Sterile & Non-Sterile cGMP Manufacturing
Xseer Pharmaceuticals operates a fully cGMP-compliant manufacturing infrastructure engineered to support the rigorous demands of both 503B clinical supply and CDMO commercial production. Equipped with state-of-the-art ISO-classified cleanrooms and advanced processing technology, we provide scalable, end-to-end manufacturing solutions for sterile parenteral products and complex non-sterile dosage forms. From small-scale clinical trial material (CTM) to high-volume commercial runs, every batch is executed with uncompromising precision and regulatory compliance.
Core Manufacturing Capabilities
- Sterile Aseptic Processing & Fill-Finish
Our core expertise lies in the aseptic manufacturing of sterile injectables. Utilizing ISO 5 (Class 100) primary engineering controls within ISO 7/8 cleanroom environments, we execute precision fill-finish operations for vials and syringes. Our sterile operations are governed by continuous viable and non-viable environmental monitoring, rigorous media fill validations, and strict endotoxin controls to maintain the highest standards of sterility assurance and patient safety. - Non-Sterile Production Suites
We feature dedicated, access-controlled manufacturing suites for non-sterile formulations, including oral liquids, topical formulations, and other specialized dosage forms. These environments utilize stringent cGMP air-handling and rigorous cleaning validations to strictly prevent cross-contamination and ensure batch-to-batch uniformity, stability, and therapeutic consistency. - Technology Transfer & Process Scale-Up
Transitioning a compound from the lab bench to the manufacturing floor is a critical vulnerability for any therapeutic program. Our technical operations team excels in seamless technology transfer, process optimization, and scale-up engineering—ensuring your pilot batches translate efficiently and reproducibly into commercial production without compromising quality attributes. - Integrated Quality Systems & Batch Release
Manufacturing is only as strong as its quality oversight. Every manufacturing operation is overseen by an independent Quality Unit and integrated with our in-house Quality Control (QC) laboratory. We provide comprehensive lot-specific Certificates of Analysis (CoAs), ensuring complete batch traceability, regulatory compliance, and confident product release.
Our Commitment to Partnership
This integrated manufacturing framework enables Xseer to support both FDA-regulated 503B production programs and commercial CDMO manufacturing projects with the same commitment to quality, traceability, and compliance.
