The cell therapy industry is accelerating toward large-scale production and commercialization. Serum substitute As a key alternative to fetal bovine serum, it is increasingly attracting industry attention. However, as a human‑derived biological product, compliance and safety remain non‑negotiable red lines. In the face of an increasingly stringent regulatory landscape, how can we rationally identify truly reliable… hPL Products have become a core issue of shared concern across the entire industry chain, from upstream to downstream.

Previously, the FDA had issued relevant guidance documents on excipients used in cell and gene therapies. On November 1, 2026, the national standard “Excipients Used in the Production of Biotechnology Cell Therapy Products and Gene Therapy Products” (GB/T 47528-2026) will officially come into effect. This is China’s… CGT The first national standard in this field specifically addressing production auxiliary materials, which adopts ISO 20399:2022 as an equivalent, fills a regulatory gap.

The core of this standard lies in establishing a risk-based assessment and management system. For auxiliary materials containing human-derived components, such as serum substitutes, three main lines are clearly defined:

End-to-end risk management—suppliers and users must jointly implement end-to-end control over sourcing, manufacturing processes, and product characteristics.

Viral safety takes priority—cell therapy products cannot be terminally sterilized, and human‑derived materials must undergo a dedicated viral risk assessment; source‑level control serves as the first line of defense.

Supplier traceability—standards impose systematic requirements on supplier audits, quality management systems, and traceability documentation. Selecting compliant, auditable suppliers is itself a critical step toward meeting national standards.

The standard also explicitly states that users are responsible for ensuring the compliance of ancillary materials throughout their manufacturing processes; the quality and safety of these materials directly determine the quality of the final cell therapy product. The regulations specifically emphasize that, when human‑derived blood products are used in the production of ancillary materials, virus removal or inactivation should be performed. Conducting supplier audits is an effective approach to enhancing confidence in material quality.

As such, a qualified hPL product is far from a mere “culture‑supplement additive”; it demands comprehensive capabilities in raw‑material traceability, pathogen safety, process standardization, and batch‑to‑batch consistency. Any weakness in these areas can significantly amplify end‑product risks.

The Hycells Bio team has long been deeply engaged in the fields of cell and gene therapies (CGT) and large‑molecule drugs. When selecting hPL raw materials, Hycells consistently adheres to the principle that “source determines safety.” The samples used in production are rigorously collected in accordance with applicable standards, and all donors undergo stringent screening to eliminate the risk of disease transmission at the very source. More importantly, from the donor’s informed consent forms and ethical approvals to… GCP Under this framework, Hycells has established a fully traceable documentation chain for clinical‑grade sample collection, ensuring that every specimen is meticulously accounted for. Compared with the industry’s longstanding reliance on the conventional model of “expired blood supplies from blood banks,” this represents a structural, generational upgrade.

Specifically, Hycells enjoys four major advantages on the raw-materials front:

Fresh samples, superior performance — Imported hPL typically relies on expired blood products from blood banks (which have already undergone aggregation and degradation after 5–7 days of room‑temperature storage), allowing only control of total protein levels but failing to accurately quantify the initial platelet concentration. Case studies from overseas brands demonstrate that one U.S. manufacturer experienced a marked decline in cell expansion capacity after switching its raw material to stockpiled, cryopreserved platelets; performance only recovered once the original raw material was reinstated, underscoring the decisive impact of raw material freshness on product performance.

Standardized sample collection ensures robust quality control. — Deploy dedicated collection equipment at partner hospitals to achieve standardized, end-to-end process control; establish fixed in‑house quality standards for the concentration of single‑donor platelets upon receipt, thereby anchoring the quality baseline at the source.

Mixed-batch scaling, with controllable inter-batch variations. ——hPL was prepared by separately mixing samples of 10 L, 20 L, and 100 L, for use in MSC After culture up to passage P6, the coefficient of variation (CV) for cell expansion was consistently kept below 20%, demonstrating excellent batch-to-batch consistency in a large‑scale pooled‑sample format.

The donor population is uniform, and batch-to-batch consistency is improved. — The donors are predominantly healthy, with favorable baseline characteristics and a well-defined population profile, thereby indirectly enhancing the batch-to-batch consistency of the raw material.

