• July 12, 2023

At Olon USA, we value collaborating with our customers throughout the project life cycle. We understand each stage of your process is essential to produce successful results. Olon works diligently with its clients to produce both a positive experience and results that exceed expectations.

One of the services we excel in particularly well is our analytical services. Our analytical services can function in collaboration with other services or be offered as a stand-alone service. This service offering provides superior results and knowledge, but that is not all that is involved in making us impeccable within the analytical space.

You will be impressed with Olon’s Analytical Services

One of the many ways we stand apart is in terms of the support you receive from us. Our analytical program is extremely collaborative, allowing your team to remain involved throughout the entire process and continue to excel with the guidance and expertise necessary to meet your goals swiftly and successfully.

Here at Olon, we not only have the experience and expertise to aid in your vision, but we also have the equipment and technology to make it a reality. Clients that have visited our facilities consistently comment on the breadth and quality of the analytical instrumentation. We have found that staying up to date with the most effective analytical methods and tools is the best way to stay ahead of an ever-changing industry with increasing demands.

Olon has staff scientists of varying specialties, all contributing to the overall outcome of client projects. These professionals not only hold advanced skills and knowledge in all aspects of the space, but also coordinate with one another to maximize efficiency. We have the ability to examine your product, analyze it in our labs, and optimize the analytical support at each stage of the project.

Additionally, almost every process offered by Olon is performed in-house. We have UPLC/HPLC, IC, GC, GCMS, LC-MSMS, UPLC QTOF, FTIR, FT-NMR, ICP-MS, ICP-OES, Raman, KF, DSC, TGA, DVS, XRD and an extensive list of analytical procedures we can use to support drug substance and drug product programs.

Our Director of Analytical Chemistry, Mike O’Neill, is an expert in solid form screening. Because of this, we specialize in identifying the optimal salt and polymorphic forms for APIs. We’ve had countless programs where form optimization helped overcome difficulties with the inherent properties of the API. Our teams thrive on adversity, enabling clients to continue progressing their compounds along the drug development pathway. These specialized services and knowledge allow our clients to make solid filings with the regulatory agencies as they move into and through their clinical trials. The primary objective is to develop rugged methods and processes. We feel our in-house capabilities and areas of specialty bring this point home for our clientele.

When you’re filing an IND or NDA with the FDA, you are relying on the analytical data. These data are reviewed for approval within the chemistry manufacturing and control section of the filing. For this reason, analytical services must be a focus and priority to assemble a successful application. The quality and integrity of the data are integral to the success of the program.

Regardless of the nature of your analytical needs, we feel confident we can help. If you have a molecule that requires method development, we have an array of ways to make that happen. If you have a method started, we can bring it in-house and perform method optimization. We can deliver full method development and validation using a phase-appropriate approach (pre-clinical, clinical, or commercial) to support your needs.

We work with a wide range of small to mid-size pharmaceutical companies in various phases of operation. Some of these companies are entirely virtual. Others have limited lab capabilities or are developmental labs without GMP capabilities. We have been able to aid these companies by completing steps of the process that enable them to move through the trials necessary to bring their vision full circle. If you’re a small or mid-size start-up and identify with these pain points or others, we could be a great solution.

Analytical processes are vital to every program. We cannot afford to overlook the importance of having quality analytical data as development progresses. Other companies offer analytical services, but you’ll be hard-pressed to find another company that approaches analytical services from the collaborative standpoint that we do. Our first step is to assess the current stage and needs of the program and determine how we can navigate together toward the next milestones. The analytical package is a key deliverable at each stage in this industry, and we look forward to applying our skills to advance your program to the next level. Regardless of your needs, we can deliver the knowledge and value to support your program.