Analytical Method Development Services

For over 30 years BA Sciences has been developing GMP-compliant analytical test methods for use in drug product characterization.  These methods include assay, related substances, dissolution, identification, elemental impurities, and content uniformity. We have up-to-date instrumentation from multiple manufacturers (Water, Agilent, etc.), with redundancy, to handle all method forms.

At BA Sciences, analytical development projects can be custom-designed to meet your specific analytical requirements, regardless of what phase of development your drug product is in. Our pharmaceutical method development capabilities include HPLC, UPLC, ICP-MS, GC, dissolution, particle size, ion chromatography, and mass spectrometry.

Analytical Development Services

  • Method Development for Small Molecules, Large Molecules, Biologics, Solids, Liquids, Patches, Gels, Ointments, Parenterals, Ophthalmics, and Inhaled Products
  • Method Development of Drug Substances, Drug Products, Excipients, and Raw Materials
  • Multiple Chromatography Techniques, including HPLC, UPLC, GC, LC-MS, GC-MS, and Ion Chromatography
  • Method Optimization

How Our Work Benefits Pharmaceutical Companies

The analytical method development services we provide for our clients is a critical step in the drug development process. It is important that proper methods are developed and validated to ensure drug products meet all regulatory requirements and industry standards for accuracy, reliability, and reproducibility. All of these criteria must meet current Good Manufacturing Practices for the pharmaceutical market.

Among the many qualities that must be tested with these methods are identifying and quantifying ingredients, testing the potency of the particular active pharmaceutical ingredient, and checking for any impurities that may exist. Given the complexity and necessity of these, it is imperative that analytical method development and validation services are accurate, compliant, and provided quickly enough to enable a drug development company to get their drug into clinical trials and eventually to market.

Why Choose BA Sciences?

We have served the life science industry for more than 30 years, providing high-quality analytical testing from our cGMP compliant, FDA and DEA registered, and ISO/IEC-17025:2005 certified laboratory just outside Boston. Our clients have come to depend on us because we are devoted to providing the highest levels of service in everything we do. We differentiate ourselves by giving each customer a dedicated project manager to help develop the strategies and identify the services that best fit its needs.

When it comes to our analytical method development services or anything else we do, our clients can count on receiving results-driven capabilities and innovative processes to solve their problems. When we create methods for customers, they will be delivered in an easy-to-understand format that takes them step by step through the procedure. These are paired with detailed reporting that gives them all the information they need with clarity and precision.

In addition to our analytical method development service, we are adept at providing specialty services that include on-site environmental monitoring and inductively coupled plasma — mass spectrometry analysis. We also are the only analytical development laboratory in the area that is equipped for a wide range of other specialized analytical and microbiology testing services.

Our commitment to being on the leading edge of technology is a major component of our success. For example, we have implemented LabWare LIMS™, LabWare ELN™, and an environmental monitoring software solution to provide our customers with the fastest and most accurate results. We also invest in updated equipment and other technology on a regular basis. To learn more about everything we have to offer, get in touch today.

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