Bio-Techne's Simple Western™ Technology Utilized in Recent FDA Approval of ZEVASKYN™ Cell-Based Gene Therapy
Bio-Techne (NASDAQ: TECH) announced that its Simple Western™ Technology was instrumental in supporting the FDA approval of ZEVASKYN™, the first autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB), developed by Abeona Therapeutics.
The Simple Western platform was chosen for its superior capabilities in detecting and quantifying Collagen VII, a critical protein for ZEVASKYN's potency testing. The technology's advantages include picogram-level sensitivity, reproducibility, and minimal sample requirements, making it essential for GMP-compliant lot release testing of both viral vector and cell therapy components.
The platform successfully overcame complex analytical challenges in standardization and assay development, particularly in evaluating Collagen VII's tertiary structure under non-denaturing conditions.
Bio-Techne (NASDAQ: TECH) ha annunciato che la sua tecnologia Simple Western™ è stata fondamentale per supportare l'approvazione FDA di ZEVASKYN™, la prima terapia genica autologa a base cellulare per l'epidermolisi bollosa distrofica recessiva (RDEB), sviluppata da Abeona Therapeutics.
La piattaforma Simple Western è stata scelta per le sue capacità superiori nel rilevare e quantificare il Collagene VII, una proteina cruciale per il test di potenza di ZEVASKYN. I vantaggi della tecnologia includono sensibilità a livello di picogrammi, riproducibilità e requisiti minimi di campione, rendendola essenziale per i test di rilascio lotto conformi alle GMP sia per il vettore virale che per i componenti della terapia cellulare.
La piattaforma ha superato con successo complesse sfide analitiche nella standardizzazione e nello sviluppo dei saggi, in particolare nella valutazione della struttura terziaria del Collagene VII in condizioni non denaturanti.
Bio-Techne (NASDAQ: TECH) anunció que su tecnología Simple Western™ fue fundamental para apoyar la aprobación de la FDA de ZEVASKYN™, la primera terapia génica autóloga basada en células para la epidermólisis bullosa distrófica recessiva (RDEB), desarrollada por Abeona Therapeutics.
La plataforma Simple Western fue seleccionada por sus superiores capacidades para detectar y cuantificar el Colágeno VII, una proteína crítica para las pruebas de potencia de ZEVASKYN. Las ventajas de esta tecnología incluyen sensibilidad a nivel de picogramos, reproducibilidad y requerimientos mínimos de muestra, lo que la hace esencial para las pruebas de liberación de lotes conforme a GMP tanto de vectores virales como de componentes de terapia celular.
La plataforma superó con éxito complejos desafíos analíticos en la estandarización y desarrollo de ensayos, especialmente en la evaluación de la estructura terciaria del Colágeno VII en condiciones no desnaturalizantes.
Bio-Techne (NASDAQ: TECH)는 자사의 Simple Western™ 기술이 Abeona Therapeutics가 개발한 열성 유전성 수포성 표피박리증(RDEB) 치료를 위한 최초의 자가 세포 기반 유전자 치료제인 ZEVASKYN™의 FDA 승인을 지원하는 데 중요한 역할을 했다고 발표했습니다.
Simple Western 플랫폼은 콜라겐 VII의 검출 및 정량에 탁월한 성능을 보유하여 ZEVASKYN의 효능 시험에 필수적인 기술로 선택되었습니다. 이 기술은 피코그램 수준의 감도, 재현성, 최소 샘플 요구량 등의 이점을 제공하여 바이러스 벡터 및 세포 치료 구성 요소의 GMP 준수 배치 릴리스 시험에 필수적입니다.
이 플랫폼은 특히 비변성 조건에서 콜라겐 VII의 3차 구조 평가를 포함한 표준화 및 분석법 개발에서 복잡한 분석적 과제를 성공적으로 극복했습니다.
Bio-Techne (NASDAQ: TECH) a annoncé que sa technologie Simple Western™ a joué un rôle clé dans le soutien à l'approbation par la FDA de ZEVASKYN™, la première thérapie génique autologue à base cellulaire pour l'épidermolyse bulleuse dystrophique récessive (RDEB), développée par Abeona Therapeutics.
La plateforme Simple Western a été choisie pour ses capacités supérieures à détecter et quantifier le Collagène VII, une protéine essentielle pour les tests de puissance de ZEVASKYN. Les avantages de cette technologie incluent une sensibilité au niveau du picogramme, une reproductibilité et des exigences minimales en échantillons, ce qui la rend indispensable pour les tests de libération de lots conformes aux BPF, tant pour les vecteurs viraux que pour les composants de thérapie cellulaire.
La plateforme a surmonté avec succès des défis analytiques complexes dans la standardisation et le développement des essais, notamment dans l'évaluation de la structure tertiaire du Collagène VII en conditions non dénaturantes.
Bio-Techne (NASDAQ: TECH) gab bekannt, dass seine Simple Western™ Technologie eine entscheidende Rolle bei der Unterstützung der FDA-Zulassung von ZEVASKYN™ spielte, der ersten autologen zellbasierten Gentherapie für die rezessive dystrophe Epidermolysis bullosa (RDEB), entwickelt von Abeona Therapeutics.
