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Created on 09.29
Confidently Meeting FDA Compliance Challenges: ASCH's Integrated Solution for Skin Barrier Integrity Testing
Confidently Meeting FDA Compliance Challenges:ASCH's Integrated Solution for Skin Barrier Integrity Testing
In generic drug applications (ANDAs) for locally acting topical drug products, the In Vitro Permeation Test (IVPT) is a key step in assessing bioequivalence (BE). One of the factors that determines the success or failure of IVPT experiments is the in vitro skin barrier integrity test. According to the Technical Guidelines for In Vitro Release (IVRT) and In Vitro Permeation (IVPT) Studies of Locally Acting Chemical Generic Drugs (Trial) issued by China's CDE in June 2025, and the FDA's In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs issued in October 2022, the two testing methods TEWL and TEER have been recommended and specifically highlighted for their rapid and non-destructive characteristics.
However, many dermatological drug developers and CROs are facing challenges in actual practice: applicants need to submit, in the ANDA application documents (attached to the IVPT method development report), the calibration information for the transepidermal water loss meter used, in order to justify the TEWL measurement technical procedures established by the laboratory. Facing stringent regulatory requirements, how can R&D companies break through? ASCH, drawing on its deep dermatological engineering heritage, has provided a targeted solution.
Brand History and Evolution
Chemical Equipment Co., Ltd., founded in 1980, and Asahi Biomed Co., Ltd., founded in 1994, formally merged in 2016 to establish the new ASCH Co., Ltd. The merged ASCH carries forward the technical foundation that the original Asahi Biomed built in dermatological science testing — including closed-chamber transepidermal water loss measurement, transepithelial electrical resistance testing, and conductance-based skin moisture measurement technologies — under the corporate mission of "developing high-end biomedical measurement instruments that meet customer needs." Thanks to decades of persistent, dedicated R&D and manufacturing, its products perform well in resisting environmental interference and in precise measurement of small areas.
VAPOSCAN AS-VT150RSN Transepidermal Water Loss Meter AS-TZ1 Transepithelial Electrical Resistance Tester |
As a flagship product built by ASCH specifically for demanding R&D laboratories, the VAPOSCAN closed-chamber transepidermal water loss meter meets the FDA's requirements for IVPT testing and is suitable for research related to ANDA submissions. Over the past 10 years (2015–2025), more than 300 SCI papers published in China and abroad have used the VAPOSCAN Transepidermal Water Loss Meter, and the brand's professional performance has earned broad recognition in the skin testing research field.
Three compelling reasons for R&D users:
1. Closed-chamber design reduces environmental interference
The VAPOSCAN Transepidermal Water Loss Meter adopts proprietary closed-chamber sensor technology refined through continuous optimization and iteration. When the probe contacts excised skin (or the donor chamber), an independent microenvironment isolated from external airflow is rapidly formed inside. This shields out the spurious fluctuations caused by environmental changes in conventional instruments, substantially reduces the coefficient of variation (CV) of measurements, and helps improve the accuracy and stability of TEWL data.
2. Custom-designed for IVPT experiments, reducing measurement error
FDA regulations explicitly point out that the distance between the probe and the skin, probe alignment control, and heat transfer from the hand to the probe can all introduce data measurement errors. The VAPOSCAN offers an optional test probe specially designed for Franz diffusion cells (Franz Cell). Researchers simply place the probe vertically into the donor chamber each time, which guarantees a consistent measurement height — there are no alignment control issues, and no measurement deviation caused by heat transfer at the grip position.
3. Calibration records for compliance audit documentation
Drug review is based on data. Calibration records (the VAPOSCAN factory TEWL calibration certificate plus periodic calibration verification report records), together with experimental measurement data, constitute the evidence chain for Data Integrity — demonstrating that the instrument was in proper working condition during the experiment and facilitating the preparation of submission documents.
Established Industry Reputation
With stable measurement performance, ASCH's skin testing instruments are widely adopted in the pharmaceutical industry, spanning skin science research, cosmetic efficacy evaluation, pharmacological safety assessment, and other fields. Collaborating users include:
WuXi AppTec, Hengrui Pharmaceuticals, China Resources Sanjiu, Huapont Pharmaceutical, Zhiyuan Pharmaceutical, Fuyuan Pharmaceutical, Jiudian Pharmaceutical, Chia Tai Tianqing, Humanwell Healthcare, Medicilon, Lunan Pharmaceutical, North China Pharmaceutical, GeneScience Pharmaceuticals, Rohto; Botanee, Jiaheng Household Chemicals, Fudan University, Shenyang Pharmaceutical University, Tianjin University of Traditional Chinese Medicine, and the Sichuan Institute for Drug Control.
Labcan Scientific Supplies (Shanghai) Co., Ltd. — Your R&D Partner
In IVPT research, losing control of details means losing compliance. Labcan Scientific Supplies (Shanghai) Co., Ltd., as ASCH's officially authorized agent, provides you with localized support:
· Stock availability and demo units: VAPOSCAN demonstrations and trial use are available, letting you witness VAPOSCAN's measurement stability and consistency firsthand.
· Factory-level after-sales and calibration: an officially authorized annual calibration service channel helps keep your instrument's measurement accuracy consistent at all times.
· Worry-free after-sales: rapid technical response helps the instrument run stably throughout long testing cycles, supporting your project's R&D schedule.
Accelerate your topical formulation development — start with precise skin barrier integrity testing.
For a complete solution for dermatological drug R&D, technical documentation, and instrument quotations, contact us to schedule a demonstration and live trial, and advance your R&D work efficiently.
We are committed to excellence in everything we do and look forward to working with you!
We are committed to excellence in everything we do and look forward to working with you!
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+86 15317727424
+86 18016316889 (Same number for WeChat)
+86 15317727424
+86 18016316889 (Same number for WeChat)
info@labcan.cn
ligaojing@kerunsci.com
info@labcan.cn
ligaojing@kerunsci.com
Room 701 702, Block B, Yaoguang Central International Building, No. 2888 Qilianshan South Road, Putuo District, Shanghai
Room 701 702, Block B, Yaoguang Central International Building, No. 2888 Qilianshan South Road, Putuo District, Shanghai
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