HiXpan® Cell Culture Additive | Meets Drug Regulatory Submission Requirements, Setting a New Benchmark for Industry Compliance
Release Date:
2025-11-14 16:09
Cell culture additives It refers to chemically defined or animal-free additives used in cell culture as substitutes for traditional animal sera, such as fetal bovine serum, with the aim of reducing batch-to-batch variability, minimizing contamination risks, and enhancing experimental reproducibility. Its composition typically includes growth factors, carrier proteins, trace elements, and other components, making it suitable for applications in vaccine production, biopharmaceuticals, regenerative medicine, and other fields.
End-to-end compliance lays the foundation for the safety of cell therapy.
HiXpan, innovatively developed by Hycells ® Cell culture additives have been officially launched. As the first domestically developed product specifically tailored for drug registration applications and rigorously compliant with GMP manufacturing standards, we are committed to providing a safe and reliable source of supply for the cell therapy field.
Hycells has established a comprehensive, end-to-end quality control system that exceeds industry standards, ensuring that every stage—from raw materials to the final product—meets stringent regulatory requirements for drug registration.
1. Traceable origins; donor safety is paramount.
Rigorous donor screening: A comprehensive health assessment is conducted, encompassing medical history, travel history, and lifestyle factors, and all relevant infectious disease markers—including HBV, HCV, HIV, TPPA, HTLV, CMV, and EBV—are thoroughly tested in accordance with national regulations.
Full Informed Consent: Uphold the ethical baseline by ensuring that every donor signs a consent form only after being fully informed and acting of their own free will, with the donor’s rights and dignity serving as the foundation of all our work.
2. Standardization and Normalization of the Entire Process
Standardized Collection Center: All collection procedures comply with GCP standards and are performed in a standardized manner by experienced, qualified healthcare professionals, ensuring the safety and controllability of the entire process.
Single Blood-Collection-Point Assurance: Strictly adhere to a single, traceable blood-collection-point source to completely eliminate pooled sampling and minimize the risk of potential cross-contamination.
3. Rigorous craftsmanship, with quality fully controllable throughout the process.
Compliant manufacturing process: A rigorously validated process is employed to ensure efficient release of growth factors while achieving thorough viral inactivation and elimination of immunogenicity.
Comprehensive quality testing: Each batch of product undergoes multiple critical quality-control assays, including endotoxin testing, sterility testing, and assessment of growth-factor activity and concentration, to ensure outstanding batch-to-batch consistency and stability.
4. Comprehensive compliance documentation support
Hycells provides a comprehensive, transparent, and auditable compliance documentation chain—covering donor screening, collection records, and a complete set of quality inspection reports—thereby providing robust support for clients in meeting the stringent regulatory reviews imposed by drug regulatory authorities. Support on-site customer audits.
Using starting materials from compliant sources is the cornerstone of ensuring the safety and efficacy of clinical therapies. Hycells is committed to partnering with you to advance the biopharmaceutical industry toward a more standardized, safe, and ethically sound future—through impeccable compliance and quality.
Quality Control Items
Sterile
pH value
Mycoplasma
Total protein content
Pathogen screening
Detection of Key Growth Factor Content
Endotoxin testing
Biological function assays:
Test MSC cells
NK cell testing
Data validation
HiXpan ® Data graph of MSC expansion using cell culture supplements
Group 1: Formula 1 + Hycells Cell Culture Supplement (Lot: 0528)
Group 2: Formula 2 + Competitor 1 cell culture supplement
Group 3: Formula 2 + Competitor 2 cell culture supplement
Group 4: Formula 2 + Hycells Cell Culture Supplement (Lot: 0318)
Group 5: Formula 2 + Hycells Cell Culture Supplement (Lot: 0528)
*Formula 1 and Formula 2 consist of the basal medium plus different combinations of activation factors, respectively.
Based on the amplification results, the Hycells cell culture supplement performs similarly to the Competitor 2 cell culture supplement and outperforms the Competitor 1 cell culture supplement. Moreover, different batches of the Hycells cell culture supplement exhibit comparable performance.
Microscopic observation images of MSC expansion from passage 2 to passage 3
P2 to P3 Passage Purity Assay for MSC Expansion
HiXpan ® Graph of NK Cell Expansion Efficiency with Cell Culture Additives
On the donor with relatively good amplification performance, Hycells HiXpan Registered trademark Compared with competing products, the cell culture supplement shows no significant difference in NK cell expansion fold and purity.
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The HiXpan® NK Serum-Free Culture Kit, Version 3.0, is manufactured in strict compliance with GMP standards, and its production system fully adheres to relevant guidelines and regulations, including the “818 Requirements,” positioning it for pharmaceutical‑grade manufacturing and applications.
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Email:monika@hys-bio.com
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