(II) Security Assurance Section | Safety First, Defense Prioritized
Release Date:
2026-09-08 09:19
Compliance‑driven traceability addresses the fundamental question of “where the raw materials come from”; yet the real challenge with human‑derived materials lies in a deeper inquiry: “are they sufficiently safe?” The new national standard has placed viral safety at the forefront, explicitly mandating dedicated viral risk assessments for human‑derived materials. Within this framework, Hycells’s approach does not rely on isolated, end‑point testing; instead, it starts at the process level, establishing a systematic, proactive defense system. This article will focus on Hycells’s key technological breakthroughs in virus inactivation and pathogen‑safety control.
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 introducing pathogens. In the face of these associated risks and challenges, Hycells has never compromised on its manufacturing standards—relying on more sophisticated design to deliver on its promise of enhanced safety.
Virus Removal Process : : The perfect balance between viral inactivation and activity preservation
Multi-donor pooling is a common practice in the hPL industry to enhance batch-to-batch consistency; however, this approach simultaneously increases both the likelihood and diversity of pathogen contamination. Even more concerning is the misalignment between overseas testing protocols and domestic regulatory requirements: for instance, a leading international competitor once detected HHV positivity, despite this virus not being included in its standard testing panel, while a top domestic culture‑media manufacturer relies on imported… Blood substitute At that time, a high positivity rate for B19 was also detected. These real-world cases repeatedly underscore that, when risks arise, relying solely on post‑exposure testing is far from sufficient to ensure safety.
Hycells’s safety philosophy is to establish an “active defense”–based pathogen inactivation system. Our independently developed viral clearance process is centered on achieving broad-spectrum, high‑efficiency virus removal.
At the very outset of designing the virus inactivation standards, Hycells established a technical approach far exceeding industry norms. The indicator virus we selected is mouse minute virus ( MVM ), is widely recognized as one of the most challenging representative strains in the field of irradiation‑based inactivation, with resistance far exceeding that of the model viruses typically used in conventional processes. By contrast, some competing products in the industry rely on relatively easily inactivated model viruses such as vesicular stomatitis virus (VSV), Sindbis virus (SINV), and pseudorabies virus (PRV) for validation; even when they achieve reductions greater than 6 logs—well above the guideline’s minimum requirement of ≥4 logs—their inactivation difficulty and underlying technological sophistication still fall short of those of MVM.
Hycells consistently uses highly resistant MVM as the benchmark for validation, which not only underscores our relentless pursuit of product safety but also ensures that every serum substitute we deliver has undergone rigorous testing far exceeding industry standards, thereby providing… CGT The craftsmanship delivers truly reliable security.
In practical validation, MVM is employed as Indicative virus The irradiation process demonstrates particularly outstanding performance at doses of 4 kGy and 5 kGy, achieving a virus reduction of 4 to 5 log units (LRV 4–5), which corresponds to a reduction in viral load by 99.99% to 99.999%. This outcome not only meets the industry‑recognized threshold for efficacy but also exceeds the ≥4 logs mandatory standard stipulated in China’s “Guiding Principles for Viral Removal/Inactivation Technologies and Validation in Blood Products,” thereby establishing a robust safeguard for product safety based on rigorous data.
More critically, there is a differentiated technological advantage. Unlike conventional Cobalt‑60 irradiation, which severely disrupts protein structures—resulting in product turbidity and a precipitous decline in cellular expansion efficiency, while also necessitating the addition of protein stabilizers that introduce new risks—Hycells’s customized irradiation process efficiently inactivates viruses while effectively preserving the structural integrity of platelet proteins and exosomes, with minimal impact on the activity of key growth factors such as EGF, PDGF, and TGF‑β.
Empirical data show that the irradiated blood‑based medium from Hycells exhibits nearly identical MSC expansion capacity compared with non‑irradiated media, while demonstrating a significant advantage over competing products on a year‑over‑year basis. For the culture of NK cells and γδ T cells, its purity is comparable to that of non‑irradiated media, though the fold expansion is slightly lower; nonetheless, it still offers a significant advantage versus competitors on a year‑over‑year basis.
Hycells HiXpan ® The cell culture additives product line offers a multi-tiered portfolio to meet the diverse needs of various application scenarios. Customers can flexibly select from the following product lines based on cell type, culture system, and the specific requirements of their development stage, thereby addressing the differentiated demands of different process pathways.
HiXpan ® Detailed List of Cell Culture Additives
A three-tiered virus testing system eliminates testing blind spots.
Hycells has established a three-tier viral testing system—“donor–intermediate product–final product”—systematically eliminating testing blind spots:
Compared with certain competitors on the market that rely solely on raw reports from blood banks and overlook the limitations of end-product testing, Hycells has established a triple‑testing system that is more comprehensive and subject to independent validation, thereby setting a clear industry benchmark in this field.
The industry as a whole faces endotoxin risks, and a single classic case illustrates the issue: if expired platelets are stored at room temperature for nearly five days, the risk of bacterial proliferation rises sharply. Even though subsequent freeze–thaw cycles and 0.22-μm filtration can remove viable bacteria, the endotoxins they produce cannot be eliminated by standard filtration and will enter the final human platelet‑derived plasma (hPL) product, resulting in endotoxin levels exceeding regulatory limits. In CGT cell‑manufacturing processes, this translates into batch release failure and may pose significant risks to Investigational New Drug (IND) submissions.
Faced with such stringent safety challenges, Hycells has established a comprehensive viral‑safety defense spanning the entire process, leveraging a combined approach of a “three‑tier testing system plus a proprietary irradiation process.” This system not only aligns with but also surpasses the three‑layer protection standards mandated by the new national standard—namely, source‑level screening, viral inactivation validation, and end-to-end traceability—thereby achieving an optimal balance between safety and biological activity.
Wuxi Hycells GMP Production Base
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, anyone who orders the Hycells HiXpan ® Cell culture additives (universal across all grades): In addition to the existing full‑price discounts, for every 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 representative (Tel/WeChat: 13061948224). Scan the QR code below to request a free sample.
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