(1) Compliance and Traceability Section | Establishing a Foundation of Compliance, Ensuring Source Tracing
Release Date:
2026-09-08 09:11
With the new national standard set to take effect soon, in order to… CGT Auxiliary materials have established clear red lines—“end-to-end traceability” is no longer a bonus but a mandatory requirement. For serum substitutes, compliance begins not with the finished‑product test report, but at the very moment when the donor is connected to the blood‑collection device. This article focuses on how Hycells has moved its quality system upstream to the hospital level, translating compliance requirements into concrete, actionable steps starting at the sample‑collection stage, thereby building an audit‑ready chain of trust.
On November 1, 2026, the national standard “Biotechnology — Auxiliary Materials Used in the Production of Cell Therapy and Gene Therapy Products” (GB/T 47528-2026) will officially come into effect. This is the first national-level standard in China’s CGT sector specifically addressing auxiliary materials. Its core focus is not on listing technical specifications, but on establishing a risk‑based management system—true compliance entails end-to-end traceability across the entire value chain, from sample to culture vessel.
For “live drugs” that cannot undergo terminal sterilization, every drop of hPL introduced into the culture system must withstand the most rigorous safety scrutiny. This is not merely a matter of quality management; it also bears on the success or failure of the IND application, the commercialization timeline, and, ultimately, patient safety.
While the industry is anxious about “how to comply with the new national standard,” Hycells has already embedded compliance into its product DNA. Its independently developed HiXpan… ® Cell culture additives, designed with end-to-end compliance in mind, meet all the stringent requirements of the new national standard for biogenic excipients, redefining the safety baseline for hPL at its very source.
Abandon “expired blood” and establish a “clinical-grade fresh single-donor” standard.
As a human‑derived biological material, platelet quality begins to decline the moment they leave the donor. The “expired blood” commonly used in the industry—platelets that have undergone aggregation and disintegration after being stored at room temperature for 5 to 7 days—suffers from inherent deficiencies in both potency and safety. Hycells resolutely abandoned this industry standard and instead established a source‑level criterion for clinical‑grade, freshly collected, single‑donor platelets.
Source Control: Dedicated collection equipment is deployed at partner hospitals, with dedicated personnel overseeing the entire process according to standardized protocols, ensuring that platelets remain fresh and highly active upon receipt, thereby safeguarding raw material quality at the physical level.
24-hour rigid time‑sensitive management: We consistently use freshly collected samples, strictly limiting the time window between blood draw and raw material processing to within 24 hours, thereby completely abandoning conventional cryopreservation methods. This choice is underpinned by robust scientific evidence: inherent inter‑individual variability exists, and fresh samples best preserve the native profile of bioactive molecules, yielding markedly superior outcomes in downstream cell culture compared to cryopreserved sources.
Standardized screening of the donor population: Select a donor population with good health and a narrow age range to reduce the risk of batch-to-batch variability arising from donor heterogeneity, thereby laying a solid foundation for inter‑batch consistency.
Shifting the quality system to the hospital level.
To comprehensively mitigate the dual risks of compliance and quality posed by “expired blood supplies” at blood stations, Hycells has extended its quality management system to the hospital‑level collection stage:
All collection procedures comply with GCP Management standards are implemented by experienced healthcare professionals using their own equipment in accordance with established protocols, ensuring the process is safe and well‑controlled.
The total collection volume and platelet concentration are precisely controlled via the device’s software, ensuring that the incoming raw material meets the predefined QA standards.
A comprehensive health assessment, including medical and travel histories, is conducted for the donor, and tests for HBV, HCV, HIV, CMV, … are completed. EBV Conduct testing for systemic infectious disease biomarkers and issue medical examination reports that meet IND‑submission standards; at the same time, uphold the principle of fully informed consent, placing donor rights and interests first.
A fully auditable document chain ensures hassle-free dual filing in both China and the U.S.
HiXpan ® What is provided is not merely a single vial of reagent, but rather a comprehensive system that spans donor screening, collection records, manufacturing parameters, and quality control ( COA ）、A complete, transparent, and auditable compliance documentation chain covering virus inactivation validation and long-term stability. The digital footprint—from donor ID to production batch—is fully traceable, providing robust support for dual‑submission audits in both China and the United States.
In a period of tightening regulation, choose HiXpan. ® Cell culture additives represent the selection of a compliant infrastructure aligned with international standards—choosing hPL is not merely choosing a “culture‑medium additive,” but rather opting for a means of transferring risk. Compliance begins with traceability and hinges on rigorous implementation. Only when every step at the raw‑material stage can withstand audit scrutiny does safety rest on a truly solid foundation—and this, in turn, sets the stage for the next topic: how to leverage technological solutions to elevate safety from “passive testing” to “proactive defense.”
HiXpan ® Limited-Time Gratitude Giveaway on Cell Culture Additives
On the occasion of Hycells’s fifth anniversary, in gratitude for the longstanding trust and support of our valued new and existing customers, we are pleased to launch a limited-time appreciation campaign:
From today until December 1, 2026, when you place an order for Hycells HiXpan® Cell Culture Additive (compatible with all grades), in addition to the standard discount, you will receive one extra bag or bottle of the same grade and specification for every full five bags or bottles purchased per order. The more you buy, the more you get—no upper limit.
Friendly reminder: Special‑price orders that have already benefited from a discount lower than the original rate are not eligible for this gift‑giving promotion. The final interpretation of this promotion rests with Wuxi Hycells Biotechnology Co., Ltd.
For more details on HiXpan® cell culture additives, please contact Ms. Yu, our sales representative (Tel/WeChat: 13061948224). Scan the QR code below to request a free sample.
Welcome to apply for a trial.
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(II) Security Assurance Section | Safety First, Defense Prioritized
Compliance‑driven traceability establishes a clear “identity” for the product, but the real test lies in safety. While a multi‑donor pooling strategy ensures batch‑to‑batch consistency, it also inevitably elevates the risk of pathogen introduction. In the face of these associated risks and challenges, Heyousheng has never compromised on its manufacturing standards—relying on more precise design to deliver on its promise of enhanced safety.
This article will examine how He Yousheng proactively integrates the quality management system into the hospital setting, translating compliance requirements into concrete, actionable practices starting at the sample collection stage, thereby establishing a trust‑based chain that can withstand audit scrutiny.
In selecting hPL raw materials, Heyousheng consistently upholds the principle that “safety is determined at the source.” The samples used in production are rigorously collected in accordance with applicable standards and undergo stringent donor screening, effectively mitigating the risk of disease transmission at the very outset. Moreover, from informed consent forms and ethical approvals to clinical‑grade collection under the GCP framework, Heyousheng has established a fully traceable documentation chain, ensuring that every sample is accounted for and verifiable. In contrast to the industry’s longstanding reliance on the conventional model of using expired blood supplies from blood banks, this approach represents a structural, generational upgrade.
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