• June 26, 2024

At Olon USA, we excel in providing comprehensive chemical development services designed to take your project from early phases to full commercial production. Our facilities and team, with over 38 years of experience, ensure that we can handle a wide range of chemical processes with precision and efficiency.

Scalable Solutions from Start to Finish

Our chemical development capabilities are tailored to meet the diverse needs of our clients. We specialize in scalable processes, starting with small-scale pre-clinical development to scaling up to commercial production. Our facilities are equipped to handle the demands of both early phase and commercial volumes, from 40 L to 2000 L, both GMP and non-GMP, and internal seamless transfer to our larger facilities within the Olon network if sizes grow beyond capacity.  This ensures that we can support your project at every stage. From early-phase development to full-scale commercial production, our team approaches each project with a mindset focused on scalability and efficiency.

Olon USA offers a robust suite of process development services including salt and polymorph screens, GLP characterizations, crystallization studies, route discovery, biocatalysis, PGI assessments, fate and purge studies, process safety, impurity characterization, DOE, process modeling and computational fluid dynamics, safety studies, and regulatory support, and much more, ensuring that we can meet the specific needs of your project. Our goal is to develop and optimize your chemical processes to ensure efficient, consistent, high-quality production. We leverage our extensive experience and advanced analytical capabilities to identify and control impurities, develop optimal process parameters, and ensure that your product meets all necessary quality standards.

Seamless Technology Transfer While Addressing Unique Challenges

One of our standout capabilities is our seamless technology transfer process. If a project requires scaling beyond our facility’s capacity, we can transfer the technology to other sites within our network at no additional cost. This ensures continuity and maintains the quality and integrity of your project as it scales up. Our network’s global reach and expertise mean that we can handle even the most complex chemical processes with ease.

Olon USA is uniquely positioned to address the specific challenges that arise in chemical development. Our extensive network of experts, combined with our experience in developing over 300 different APIs and holding 450+ DMFs, allows us to tackle even the most complex problems. Whether it’s navigating regulatory requirements or developing innovative solutions for complex chemical processes, our team has the knowledge and experience to deliver results.

Olon USA’s Competitive Advantage and Client-Centric Approach

In a competitive environment, Olon USA stands out due to our vast experience, comprehensive network, and the depth of our expertise. Our global network enables us to provide specialized services and leverage the strengths of multiple sites to deliver high-quality, efficient solutions. Our commitment to excellence and innovation sets us apart from other CDMOs in the industry.

At Olon USA, we understand that each client’s needs are unique. Our “large scale development mindset” and client-centric approach ensures that we tailor our services to meet your specific requirements. Whether you are a small biotech company or a large pharmaceutical corporation, we work closely with you to develop and implement the best strategies for your project. Our team’s heavy background in generics, expertise, and dedication to quality make us a trusted partner in chemical development.

Start a Conversation with Olon USA

Ready to take your project to the next level? Contact Olon USA to learn more about our comprehensive chemical development services and how we can help you achieve your goals. Our team is ready to provide the expertise and support you need to succeed. Let’s start a conversation about your project and explore how Olon USA can be your partner in innovation and excellence. Reach out to us today!