Strategy how to Shorten Time-to-Market for Biologics

Time-to-market (TTM) refers to the period required to bring a new biopharmaceutical product from its initial concept phase to commercial availability. In the biologics industry, TTM is a critical metric, as it directly impacts competitiveness, return on investment, and, most importantly, patient access to life-saving therapies. The process encompasses early-stage development, preclinical and clinical trials, regulatory engagement, manufacturing scale-up, and market approval.

Reducing TTM in the biologics sector requires a strategic and multifaceted approach. Companies must address bottlenecks, optimize development workflows, and integrate advanced technologies while maintaining compliance with global regulatory standards. Partnering with an experienced biologics CDMO can significantly streamline this process, ensuring an accelerated yet compliant path to commercialization.

Integrated Development and Manufacturing Approach

A well-coordinated transition from early-stage development to full-scale manufacturing is crucial for reducing TTM. Biologics CDMOs that offer integrated services can help streamline this transition by aligning process development, analytical methods, and regulatory requirements from the outset.

Cross-functional collaboration among scientists, engineers, and regulatory experts ensures that manufacturing scalability is considered from the earliest stages. Platform upstream processing solutions and flexible manufacturing setups enable faster adaptation to process changes, reducing unnecessary delays and enhancing overall efficiency. According to industry data, companies that implement an integrated development model can shorten TTM by up to 30% compared to traditional linear approaches.

Regulatory Engagement from the Start

Regulatory engagement at an early stage is essential to minimizing delays associated with approvals and compliance requirements. Regulatory agencies such as the FDA and EMA offer structured guidance through Pre-IND meetings, Scientific Advice Meetings, and Fast Track designations, all of which can provide valuable insights into expectations for clinical trial design, safety requirements, and manufacturing standards [1].

By seeking regulatory input early, companies can proactively address potential compliance risks and optimize their development strategy. Engaging with a biologics CDMO that has extensive experience navigating regulatory pathways ensures that documentation, validation processes, and clinical trial strategies align with agency expectations, mitigating potential roadblocks [2]. Studies show that early regulatory interaction can reduce approval timelines by 6 to 12 months and increase the likelihood of first-cycle approvals by 50%.

Optimized Platform Upstream Processing and Downstream Development

Utilizing standardized platform upstream processing methods is a proven way to reduce development timelines. These platforms include scalable cell culture systems, high-yield expression technologies, and single-use bioreactors that minimize setup time and enable rapid scale-up. Process intensification strategies such as perfusion culture further enhance productivity, leading to shorter batch cycles and increased manufacturing efficiency.

For example, adopting a perfusion-based upstream process can increase productivity by 3-5 times compared to traditional fed-batch methods, significantly improving TTM for biologics [3].

Downstream development is equally critical in achieving an efficient and reproducible purification process. Advanced chromatography techniques, high-capacity resins, and automated filtration systems enhance product recovery while maintaining strict quality standards [4, 5]. By integrating real-time analytical methods and process control strategies, companies can improve batch consistency and optimize yield, reducing manufacturing variability and accelerating product release. Studies indicate that implementing high-throughput downstream processing can cut purification time by 40%, directly contributing to reduced overall TTM.

Efficient Tech Transfer for Faster Scale-Up

Tech transfer is a crucial yet often challenging phase in biologics development. Efficiently transferring processes from laboratory-scale development to full-scale commercial production requires structured methodologies, comprehensive documentation, and real-time collaboration between teams [6]. A well-executed tech transfer strategy can significantly reduce TTM by minimizing the risk of process deviations and ensuring seamless implementation at scale.

To achieve fast and high-quality tech transfer, organizations must employ risk-based assessment frameworks, standardized data documentation, and digital collaboration tools. Conducting pilot-scale runs before full-scale manufacturing helps validate process parameters and mitigate potential challenges before commercial launch [7].

Reports suggest that companies leveraging advanced tech transfer strategies experience up to 30% faster commercialization timelines. By leveraging the expertise of a biologics CDMO with established tech transfer capabilities, companies can streamline knowledge transfer, enhance process robustness, and accelerate manufacturing readiness, reducing TTM by as much as 6-12 months.

Conclusion

Reducing time-to-market in biologics development requires a combination of strategic planning, regulatory foresight, advanced platform for upstream processing, robust downstream development, and efficient tech transfer methodologies. Especially end-to-end Biologics CDMOs play a crucial role in accelerating commercialization by offering integrated solutions that optimize development timelines while ensuring compliance and quality.

By adopting these best practices, companies can navigate the complexities of biologics development more effectively, bringing innovative therapies to patients faster and maintaining a competitive edge in the rapidly evolving biopharmaceutical landscape.

References

1. European Medicines Agency, Scientific advice and protocol assistance, 2025.
2. Wong AK, Mooghali M, Ramachandran R, Ross JS, Wallach JD. Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics. JAMA Netw Open. 2023; 6(8) :e2331753.
3. Ou J, Tang Y, Xu J, Tucci J, Borys MC, Khetan A. Recent advances in upstream process development for production of recombinant adeno-associated virus. Biotechnol Bioeng. 2024; 121(1): 53-70.
4. Matte A. Recent Advances and Future Directions in Downstream Processing of Therapeutic Antibodies. Int J Mol Sci. 2022; 23(15): 8663.
5. Wachter S, Angevin T, Bubna N, Tan A, Cichy A, Brown D, Wolfe LS, Sappington R, Lilla E, Berry L, Grismer D, Orth C, Blanusa M, Mostafa S, Kaufmann H, Felderer K. Application of platform process development approaches to the manufacturing of Mabcalin™ bispecifics. J Biotechnol. 2023; 377: 13-22.
6. Chahar DS, Ravindran S, Pisal SS. Monoclonal antibody purification and its progression to commercial scale. Biologicals. 2020; 63: 1-13.
7. Kaczanowski R. Strategies for Overcoming Common Challenges in Tech Transfer. Pharmaceutical Technology, 2024; 48(11): 31-33.