CMC Management

Focus on Your Core Expertise

Routine CMC is not rocket science. Routine CMC is manageable without decades of expertise.

As long as projects run smoothly. As long as activities follow the plan. In most projects neither happens. As soon as problems appear, expertise makes all the difference. Furthermore, CMC management without expertise will take an awful lot of your valuable time.
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Leave CMC to Us

Routine CMC is not rocket science. Routine CMC is manageable without decades of expertise. Why should Biopharmas invest in external expertise?

Well, one reason is Murphy´s law. Most projects don´t follow the plan, most projects don´t run smoothly. They tend to run along a bumpier road. And as soon as disaster strikes, expertise in CMC management makes all the difference.

But the main reason is time - your time. The time you would have to invest in proper CMC management. The time you would spend digging through dozens of CMC reports, looking for crucial mistakes. The time you need to figure out how to deal with the most recent problem. The time to assess CMC timelines and costs once again to report them at the next Board meeting.

Biopharmas have no time to waste on CMC. Biopharmas need to focus their time on their core topics and challenges - biology, pharmacology, and clinical testing. Those core topics leave precious little time for CMC management and this shows all too often.


End to End CMC Management

  • All CMC activities under our control.
  • All CMC CROs reporting to us.
  • All CMC activities neatly integrated in your project.
  • Focus on your core topics. Leave CMC to us.


Time is Value

Time is valuable, no doubt about that. But what is the impact of CMC on Biopharma´s time budget? At a closer look on the matter, we see three layers of CMC impact on time.

Most Biopharmas must operate with a limited headcount and most will have to do without a CMC expert on their internal payroll. But CMC requires at least some time - and this will have to be found somewhere. Usually in the schedule of a person with a different core expertise who could easily use all "CMC" time on activities that would add a lot more value but is forced to "waste" time on CMC. This is layer 1 - CMC cannibalizes the time of valuable resources.

While routine CMC management is possible without decades of expertise on the matter, expertise helps a lot in doing things fast and time efficient. Let´s have a look at an example. On arrival of a report, non-experts will usually go through the details of the entire thing, spotting issues here and there. After correction, the same process happens with version 2 and this cycle may be repeated several times. CMC experts on the other hand will just do a quick screen to assess the document´s general compliance with industry standards. Sub-standard reports will be returned immediately for correction without any deep dive into reported details. Those details, including time consuming cross references or calculations will be done only once, with a near final version. This is layer 2 - Biopharmas have to invest an disproportionate amount of time for CMC.

Lastly some light at the end of the tunnel - Biopharma´s time investment in CMC management frequently isn´t so large at all. Let´s be realistic - most Biopharma employees faced with the decision of either investing time in CMC or in topics within the personal expertise and responsibility will choose the latter. As a result, CMC will run with a minimum investment of time on the Biopharma´s side, relying on CMC CROs to manage without. Of course this is overly optimistic, mainly because the different CROs are not aligned. As soon as one of them gets out of step, others will follow soon, simply due to lack of information. This is layer 3 - CMC processes at Biopharmas run on time investment far below necessity.

And the light at the end of the tunnel frequently turns out to be a train at full speed.