Chemistry, manufacturing and control for biological development

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There is no doubt that the process of marketing organic products is not easy. In addition to testing their safety and efficacy on an ever-increasing number of volunteers over a decade or more, biopharmaceutical companies must also design a protocol for scaling up and manufacturing the drug for regulatory approval and commercial use. Additionally, many biologics in development today address significant unmet needs, giving biofabricators a boost to accelerate their development times and get their biologics to market as quickly as possible while ensuring safety and the efficiency of their molecule. As a result, biofabricators are under tremendous pressure to rapidly develop streamlined chemistry, manufacturing and control (CMC) strategies.

But pharmaceutical companies don’t have to do this on their own. With the help of a contract development and manufacturing organization (CDMO), a company can optimize the CMC process, for efficient and reliable biological production and release.

A CMC strategy incorporates many elements that a biofabricator must plan to ensure a controlled and consistent product. These elements include reliable and efficient tests that characterize the chemical properties of their biologic, including its stability. A CMC strategy also includes descriptions of how and where the biologic is manufactured, including details of the process qualification, operation and maintenance plan. Finally, biofabricators should describe their plans for how to ensure the appropriate and consistent quality attributes of the biologic when the biologic is released and while it is stable. Ultimately, a CMC strategy has many steps and requires a dedicated effort to develop and execute it according to plan.

CMC’s design challenges for small biopharmas


Businesses need to understand the risks associated with CMC, and in this area, large pharmaceutical companies can benefit from their experience and industry knowledge. These companies have everything they need to test their molecules as well as to optimize and validate their manufacturing protocols. In contrast, small biopharmaceutical companies, such as virtual businesses, face additional challenges as they have fewer resources they need to design, optimize, and execute a CMC strategy. To make the process more efficient, many companies will recycle portions of pre-designed CMC plans.
for various products. Yet, they must always keep their end goal, regulatory approval, in mind from the start.

To maximize the chance of their molecule’s regulatory success in an accelerated timeline, companies must determine how their CMC strategy will work to meet FDA requirements as the program progresses. The FDA works with biofabricators to ensure that their CMC strategy is sufficiently defined, that the molecule and its target indication are fully understood, and that the formulation is optimized. However, biofabricators should allow more time to respond to FDA comments, as the agency may require extensive reviews. If the company struggles to align its strategy with FDA guidelines, it could ultimately impact product quality and reduce its chances of reaching market. The FDA could withdraw its marketing authorization, suspend production, and impose fines if the company ultimately cannot meet FDA expectations.

The factors that make a strong CMC strategy


To avoid complications with the FDA, biofabricators should consider more than one CMC strategy throughout product development and perform continuous improvement to optimize their approach. This will help them mitigate risk and satisfy regulators to provide much needed relief to patients.

Successful CMC strategies share many common elements. For example, a strong strategy includes robust testing, rigorous monitoring, and meticulous data collection. A successful manufacturer will monitor their development process to identify potential sources of risk. To reduce risk, the CMC plan should be phased and a scientific rationale should be provided for all major decisions made, from process development to product release and expiration date.

The complexity of CMC design may cause companies to take shortcuts
without a risk mitigation plan, but it can cause problems with their Biologics License Application (BLA) and lead to delays in regulatory approval. Instead, companies should start designing their CMC strategy as soon as a disease target is developed and should continue to refine it throughout the development process. Small companies must remain vigilant to avoid surprises at the end of the process that can slow down production and reduce the chances of their molecule reaching the market. Often, companies looking to avoid these problems and optimize the development of the CMC strategy will partner with a CDMO.

Call on a CDMO


As smaller biopharmaceutical companies play a larger role in early drug development, CDMOs are becoming a more integral part of the biopharmaceutical industry. CDMOs have experience working with biopharmaceutical companies and the FDA to bring biologics to market and can bring that experience to small businesses in need of advice. CDMOs understand how to develop risk-based, scientifically justified CMC strategies that the FDA can promote.

CDMOs also provide scientific, technical and regulatory knowledge. These companies can provide the scientific justification that biopharmaceutical companies need to establish their production, analysis and validation plans. Their advice will increase the chances of regulatory success without too much rework.

CDMOs can also reduce costs. Without cost controls, a small biopharmaceutical company will face financial challenges as development progresses. CDMOs can help small businesses understand the cost of each step of the CMC and the impact of their decisions on the budget, making it easier to reduce costs while increasing the chances of reaching market.

No pharmaceutical company should take CMC for granted, especially small companies that lack experience in the development of biological CMC. Even if a biologic succeeds in clinical trials, it will not succeed in the market without a strong CMC strategy. By partnering with a CDMO, biofabricators with limited experience bring their products to market faster to meet patient needs faster.

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