Process Development

Ensuring Scalability
Process Development Services
Ensuring Consistency from Early-Stage to Market Launch
At BioSpring, we specialize in creating robust, scalable, and efficient processes that accelerate the transition of your nucleic acid therapy from the clinic to the commercial market. With over 140 successful process development projects each year, we are a trusted partner to hundreds of pharmaceutical and biotechnology companies worldwide, ensuring that every stage of your development journey is optimized for success.
Our team of experienced chemists work closely with you to establish an effective, reproducible, and scalable manufacturing process
Comprehensive Process Development Services
- Risk Evaluation and Optimization: Before moving into clinical and commercial production, we thoroughly evaluate risks and opportunities for optimization in the manufacturing process. This ensures that potential challenges are addressed early and that your production process is fully optimized for cost, efficiency, and compliance.
- Mid-Scale Production Capabilities: Our mid-scale production department specializes in manufacturing volumes from hundreds of milligrams to 50 grams. This flexibility allows us to scale as your project grows, ensuring smooth transitions and consistent output.
- Cross-Department Integration for Seamless Scale-Up: Successful process development requires flawless coordination between departments. At BioSpring, we emphasize cross-department integration, ensuring a seamless scale-up from lab-scale to full-scale cGMP production. This collaborative approach helps us address potential challenges early on, ensuring that your therapy reaches the market with maximum efficiency.
- Expertise with Complex Molecules and Modifications: We bring extensive experience with complex molecules and modifications, allowing us to develop and refine processes for even the most challenging nucleic acids. Whether there are custom modifications or special conjugation chemistries, our team excels eat establishing effective processes to manufacture and analyze more complex constructs.
- Maximizing Purity and Yield: Our focus on process optimization ensures that every manufacturing process is designed to maximize both purity and yield and at the same time maintain the highest levels of product quality while minimizing waste and expense. For standard molecules we use streamlined platform processes that are both efficient and cost-effective.
- Technologically Leading R&D: Innovation is at the core of everything we do at BioSpring. Our R&D team is technologically-leading, continuously developing new process technologies that push the boundaries of nucleic acid manufacturing. This commitment to innovation enables us to stay ahead of industry trends and offer our clients cutting-edge solutions.
Proven Track Record
With over 140 successful process development projects annually, we have the experience and expertise needed to support your therapy from early research through commercial launch.
End-to-End Support
Our cross-department integration ensures seamless process development and scale-up, minimizing risks and ensuring smooth, reproducible results.
Scalability
From mid-scale production of hundreds of milligrams to 50 grams, we ensure a smooth and scalable transition as your project readies for cGMP batch manufacturing.
Specialized Expertise
Our team of tenured nucleic acid chemists will share their knowledge and expertise to prepare your program for clinical and commercial readiness.
Partner With BioSpring
At BioSpring, our mission is to support your nucleic acid therapy at every stage. With our proven expertise, technological leadership, and commitment to quality, we ensure your manufacturing process is optimized for purity, yield, and scalability.
Learn more about our process development services and mid-scale production.
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