheaper, we spend a great deal of time collaborating with other organizations, helping each other in order to get sponsors’ projects done.
Few if any of us try to do it all – each CDMO has its own specialization and expertise in what is a highly complicated business where experience with similar chemistry counts. Seqens North America’s expertise is in API development and manufacturing, for which we get many referrals from other CDMOs. Once the API is developed, if sponsors are looking for finished dosage forms, something we don’t do, we refer them to a CDMO with expertise in final dosage forms. We refer to CDMOs we know well. We know their reputations and expertise. We know their people. We know they would do a good job.
Referrals are not the only way we help sponsors move their projects along. When reference standards are needed, as they often are, we use our partner in India, mindful of keeping costs as low as possible. Their work is high quality and reasonably priced.
Likewise with testing: we deal with many different materials and have a very broad base of testing and analytical capabilities. But we don’t do everything. For specialized testing we collaborate with other CRO’s when needed.
We do our part of the project but we also help with the rest. We ask sponsors we work with what their other challenges are and how we might assist. If it isn’t something we can do in-house, we refer them to other CDMOs. Animal testing? We know an organization that does that.
As in Raiders, we CDMOs have friends when we need them. There isn’t a sponsor problem that we can’t help with directly or be able to point them in the right direction.
And it’s not just a matter of referrals when two CDMOs work together – there’s ongoing back and forth along the way. For example, if we ship to another company for dosage development, there’s a great deal of paperwork involved on both ends as we ship the material to them, and they come back to us for final shipping to the customer. It’s a true collaboration.
External collaboration is common among CDMOs. So is internal collaboration within a CDMO organization. With PCI Synthesis’ acquisition by Seqens, we have many additional resources at our disposal for seamless cooperation among Seqens units. We can now provide solid state chemistry or additional equipment or specific reactions without the cost and headaches technology transfer can create.
For example, if we need data on polymorphs or need to evaluate certain salts, we send to our French unit. They have the specialized equipment and expertise to provide us with the information we need to move our project to the next step.
We collaborate with and refer to companies only if we have a history with them and know they have a reputation for high quality work. It’s important to us to know their principals – and principles – and that they’ll do a good job.
Internally at Seqens we also consider best fit. If we have a customer on an aggressive timeline with a project that requires a lot of process and analytical development, it’s appropriately placed in the hands of Seqens North America. If on the other hand the customer is looking for a supplier for a large-volume commercial launch, the project is best handled by Seqens plants in France. If the product amount is moderate but there’s a concern about GMP, it fits well at our plant in Lahr which also has high pressure equipment. If the customer is focused on injectables, that’s what our Finland plant does. Each of our facilities has pots and pans, so to speak, but each is different. We can leverage those capabilities to the customer’s advantage.
Much like fictional movie hero Indiana Jones in Raiders of the Lost Ark, a molecule en route to becoming an API must make a long, complicated, dangerous journey before it reaches its destination. Guiding the molecule is a CDMO – but they sometimes, like “Indy,” need friends along the way in the form of collaborators who can use their expertise, equipment, or extra room to help the API achieve its goal.
If you’re interested in seeing how we can help, please call us at (978) 462-5555 or email us firstname.lastname@example.org.