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    Quality Management in API Development For Drug Discovery Companies

    Quality Management in API Development For Drug Discovery Companies
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    As the pharmaceutical industry shifts toward increasingly complex drugs, quality management has become a critical differentiator in API development. If you lack the infrastructure and expertise to manage quality across the production journey, strategic partnerships with CDMOs become essential.

    Drawing on insights from pharmaceutical industry experts we've spoken with over the past year, here are five ways to build in quality from day one.

    Start GMP Thinking in R&D, Not at Scale-Up

    Quality problems at a commercial scale often trace back to decisions made in early development. One of the most common culprits is raw material selection.

    Last year, we spoke to Dr. Kasey Minick, a member of the GL CHEMTEC Scientific Advisory Board, and he had this to say: “If you get raw materials and you're buying the cheapest you can find, that's fine if you're only making a 10,000 liter batch. But let's say you want to make 600,000 liters of it. All those impurities in that cheap raw material are going to limit your manufacturability. They're going to clog your filters in sterile filtration processes.”

    These aren't hypothetical risks. Impurity-related failures can lead to:

    • Clogged filters in sterile filtration processes
    • Unplanned tank cleanings and line changeovers
    • Batch failures that derail timelines and budgets

    The solution is to incorporate GMP thinking from the earliest stages, not as an afterthought before scale-up. This means selecting raw materials with commercial-scale purity requirements in mind and designing processes that will hold up when volumes increase.

    Working with a CDMO that offers an integrated pathway from R&D through scale-up can help. GL CHEMTEC, for example, moves projects from R&D labs through Kilo Labs and Pilot Plant to GMP Cleanroom, ensuring that processes developed in early stages are already designed with manufacturability in mind.

    Partner With a CDMO That Owns the Full Process

    Leading biotech companies are now increasingly partnering with CDMOs that can:

    • Manufacture their API

    • Test and characterize it in-house with GMP or GXP analytical capabilities

    • Release it with the Certificate of Analysis they need

    process


    And the reasons are clear: Fragmented partnerships can create fragmented quality. When manufacturing happens at one site, testing at another, and release somewhere else, handoff risk multiplies and accountability gets murky.

    In our article on Nearshoring, Green Chemistry, and the Power of CDMOs, Dr. Minick highlighted the importance of consolidating capabilities, urging companies to "evaluate all of (a partner's) capabilities because you want to utilize as much of those in one place."

    This kind of consolidation keeps accountability clear and reduces the handoff risk that often derails timelines. Keep in mind that certifications definitely matter. ISO 9001:2015, ISO 13485:2016, and GMP compliance should be baseline requirements when evaluating any partner.

    Contact us to learn how our GMP capabilities can accelerate your development timeline. 


    Get Tech Transfers Right

    Tech transfer is one of the most common points of failure in API outsourcing. Biotech companies often underestimate how much documentation and context is required for a CDMO to replicate their process.

    In our article on Choosing the Right CDMO, Dr. Scott L. Dax, a pharmaceutical consultant with decades of experience managing CDMO partnerships, put it this way: “Biotech companies often need some coaching on what to expect and what to provide in order to make tech transfer efficient.”

    A strong transfer package should include:

    • Detailed experimental procedures for each step
    • Data and troubleshooting notes from past iterations
    • Insight into what has and hasn't worked
    • Clear specifications and acceptance criteria

    Without that level of transparency, your CDMO may be forced to make assumptions that lead to rework, delays, and increased costs. To avoid issues, ask prospective partners to spell out their tech transfer requirements early. A good CDMO will tell you exactly what they need. If they're not asking questions upfront, that's a red flag.

    Set Specifications Early

    Drug substance and drug product specifications are your responsibility as the biotech client. These define the acceptable ranges for purity, impurities, potency, and physical characteristics that your API must meet.

    The challenge is that setting appropriate specifications requires deep expertise in analytical chemistry, regulatory expectations, and manufacturing realities. Many companies, especially emerging biotechs, don't have that expertise in-house.

    Dr. Dax was direct about what's at stake: “If you don't have the right expertise in-house, it can lead to making an API that's not suitable for human dosing.”

    This is where the right CDMO partner makes a difference. Look for one that will actively guide you through setting specifications, not just execute what you hand them. The key is engaging that expertise early, before specifications are locked in.

    Break Down Silos with Multifunctional Teams

    Quality suffers when functions operate in isolation. Formulation, analytical, manufacturing, QA, and regulatory teams and consultants all bring different expertise, and problems slip through when they're not talking to each other. The right CDMO (with the right collaborative approach and culture) can help. 

    “When you've got a CDMO that brings everyone into the loop and you start having multifaceted project meetings, then you've got products that are made very well and that stay on the market for decades,” Dr. Minick said, emphasizing the value of varied expertise. “It's a real game-changer to have a CDMO that has expertise in formulations, understands regulatory affairs, and can collaborate closely with manufacturing.”

    On your side, a CMC (Chemistry, Manufacturing, and Controls) lead who follows the product from conception through its lifecycle can serve as the connective tissue across these groups. But structure alone isn't enough. People also need to feel comfortable flagging problems early.

    In our article on Building Successful CRO/CDMO Partnerships, Dr. Dale Cameron, a pharmaceutical industry consultant with decades of experience managing CDMO partnerships, emphasized this point: “If employees don't feel comfortable speaking up in front of leadership, they're unlikely to document negative results. That means crucial information stays trapped in someone's head rather than being shared with the team.”

    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.