On the fast track to the clinic: early decisions in drug development

In the life science industry, the rise of more complex biologics like bispecific antibodies, fusion proteins and antibody-drug conjugate (ADC) therapies are placing new demands on development pipelines. Additionally, rapid development timelines moving from DNA to Investigational New Drug (IND) in under 15 months are becoming a new industry norm.

As a result, CDMOs working across different molecule types from preclinical to commercialization stages require manufacturing capabilities at different scales, as well as well-defined supply chains for all constituent building blocks. To help meet these demands, Lonza uses a variety of strategies and platform technologies to support its customers on the path from DNA to IND application.

Biologic therapies have been steadily on the rise for treating autoimmune disease, cancer, diabetes, and even neurodegenerative disease, due to increased demand for more targeted and precise medicines. Today, the biologics market comprises more complex molecular formats, including bispecific antibodies with two cellular targets, ADC cancer therapies which combine targeted antibodies with chemotherapy drugs, or fusion proteins that merge functional domains to enhance therapeutic activity.

To adapt to these developments, CMDOs require different strategies to keep abreast of market demands. Lonza, a Swiss-based global CDMO, combines effective strategies, state-of-the-art technologies and longstanding scientific expertise to tailor development solutions to a molecule’s needs early on.

Lonza’s strategic vision

“Lonza’s vision is to be the world leader in the CDMO space,” says Megan Mason, Global Implementation Manager at Lonza. “We aim to provide bespoke solutions for our customers, which range from very small companies to large industry players.”

“We never assume that ‘one size’ will fit all companies – even two small biotechs that seem similar may require very different approaches,” Harrison continues. “We tailor our work to the needs of each customer and their molecule, and where they are in their development journey.”

Having specialist teams with deep expertise in more complex biotherapeutic formats is essential to successfully tailor a DNA to IND path today.

“Lonza’s customers are all very different, as are the molecules they are working with,” explains Mason. “We see this particularly as the industry shifts towards more novel and complex molecular formats, such as bispecific antibodies”.

To better support this growing diversity and complexity, Lonza’s newly streamlined structure, part of its One Lonza strategy, draws on decades of expertise by consolidating its core strengths into three CDMO platforms: Integrated Biologics, Advanced Synthesis, and Specialized Modalities. These platforms leverage Lonza’s long-standing capabilities in mammalian, microbial and drug product services, hybrid chemistry and biology, and cutting-edge technologies like cell and gene therapies.

Reducing risk at the right time

Making the right decisions about a drug candidate early on can help set the foundation for its success down the line. By identifying a molecule’s potential liabilities, optimizing molecular properties, and aligning these with scalable manufacturing strategies, significant setbacks can be avoided, allowing an accelerated path to clinical and commercial viability. Failing to de-risk a molecule early can result in the need to change a cell line or redevelop the entire application process which can be costly.

Lonza focuses on identifying potential liabilities in the early phase of development, helping customers de-risk their programs by defining bespoke solutions during the planning stages.

“For example, recently, we identified a high risk deamidation site in the antigen binding site of a customer’s molecule during an early in-silico manufacturability assessment. This could have had a negative impact on the molecule’s function and potency. Fortunately, these are things that we can address in Lonza’s development program,” explains Harrison.

“Because the risk was associated with the antigen binding site, modifying the molecule’s amino acid sequence, which could intrinsically change the molecule’s biological properties and function, was not an option,” explains Harrison.

“To address this, we instead looked at the mitigation strategies across the process and tailored the purification strategy to eliminate the risk during this processing step,” says Harrison.

Applying the right tools for a strong foundation

Another way in which Lonza mitigates risk is by using a set of advanced early formulation assessments to evaluate molecule stability and compatibility. Lonza’s formulation experts draw on a well-equipped toolbox, deep experience and close conversations with the customer to identify which formulations are most likely to succeed for a given molecule.

These assessments are integrated with Lonza’s predictive modeling and high-throughput screening capabilities, enabling rapid data-driven decision-making. By combining scientific expertise with flexible, phase-appropriate strategies, Lonza helps ensure that promising candidates maintain stability and efficacy throughout development whilst accelerating time to clinic.

These approaches, when paired with Lonza’s GS Gene Expression System^®, a proven platform for scalable biologics production and a vast track record of products approved by global regulators since 2008, allow faster development decisions. The production system combines deep scientific expertise with a fully optimized mammalian expression platform, enabling efficient, high-yield production of even complex molecules.

 “We recently celebrated helping to bring over 100 molecules to market with our expression systems” Harrison emphasizes.

This milestone also underscores Lonza’s commitment to partnering with customers from early development through to commercial success. With each molecule brought to market, the platform continues to evolve; refining processes, deepening expertise, and reinforcing its role as a cornerstone of biologics manufacturing.

Accelerating from DNA to IND with confidence

For Lonza, accelerating the path to clinic is not just about speed – it’s about building a strategic CMC plan that supports regulatory readiness without compromising on quality. By integrating molecule-specific insights, technologies, and early risk mitigation tools, Lonza helps biotech companies move confidently from DNA to IND. Decades of experience underpin Lonza’s ability to accelerate IND timelines while maintaining the highest standards. With a 100% success rate in CMC module delivery and decades of biologics expertise, customers can trust that their programs won’t be delayed at the IND stage due to regulatory setbacks, giving them confidence from early development through to clinical entry.

Toxicology studies, often a bottleneck, can be supported by one of the industry’s fastest tox material supply offerings, enabling customers to initiate toxicology studies early, and giving companies up to three additional months to complete the toxicology studies and reduce filing delays.

Additional strategies like pool-based tox batches, early assay development, and parallel process development further accelerate progress.

“We can get tox material in as little as two and a half months if we’re using a pool, and we’ve already got a formulation that we can go into,” says Mason. “We can combine these approaches to figure out the fastest possible timeline that meets a customer’s requirements and needs.”

To support this, Lonza’s cGMP drug manufacturing facilities deliver high-quality material, delivering on time for key milestones and clinical trial readiness.

For novel formats, early CMC decisions are critical; Lonza’s integrated approach combines speed, quality, and strategic insight to accelerate IND with confidence.

Choose a partner for growth on the DNA to IND journey

“When it comes to early decisions on the road to IND, it’s important to get the right advice, but also to choose a partner that can grow with you,” says Harrison.

With over 35 years of experience and unique technology offerings, Lonza is already a valued partner of life science companies globally.

For a deeper dive, check out this podcast episode on “Navigating the biotech development journey from first steps to global scale with Lonza”: