About HC Biologics
HC Biologics, Inc. — a Division of HC Smart, Inc. exists to give clinics and research laboratories a supply partner whose documentation stands up to scrutiny. From raw material qualification to the final release check, every step is written down, reviewed, and retained.
01
Every active pharmaceutical ingredient we use originates from a facility registered with the U.S. Food and Drug Administration. Suppliers are qualified before onboarding and re-evaluated on a fixed schedule, and each incoming shipment arrives with documentation that ties it back to its manufacturing batch.
02
Compounding, filling, and lyophilization take place in classified cleanroom suites with continuous environmental monitoring. Gowning, material transfer, and line clearance follow written procedures, and personnel are qualified through routine aseptic technique assessments.
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Our quality unit reviews each batch record before release. In-process checks cover appearance, fill weight, closure integrity, and reconstitution behaviour, and retained samples from every lot are held under controlled storage for future reference.
04
Independent analytical laboratories verify identity by mass spectrometry and purity by HPLC, with additional testing for endotoxin and sterility where the presentation requires it. The resulting certificate of analysis travels with the lot and is available to account holders on request.
All materials supplied by HC Biologics, Inc. are intended for laboratory research and in-vitro investigation by qualified professionals. They are not drugs, foods, or cosmetics, have not been approved by the FDA for any therapeutic use and are not intended to diagnose, treat, cure or prevent any medical disease or condition. Any and all content provided on this website is strictly for informational and educational purposes and should not be interpreted as medical advice. HC Biologics does not take any responsibility for distribution or use of these products. HC Biologics is not responsible for the misuse of these products.
