Formulation & Analytical Development

Xseer Pharmaceuticals provides phase-appropriate formulation and analytical development services designed to accelerate your therapeutic from the bench to clinical and commercial readiness. Operating within our fully cGMP-compliant laboratory infrastructure, our scientific team engineers stable, scalable formulations while simultaneously establishing robust analytical methods. Whether supporting a novel CDMO development program or supporting complex 503B compounded preparations, we mitigate risk early in the product lifecycle, ensuring your product is supported by the quality, purity, and stability data required for regulatory review.
 

Core Development Capabilities 

• Pre-Formulation & Dosage Form Design
  Successful manufacturing begins with a scientifically sound formulation. Our scientists conduct comprehensive pre-formulation studies—including solubility profiling, excipient compatibility, and degradation pathway analysis—to design stable, manufacturable, and scalable dosage forms for both sterile injectables and complex non-sterile therapeutics. 
• Analytical Method Development & Validation
  A formulation is only as viable as the analytical methods used to measure it. We develop, optimize, and validate robust, stability-indicating analytical methods tailored specifically to your API and dosage form. Our protocols strictly adhere to ICH guidelines, ensuring precise characterization of potency, purity, and related substances throughout the product lifecycle. 
• Comprehensive Stability & Degradation Studies
  Understanding the shelf-life and degradation profile of your product is a critical regulatory requirement. We execute ICH-compliant real-time, accelerated, and forced degradation stability programs within tightly controlled environmental chambers. This data is essential for establishing scientifically justified shelf-life specifications for commercial products and beyond-use dates (BUDs) for compounded preparations. 
• Integrated In-House Quality Testing
  By maintaining a fully equipped, in-house analytical and microbiological laboratory, we eliminate the delays and supply-chain vulnerabilities associated with third-party outsourcing. Supported by advanced rapid microbiological methods and comprehensive analytical instrumentation, our laboratory delivers actionable data with accelerated turnaround times. From rapid sterility and bacterial endotoxin testing to routine API assays, our integrated approach accelerates development timelines and provides real-time data to drive critical CMC and regulatory decisions. 

Our Commitment to Partnership 

This synchronized approach to formulation and analytical development allows Xseer to proactively identify and resolve technical challenges, streamlining the pathway to clinical trials and ensuring a smoother path to clinical readiness, commercial scalability, and ongoing regulatory compliance.