Die Simple Western-Plattform wurde aufgrund ihrer überlegenen Fähigkeiten zur Erkennung und Quantifizierung von Kollagen VII ausgewählt, einem wichtigen Protein für die Wirksamkeitstests von ZEVASKYN. Zu den Vorteilen der Technologie zählen Sensitivität im Pikogramm-Bereich, Reproduzierbarkeit und minimaler Probenbedarf, was sie unerlässlich für GMP-konforme Chargenfreigabetests sowohl der viralen Vektor- als auch der Zelltherapiekomponenten macht.
Die Plattform meisterte erfolgreich komplexe analytische Herausforderungen bei der Standardisierung und Assay-Entwicklung, insbesondere bei der Bewertung der tertiären Struktur von Kollagen VII unter nicht denaturierenden Bedingungen.
- Simple Western Technology proved crucial in FDA approval of first-in-class cell therapy
- Technology demonstrated superior capabilities in GMP-compliant testing and validation
- Successful partnership with Abeona Therapeutics enhances Bio-Techne's credibility in cell therapy development
- None.
Insights
Bio-Techne's Simple Western platform proves critical in FDA approval of groundbreaking cell therapy, showcasing its commercial value in complex biologics development.
This announcement represents a significant validation of Bio-Techne's Simple Western™ platform in the rapidly growing cell and gene therapy space. The technology played a crucial role in securing FDA approval for ZEVASKYN™, the first autologous cell-based gene therapy for recessive dystrophic epidermolysis bullosa (RDEB) - a rare genetic skin disorder with previously limited treatment options.
What's particularly noteworthy is Bio-Techne's technology was selected over traditional western blot methods specifically for its superior analytical capabilities: picogram-level sensitivity, reproducibility, speed, and minimal sample requirements. These attributes directly addressed the complex challenges in quantifying Collagen VII, the critical therapeutic target protein in ZEVASKYN therapy.
The platform's GMP compliance and ability to provide standardized, quantifiable data for lot release testing represents significant competitive differentiation in the biologics development space. This showcases Bio-Techne's technical leadership in supporting the stringent analytical requirements for novel therapeutics.
For investors, this approval demonstrates tangible commercial value of Bio-Techne's analytical platforms in supporting regulatory submissions. As cell and gene therapies continue advancing through clinical pipelines globally, the company is well-positioned to capture increased market share in the critical quality control and characterization segment of this high-growth sector. The endorsement from Abeona's Senior Director highlighting the platform's capabilities further strengthens Bio-Techne's positioning for similar partnerships with other therapy developers.
Abeona selected Simple Western over competing methods like traditional western blot for its speed, reproducibility, picogram-level sensitivity, and minimal sample volume requirements. The platform effectively detected both the trimeric and monomeric forms of Collagen VII, addressing the analytical challenges posed by the protein's size and structure and supporting the regulatory requirements for potency and consistency.
RDEB is a rare and debilitating genetic skin disorder caused by mutations in the COL7A1 gene, which leads to the misfolding of Collagen VII, a protein essential for skin integrity. Patients with RDEB suffer from severe blistering, chronic wounds, scarring, and are at significantly increased risk of life-threatening complications such as squamous cell carcinoma. The current standard of care focuses on symptomatic management, with no durable therapies available until now.
The Simple Western platform provided quantifiable, GMP-compliant data to ensure consistency of each autologous ZEVASKYN product lot, overcoming key challenges in analytical standardization, limited sample availability, and complex assay development. Abeona's final assay design was optimized through rigorous antibody selection, assay optimization, and use of an appropriate reference standard – enabled by Simple Western's automated and high-throughput capabilities.
"ZEVASKYN represents a significant milestone for patients with RDEB and for the field of cell-based gene therapy," said Will Geist, Bio-Techne's President, Protein Sciences Segment. "We are honored that our Simple Western platform helped Abeona develop and validate critical potency assays that supported FDA approval of this first-in-class therapy."
"Potency method development and validation were critical components in the clinical development and regulatory approval of ZEVASKYN," said Dr. Ann Durbin, Senior Director of Quality Control at Abeona Therapeutics. "The Simple Western platform was the best choice for our quality control laboratories due to the reproducibility, time-to-result, and GMP compliance of the platform. We collaborated with Bio-Techne's ProteinSimple to address the challenges of our large molecular weight analyte, Collagen VII, and our requirement to evaluate the protein's tertiary structure under non-denaturing conditions. With the capillary electrophoresis platform, our validated assay efficiently quantifies Collagen VII to support both release testing of autologous ZEVASKYN lots, and the release and stability testing of our viral vector. The partnership of scientists at Abeona and at ProteinSimple was instrumental in advancing ZEVASKYN as the first approved cell-based gene therapy for patients with RDEB."
About Bio-Techne
Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With hundreds of thousands of products in its portfolio, Bio-Techne generated approximately
About Bio-Techne Corporation (NASDAQ: TECH)
Contact: David Clair, Vice President, Investor Relations & Corporate Development
david.clair@bio-techne.com
612-656-4416
About Abeona Therapeutics
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company's fully integrated cell and gene therapy cGMP manufacturing facility in
ZEVASKYN™, Abeona Assist™, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc.
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SOURCE Bio-Techne Corporation
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