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July 2024 | Blog

Choosing a Pharma Contract Manufacturing Partner: Ensuring Quality & Compliance


As innovators face more pressure to advance drug projects quickly and efficiently under compressed timelines, finding a contract development and manufacturing partner (CDMO) you can trust is more important than ever. However, the global CDMO market is increasingly complex to navigate. The market size is estimated to grow from $146.29 billion to $295.95 billion by 2033, with a CAGR of 7.3%. With numerous contract partners to choose from and high stakes, innovators must be informed to make the best CDMO partnership decision for their business.


The Importance of Quality & Compliance in a Pharma Contract Manufacturing Partner


Selecting the right CDMO is crucial for the success of your pharmaceutical program. Given the many, often specialized CDMOs in the market, innovators can refine their search and narrow their options to meet their drug program’s exact needs. There are dozens of characteristics to look for in a CDMO, including capabilities, focus area, location, cost, and scale, but perhaps most important is a CDMO’s adherence to quality and regulatory compliance.


No matter what therapeutic modality CDMOs produce, they must operate facilities that meet and exceed the stringent regulations and quality standards required to produce drug products for clinical and commercial use. Whether you are developing a sterile drug product—an injectable, solution, or ointment—an oral solid dosage (OSD) formulation, or a complex large molecule therapeutic, quality CDMO services are essential for your project to succeed.


Characteristics of a Quality-Driven Pharmaceutical Contract Manufacturing Organization


When evaluating contract manufacturing companies, you must ensure they have the necessary people, equipment, and company culture to maintain quality and compliance. Quality can be difficult to evaluate for first-time CDMO clients, but there are some telltale signs that a potential CDMO partner has strong regulatory and quality practices.


Strong Quality Management System (QMS)

CDMOs that consistently deliver on quality and regulatory compliance will have a robust QMS, as maintaining quality takes strong coordination across teams and facilities. An appropriate QMS will include comprehensive documentation for standard operating procedures (SOPs), risk management and risk mitigation systems, stringent employee training and competency tests, and plans for continuous improvement.


Robust Infrastructure

When you choose a CDMO partner, you may be entering a years-long relationship. As your company grows and your needs become more complex, you will want a CDMO with the infrastructure required to deliver consistent, quality batches at each stage of development. CDMOs with robust infrastructure will provide laboratory services coupled with small- and large-scale manufacturing to manage your program throughout the entire development journey.


Good Manufacturing Practice (GMP) Facilities

Manufacturing your therapeutic for clinical or commercial supply requires a CDMO partner with adequate production facilities. Maintaining GMP compliance is a must for your CDMO partner, and if your partner can provide GMP manufacturing at both small and large scales, it will help you scale your drug product throughout the development process.

Regulatory Track Record & Approvals

CDMO facilities are routinely inspected by regulatory bodies and their innovator clients. Make sure to reference your potential CDMO’s inspection track record, so look for inspection reports from leading regulatory bodies such as the FDA, DEA, EMA, ISO 9001, and others.


Excellent Client Communications

Keeping channels of communication open is fundamental to successful CDMO–innovator relationships, as it allows you to properly set and adjust goals, as well as mitigate problems if they arise. While your partner’s equipment and technical proficiency are important, it will be difficult to translate that into results for your drug program without strong client communications.


Reputation & Team

When a CDMO’s team has a wealth of experience bringing drugs to market, either as contract partners or innovators, they can better support advancing your product to the market. Quality CDMOs will have a leadership team well versed in drug development and regulatory standards and years, if not decades, of experience bringing drugs similar to yours to the market.


Common “Red Flags” for a Potential CDMO

Just as there are “green flags” or things to look for in a CDMO partner, there are also telltale signs of a checkered regulatory and compliance track record. Some “red flags” that should give your organization a reason to reconsider a pharma contract manufacturing partnership:


Lack of Transparency
An unclear understanding of capabilities, costs, and day-to-day operations can indicate an unorganized CDMO.


Compliance Issues

While every CDMO has a different story regarding regulatory compliance, you need to ensure that you will receive consistent batches of quality drug substances and drug products to further your drug development program. If a company has a history of rejected batches or regulatory violations, it may be a sign that problems with quality may continue.


Limited Experience
CDMOs without a wealth of experience working in drug development and manufacturing, including experience with drug products similar to yours, may be limited in their ability to foresee regulatory obstacles and overcome challenges in production.


TriRx Pharmaceutical Services: A Pharma Contract Manufacturing Partner You Can Trust


Selecting the right CDMO partner is essential to bringing your drug product to market, and understanding the keys to quality development and manufacturing is critical to making that decision.


TriRx Pharmaceutical Services is a CDMO headquartered in Norwalk, Connecticut, with an expanding network of development and manufacturing facilities worldwide and a dedication to customer success. TriRx excels at meeting and exceeding quality expectations with each batch and has the experience necessary to bring your product to market.


Get in touch with our team today to see how TriRx is transforming CDMO–innovator relationships with quality manufacturing services.