In response to the new national standards, Hycells has already completed its strategic positioning. The company closed a pre‑A round of financing worth tens of millions of yuan in 2025, focusing on advancing GMP‑grade product iterations and expanding production capacity. It has established an integrated service framework encompassing “sample services—specialized products—technology service platform,” with several products breaking foreign monopolies. Hycells’s core competitive advantage lies in establishing a seamless end‑to‑end closed loop that covers “compliant clinical sample acquisition—full‑chain document traceability—supporting regulatory submission materials.” Leveraging its deep expertise in CGT pipeline services, Hycells has cumulatively supported clients in filing more than 30 IND applications and two BLA submissions, including industry‑leading cases involving dual filings in both China and the United States. Behind these figures is the continued recognition from regulatory authorities of Hycells’s commitment to sample compliance and data integrity. 
 

From a compliance perspective: The project has completed registration with the Health Commission and obtained institutional review board approval, with the research objectives clearly focused on the development and production of hPL. Throughout the entire process—donor health assessment, screening, collection, informed consent, and cold-chain transportation—comprehensive records have been maintained in full compliance with GCP requirements.

For hPL products, the pathogen‑inactivation process is a critical differentiator between high‑quality and lower‑quality offerings. As serum substitutes derived from blood, the industry has previously encountered risk incidents: a leading international competitor was found to be positive for HHV—though this virus is not included in its standard testing panel—and domestic culture‑medium users have also reported high positivity rates for B19 when using certain imported batches, highlighting a misalignment between overseas testing protocols and domestic regulatory requirements. Meanwhile, to mitigate batch‑to‑batch variability, the industry commonly employs pooled donor pools ranging from 5 to 200 individual donors; while this approach enhances product consistency, it simultaneously amplifies both the likelihood and diversity of potential pathogen contamination. In response to this challenge, conventional gamma‑irradiation can inactivate viruses but may also reduce growth‑factor activity, cause product turbidity, and diminish cell‑expansion efficiency, sometimes necessitating the addition of protein stabilizers and introducing new risks.

Hycells consistently adopts an R&D approach that balances efficacy with safety. Its proprietary pathogen-inactivation process efficiently inactivates viruses while virtually preserving the activity of key growth factors in hPL, such as EGF, PDGF, and TGF-β, thereby ensuring optimal cell expansion outcomes.

Across both domestic and international markets, only a handful of manufacturers are capable of consistently mass‑producing irradiated serum substitutes. Hycells has broken the deadlock with cutting‑edge technology: third‑party validation confirms a mainstream virus inactivation rate exceeding 99.999%, surpassing national standards; moreover, its performance in post‑irradiation cell expansion and viability maintenance matches that of imported non‑irradiated serum substitutes, giving it an unequivocal edge over competing irradiated products. This standalone inactivation unit is more than just a processing step—it fundamentally severs the root cause of human‑derived viral contamination, elevating proactive defense from reactive mitigation.

The national standard emphasizes the concept of “risk‑based assessment,” and on‑site audits are the most effective means of conducting such assessments. Hycells not only maintains a GMP quality system that meets both Chinese and U.S. regulatory requirements, but also welcomes customers to conduct on‑site audits with an open and transparent approach. During the audit, the following core modules can be systematically reviewed: first, a comprehensive traceability system covering the entire supply chain, from raw material receipt to finished product release; second, complete validation data records for virus inactivation and removal processes; and third, production environments and quality management procedures that rigorously align with current domestic and international standards. Compliance is not an abstract promise—it is embodied in verifiable data embedded in every test report and institutionalized through standardized execution at each stage of production.

Wuxi Hycells GMP Production Base 
 

As the industry shifts from “scale-driven” to “quality‑defined,” the competitive moat for a serum substitute has long ceased to hinge solely on individual performance metrics; it now rests on suppliers’ depth of understanding and precision in managing risks across the entire end‑to‑end value chain—from donor to patient. Leveraging years of strategic expertise in compliant biobanking and deep, industry‑insight‑driven knowledge embedded in its CGT pipeline, Hycells has forged HiXpan. ^® Cell culture additives—more than just a functional product, they constitute a compliant cell‑culture infrastructure that is traceable, auditable, and scalable. In an era when industry standards are steadily tightening, only long‑term visionaries who have “institutionally prepared from the ground up” can achieve sustained, steady progress.

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, anyone who orders the  HiXpan ^® Cell culture additives (universal across all grades): In addition to the standard price‑and‑discount structure, for every full 5 bags or bottles purchased in a single order, you’ll receive an extra bag or bottle of the same grade and specification—buy more, get more, with 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.

More HiXpan ^® For product details on cell culture additives, please contact Ms. Yu, our Business Manager (Tel/WeChat: 13061948224). Scan the QR code below to request a free sample.