When it comes to cryogenic chemistry, the key to success is the skill, knowledge and experience of the scientific team—but that’s not all. Cryogenic chemistry is complicated. It requires specialized capabilities, specialized equipment, specialized handling—and thing go more smoothly when project managers who understand the delicacy of these projects are involved.
This article will focus on the value of having project managers experienced with cryogenic chemistry projects. This is especially important at Seqens CDMO, where we cover the range of cryogenic chemistry needs, from performing cryogenic chemistry in the lab in our 50-gallon vessel, or the 1,000-gallon vessel in our manufacturing plant. The large vessels can be used for batches ranging from 250 gallons to the full capacity of 1,000 gallons.
Cryogenic chemistry’s role in API manufacturing
As we’ve indicated in our analysis of the economics of cryogenic chemistry, temperatures of
–80o C are sufficiently cold for most cGMP manufacturing requirements. Working under such cold conditions remains both an art and a science. Cryogenic conditions are used to facilitate the following chemical transformations:
- Limit impurities.
- Process highly reactive compounds such as organolithium reagents.
- Improve reaction selectivity.
- Eliminate or reduce unwanted side reactions.
- Limit volatility of compounds for greater safety until conversion is completed.
- Prevent ice crystals from forming.
Because working with such cold conditions is tricky, there is a great deal of coordination required. That’s where the project manager’s skill and expertise come into play to help facilitate the project.
A slow, methodical process
Cryogenic chemistry is a slow, methodical process. Once begun, the reaction needs to keep moving to get it to the point where everything is stabilized. There is no stopping on weekends, which means getting operators lined up, getting weekend coverage, and making sure the Quality Control lab is available to check samples and provide quick data turnaround.
The project manager is a liaison for all these activities. While the chemical engineer assigned to the project oversees, trains, writes master batch records and is present during startup of the cryogenic phase of the project, the project manager coordinates the many aspects involved in keeping the project running smoothly.
Aside from keeping a finger on the pulse of the project and project team, and adhering to timelines, the project manager also keeps a careful watch on the finances. Cryogenic chemistry doesn’t always perform as smoothly as planned and changes in the chemistry will impact the budget. Additional time may be required to complete a step. More supplies may be needed.
Since we put great value on open and frequent communication, among the project manager’s most important role is to keep the sponsor aware of progress and of any changes to the plans, particularly if they could impact the budget so there are no surprises.
Seqens CDMO has a very high repeat customer rate and we attribute that to how well we manage our projects and live by our commitments. Successful project management is only possible with a strong committed team; a team that is working together to achieve the same goal—efficiently creating your API and delivering it on time.
Summary
As our series on how to choose a CMO suggests, it’s wise to seek out those firms who can reliably deliver the broad range of controlled temperatures that may be required to manufacture APIs for Phase I, Phase II, Phase III and clinical trials. This eliminates the cost or delays of technology transfer to other suppliers. In addition, it’s important to assess the project manager’s skills in keeping complicated cryogenic projects, with their potentially erratic scheduling, on track and on budget.
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