Benefits of Working with a North American CRO / CDMO

Recent years have exposed the vulnerabilities of global supply chains in the pharmaceutical industry. Disruptions overseas can cause delays, shortages, and even impact patient care. 

In response, a movement known as "onshoring" is gaining momentum. This trend involves pharmaceutical and biotech companies bringing manufacturing and production processes back to North America (or portions thereof), partnering with local Contract Research Organizations (CROs) or Contract Development and Manufacturing Organizations (CDMOs).

This shift towards North American CROs/CDMOs offers a multitude of benefits, fostering a more secure, efficient, and collaborative environment for drug development. 

We recently spoke with Dr. Rob Larsen, a distinguished member of the GL CHEMTEC Scientific Advisory Board, to learn more about the advantages of partnering with a North American CRO/CDMO.

Guaranteed Security of Supply

One of the primary benefits of partnering with a North American CRO/CDMO is the enhanced security of supply. By choosing a domestic or regional partner, pharmaceutical and biotech companies can avoid the disruptions often associated with international supply chains. 

“During COVID, we saw massive shipping and logistics issues, with key batches of products being lost or delayed. Working with a North American partner, particularly across the US and Canada, offers a level of confidence and reliability that’s difficult to match,” Dr. Larsen said.

This reliable, local source for important chemicals ensures a more stable and predictable production process, reducing the risk of delays or shortages that can impact product availability and patient care.

Access to Cutting-Edge Technology and Expertise

Leading North American CROs/CDMOs are at the forefront of innovation, investing heavily in state-of-the-art facilities and highly skilled personnel – all of which can provide huge advantages.
 
“There’s a misconception that working with a North American CRO/CDMO will potentially cost more. However, once you factor in the consistency, the security, and the access to advanced technology, the value becomes evident,” Dr. Larsen added. 

GL CHEMTEC’s facilities in Toronto, for example, allow us to deliver exceptional solutions to our clients, including:

• R&D Labs:  Dedicated to synthetic route development and optimization and adhering to ISO 9001:2015 standards.
• Kilo Labs: Our fully-equipped scale-up suites ensure safety, precision and efficiency during the process development phase.
• Pilot Plant: Offering a range of equipment and reactors to accommodate various reaction types and volumes.
• Class 6 Cleanroom: A controlled environment that upholds quality and minimizes contamination risks in accordance with ISO 13485:2016.
• Analytical Lab: Housing state-of-the-art analytical instrumentation, enabling comprehensive characterization and release of both small molecules and polymers.

This commitment to innovation provides our clients with access to advanced capabilities and expert knowledge, accelerating drug development and improving product quality.  

Seamless Communication and Collaboration

Real-time collaboration is a significant advantage when working with a North American CRO/CDMO. Sharing the same time zone enables prompt responses to inquiries and facilitates immediate problem-solving. “Just being in the same time zone brings so much relief. It eliminates the need for late-night calls and makes collaboration more fluid and effective,” Dr. Larsen said. 

This streamlined communication translates to faster decision-making, reduced project timelines, and ultimately, a more productive development process.

Streamlined Logistics for Faster Delivery

The proximity of North American CROs/CDMOs to their clients results in significant logistical benefits. 

Overnight shipping within North America is incredibly reliable," said Dr. Larsen. "You can track your shipments in real-time, and there’s a level of assurance that your materials will arrive when you need them."

Overnight shipping becomes a viable option, reducing both shipping costs and lead times. This swift delivery capability is particularly crucial for time-sensitive materials or when rapid adjustments to production are necessary. 

With a local CRO/CDMO, there's no waiting for overseas shipments that could be delayed by customs or unforeseen circumstances. Overnight delivery ensures a seamless flow of materials, allowing you to maintain an aggressive development timeline.

Robust Intellectual Property Protection

North America's strong intellectual property (IP) laws provide a vital shield for your innovations. Partnering with a North American CRO/CDMO means your novel compounds and processes are protected throughout the discovery, development, and manufacturing stages. 

Dr. Larsen emphasized the importance of IP protection during early-stage development: “When you're in the early discovery phase, controlling your molecules and process is critical. North America's high standards for IP protection ensure that your 'one shot on goal' remains secure.”

This robust legal framework discourages infringement, ensuring you retain exclusive rights to your intellectual property. This protection is critical, as it allows you to recoup the significant investments made in research and development, ultimately fueling further innovation in the pharmaceutical industry.

Convenient Site Visits

Working with a North American CRO/CDMO offers a significant advantage: easy access to your partner's facilities. This proximity goes beyond mere convenience; it fosters a collaborative and transparent environment that builds trust between partners.

By choosing a North American CRO/CDMO, you're not just selecting a service provider; you're gaining a partner whose facilities are readily accessible, allowing for a truly collaborative approach to your projects.

Imagine being able to:

• Take a short drive or flight and be at your CDMO's facility within hours
• Personally inspect equipment and labs, ensuring quality standards
• Attend project meetings in person, facilitating communication and problem-solving
• Conduct thorough reviews alongside your CRO/CDMO team

These on-site visits enable you to:

• Maintain rigorous quality standards through direct oversight
• Ensure alignment on project goals and timelines
• Strengthen your partnership through face-to-face interactions

This level of direct interaction leads to a more successful and productive drug development journey. 

Stringent Regulatory Compliance

North American CROs/CDMOs operate under the scrutiny of some of the world's most stringent regulatory bodies, such as the Food and Drug Administration (FDA) in the US and Health Canada. “We have a high level of IP protection in North America, and high standards to maintain that protection,” Dr. Larsen said, adding that this rigorous oversight provides a significant advantage for pharmaceutical companies. 

Meticulous quality control measures, for example, are implemented throughout the development and manufacturing process, ensuring that products meet the highest safety and efficacy standards. 

With a North American CRO/CDMO adhering to these strict regulations, you can navigate the path to regulatory approval with greater confidence, potentially bringing life-changing medications to market faster.

GLC: Your Trusted CRO/CDMO Partner

GL CHEMTEC is passionate about your success and committed to solving your most complex chemistry challenges. We offer fast, flexible, cutting-edge solutions to take your medicinal chemistry and early stage small molecule routes to the next level. Our commitment to a collaborative partnership means we scale and adapt precisely to meet your evolving needs.

GL CHEMTEC provides:

• A secure North American alternative to overseas providers, offering R&D labs, Kilo labs and scale-up facilities in the Greater Toronto area
• A local partner who will ensure secure shipping, real-time communication and the highest levels of IP protection for your early stage work
• A highly customer-centric culture with a 20+ track record of success
• ISO 9001:2015 and ISO 13485:2016 certifications
• A GMP Cleanroom with GMP Reactor Suites coming online soon