Quality impacts every facet of drug development, and it’s something all CDMOs attempt to achieve. Consequently, we were especially honored to be named an Overall Top Performer for Quality by the companies that have worked with us and named us as such in Life Science Leader’s CMO Leadership Awards. Although we won in each of the six major award categories, we believe Quality to be the most important.
Why? Just about every API we develop is heading to clinical trials for human use. These therapeutics might be used by our employees, their loved ones, our neighbors, our friends. We take that responsibility very seriously. So as the chemistry is being developed, from sourcing raw materials to the R&D lab and then to the manufacturing suite, we make sure that each process meets our very exacting specifications.
That attention to quality not only safeguards patients but helps sponsors who entrust their work to us successfully and more quickly attain regulatory approval. Making new molecules is a highly complex and difficult endeavor, all aimed at obtaining that regulatory approval. Use the wrong ingredient and the FDA or EMA will not accept the results. Make mistakes in the documentation and the FDA and EMA will reject. No proof of process validation? It’ll present a problem that takes precious time to address.
From our viewpoint, quality means having true process validation, reproducible analytical methods born of quality analysis in the first place, and good solid results. It’s not just a question of materials, but to us Quality implies all of the things that a CDMO does – process by process.
This article will focus on how Life Science Leader defines Quality and why they’re important for sponsors to consider when choosing a CDMO.
To determine award recipients, Life Science Leader magazine teamed up with Industry Standard Research (ISR). More than 120 contract manufacturers were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey.
The four criteria used to assess Quality were:
By the time we reach the point of executing the manufacturing process, the chemistry should behave as expected. That means documentation around the process is clean and devoid of extraneous reports. It means before going into manufacturing we’re fully prepared to make the product. It means we get the expected yield, in the quantity expected, and in the expected time.
Yield, meeting specifications and cycle time is how we measure right first-time quality. In order to achieve a high level of right first-time manufacturing, it’s imperative for a CDMO to prepare for that. It starts in the lab. We put a great deal of time and effort into process development and scale-up to assure that manufacturing processes will run smoothly. And before we jump into full manufacturing, we take an extra step. In the plant we do engineering batches to make sure risk is minimized.
As science progresses, the regulatory agencies respond. FDA and EMA regulations continue to change, to be refined, and to be redefined. As the agencies move CDMO rules closer to those for drug manufacturers, we too have to change. How? Every few years we reevaluate everything we do, from cleaning protocols and training to overall review of our quality systems.
Just to be sure we are fully compliant with all regulations, we also bring in independent experts to do gap analyses. Should a new rule warrant any change, we revamp those aspects of our quality systems that need updating, then train our staff accordingly.
We along with our customers set standards and specifications we want the project to meet. Of course, those specifications depend on the clinical phase for which the material is intended. But whether manufacturing early or late phase material, to achieve a high level of quality, we must constantly test those specifications. As a result, the analytical data undergoes reevaluation as the chemistry is developed.
As we’ve always stressed, a relentless focus on quality has to be paramount to all activities undertaken by CDMOs. At Seqens NA, that has paid off for our clients in timely delivery of quality material.
The ICH guidelines and FDA recommendations about how to effectively manage quality risk in drug manufacturing are clear and plentiful. But the truth is that the amount of qualification and validation that take place is really left to the discretion of drug manufacturers and their CDMOs. So why did Seqens NA win an award for quality? Contingency planning and risk management were big factors.
Long ago we implemented Quality Risk Management (QRM) as an essential element in every aspect of our drug product and substance development and manufacturing that extends throught the product’s entire life cycle—from pre-clinical to Phase I trials and through Phases II, III and commercialization.
We also adhere to Quality by Design (QbD) principles to ensure that all sources of variability affecting a process are identified, explained and managed appropriately. This enables the finished drug product to consistently meet its predefined characteristics from the start – so that it is “right first time.”
But that’s not all we do to manage risk. In our programs we have two teams working on projects simultaneously. If one succeeds and another fails, our sponsors still have their materials. And as we do with meeting quality performance metrics, we are perpetually managing for risk, daily deciding such things as the number of batches to make and developing contingency plans should a process be less than optimal.
It is all these extra steps—and our strong track record of regulatory approvals– that have contributed to receiving top honors for quality.