From Kilo Labs to Commercial Success: How CDMOs Bridge the Gap in Drug Development

Bringing a new drug to market is an immense undertaking fraught with challenges at every stage of the development process. One of the most formidable obstacles that pharmaceutical companies must navigate is the high-stakes transition from early-stage, small-scale research and development to Kilo lab/process development campaigns and commercial-scale manufacturing. These critical scale-up phases represent a significant hurdle that often derail promising drug candidates.

We recently spoke with Dr. Rob Larsen, a distinguished member of the Scientific Advisory Board, to explore some of the most common challenges in drug development and how leading pharma companies are leveraging strategic partnerships with CDMOs to overcome them. 

Why Most Drugs Fail: Challenges in Drug Development

As Dr. Rob Larsen pointed out in our discussion, only about 1 in 10 drug candidates succeed, highlighting the significant hurdles in bringing a new drug to market.

Failures can occur at various points for a multitude of reasons, including:

• Balancing safety and efficacy: Toxicity issues identified in early-stage studies can be a significant setback, potentially leading to the termination of a drug candidate's development. Efficacy must also be demonstrated to advance a drug candidate.
  
  “In early clinical studies, you are generally working with healthy volunteers and looking for safety, tolerability, and bioavailability data. You are not necessarily looking for efficacy in phase one. Once the candidate enters clinical trials, it should achieve the positive signals or biomarkers indicated, for the candidate to continue further in development.” Dr. Larsen said.
• Transitioning to larger equipment: Moving from R&D labs to kilo labs to fixed pilot or commercial-scale equipment is a critical transition where companies face significant challenges – both logistical and technical – in scaling up production.
  
  To overcome these challenges, Dr. Larsen recommends:
  • Extensive collaboration and coordination amongst the synthetic organic chemists, process engineers and pilot plant operators
  • Adjusting processes early on in order to ensure compatibility with the larger equipment
  • Conducting rigorous safety testing and validation procedures
• Process optimization and cost management: Balancing process optimization with cost considerations is another critical challenge. 
  
  “There are mainly two strategies to synthesis optimization in early development. Some organizations will do the minimum early on since the failure rate of candidates is high and the time and expense are not warranted. Others prefer to do a lot of optimization early to avoid impurity issues with process changes after toxicology studies,” Dr. Larsen explained, highlighting the challenge of balancing development stages with efficiency as the candidate progresses through development.

Why Leading Companies Leverage CDMOs to Succeed

To navigate the challenges of scaling up drug manufacturing, leading pharmaceutical companies are increasingly turning to strategic partnerships with contract development and manufacturing organizations (CDMOs). 

• Early collaboration for seamless transitions

  One of the key advantages of engaging a CDMO is the ability to collaborate with manufacturing experts from the earliest stages of development. This proactive approach helps anticipate and address potential scale-up issues before they arise.
  
  By fostering close coordination between R&D chemists, process chemists, engineers, and production staff, CDMOs can facilitate a seamless transition from small-scale synthetic routes to efficient Kilo scale chemistry (Tox batches) and ultimately to pilot plants and commercial manufacturing facilities.

• Flexibility and responsiveness

  For many drug developers, particularly biotechs, maintaining extensive in-house manufacturing capabilities can be impractical and cost-prohibitive. Partnering with a CDMO provides the agility to quickly adapt to evolving needs without the overhead of a large permanent staff.
  
  “It’s a real advantage having someone you can work with routinely, someone who can meet your needs quickly – it’s sort of like having your own development arm,” Dr. Larsen said, explaining that this flexibility ensures that critical production requirements are met efficiently, without the constraints of limited internal resources.

• Access to expertise and capacity without major capital investment

  Beyond manufacturing capacity, CDMOs offer a wealth of specialized expertise across the entire drug development lifecycle, employing a team of multi-disciplinary scientists. This can be invaluable, eliminating the need for substantial in-house capital investments, staffing and training.
  
  By leveraging a CDMO's knowledge, drug companies can focus on their core competencies while still ensuring access to cutting-edge manufacturing technologies and best practices.

• Long-term partnerships for quality and reliability

  One of the most significant advantages of partnering with a CDMO is the opportunity to establish a long-term, trusted relationship. By having an established partnership with a CDMO, pharmaceutical companies can:
  • Ensure consistent quality during the scale-up and process development phases
  • Apply quick decision-making and effective problem-solving during the course of their programs
  • Continuously optimize processes to enhance efficiency, quality, and regulatory compliance
  • Mitigate risks related to impurities or other potential issues

GLC: Your Trusted 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