Bio-Techne's Simple Western鈩� Technology Utilized in Recent FDA Approval of 窜贰痴础厂碍驰狈鈩� Cell-Based Gene Therapy
Bio-Techne (NASDAQ: TECH) announced that its Simple Western鈩� Technology was instrumental in supporting the FDA approval of 窜贰痴础厂碍驰狈鈩�, 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鈩� 猫 stata fondamentale per supportare l'approvazione FDA di 窜贰痴础厂碍驰狈鈩�, la prima terapia genica autologa a base cellulare per l'epidermolisi bollosa distrofica recessiva (RDEB), sviluppata da Abeona Therapeutics.
La piattaforma Simple Western 猫 stata scelta per le sue capacit脿 superiori nel rilevare e quantificare il Collagene VII, una proteina cruciale per il test di potenza di ZEVASKYN. I vantaggi della tecnologia includono sensibilit脿 a livello di picogrammi, riproducibilit脿 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) anunci贸 que su tecnolog铆a Simple Western鈩� fue fundamental para apoyar la aprobaci贸n de la FDA de 窜贰痴础厂碍驰狈鈩�, la primera terapia g茅nica aut贸loga basada en c茅lulas para la epiderm贸lisis bullosa distr贸fica recessiva (RDEB), desarrollada por Abeona Therapeutics.
La plataforma Simple Western fue seleccionada por sus superiores capacidades para detectar y cuantificar el Col谩geno VII, una prote铆na cr铆tica para las pruebas de potencia de ZEVASKYN. Las ventajas de esta tecnolog铆a incluyen sensibilidad a nivel de picogramos, reproducibilidad y requerimientos m铆nimos de muestra, lo que la hace esencial para las pruebas de liberaci贸n de lotes conforme a GMP tanto de vectores virales como de componentes de terapia celular.
La plataforma super贸 con 茅xito complejos desaf铆os anal铆ticos en la estandarizaci贸n y desarrollo de ensayos, especialmente en la evaluaci贸n de la estructura terciaria del Col谩geno VII en condiciones no desnaturalizantes.
Bio-Techne (NASDAQ: TECH)電� 鞛愳偓鞚� Simple Western鈩� 旮办垹鞚� Abeona Therapeutics臧� 臧滊皽頃� 鞐挫劚 鞙犾爠靹� 靾橅彫靹� 響滍敿氚曤Μ歃�(RDEB) 旃橂毳� 鞙勴暅 斓滌磮鞚� 鞛愱皜 靹疙彫 旮半皹 鞙犾爠鞛� 旃橂鞝滌澑 窜贰痴础厂碍驰狈鈩�鞚� FDA 鞀轨澑鞚� 歆�鞗愴晿電� 雿� 欷戩殧頃� 鞐暊鞚� 頄堧嫟瓿� 氚滍憸頄堨姷雼堧嫟.
Simple Western 頂岆灚韽检潃 旖滊澕瓴� VII鞚� 瓴�於� 氚� 鞝曤焿鞐� 韮侅洈頃� 靹彪姤鞚� 氤挫湢頃橃棳 ZEVASKYN鞚� 須姤 鞁滍棙鞐� 頃勳垬鞝侅澑 旮办垹搿� 靹犿儩霅橃棃鞀惦媹雼�. 鞚� 旮办垹鞚� 頂检綌攴鸽灗 靾橃鞚� 臧愲弰, 鞛槃靹�, 斓滌唽 靸橅攲 鞖旉惮霟� 霌膘潣 鞚挫爯鞚� 鞝滉车頃橃棳 氚旍澊霟姢 氩№劙 氚� 靹疙彫 旃橂 甑劚 鞖旍唽鞚� GMP 欷�靾� 氚办箻 毽措Μ鞀� 鞁滍棙鞐� 頃勳垬鞝侅瀰雼堧嫟.
鞚� 頂岆灚韽检潃 韸鬼瀳 牍勲硛靹� 臁瓣贝鞐愳劀 旖滊澕瓴� VII鞚� 3彀� 甑“ 韽夑皜毳� 韽暔頃� 響滌頇� 氚� 攵勳劃氩� 臧滊皽鞐愳劀 氤奠灐頃� 攵勳劃鞝� 瓿检牅毳� 靹标车鞝侅溂搿� 攴闺车頄堨姷雼堧嫟.
Bio-Techne (NASDAQ: TECH) a annonc茅 que sa technologie Simple Western鈩� a jou茅 un r么le cl茅 dans le soutien 脿 l'approbation par la FDA de 窜贰痴础厂碍驰狈鈩�, la premi猫re th茅rapie g茅nique autologue 脿 base cellulaire pour l'茅pidermolyse bulleuse dystrophique r茅cessive (RDEB), d茅velopp茅e par Abeona Therapeutics.
La plateforme Simple Western a 茅t茅 choisie pour ses capacit茅s sup茅rieures 脿 d茅tecter et quantifier le Collag猫ne VII, une prot茅ine essentielle pour les tests de puissance de ZEVASKYN. Les avantages de cette technologie incluent une sensibilit茅 au niveau du picogramme, une reproductibilit茅 et des exigences minimales en 茅chantillons, ce qui la rend indispensable pour les tests de lib茅ration de lots conformes aux BPF, tant pour les vecteurs viraux que pour les composants de th茅rapie cellulaire.
La plateforme a surmont茅 avec succ猫s des d茅fis analytiques complexes dans la standardisation et le d茅veloppement des essais, notamment dans l'茅valuation de la structure tertiaire du Collag猫ne VII en conditions non d茅naturantes.
Bio-Techne (NASDAQ: TECH) gab bekannt, dass seine Simple Western鈩� Technologie eine entscheidende Rolle bei der Unterst眉tzung der FDA-Zulassung von 窜贰痴础厂碍驰狈鈩� spielte, der ersten autologen zellbasierten Gentherapie f眉r die rezessive dystrophe Epidermolysis bullosa (RDEB), entwickelt von Abeona Therapeutics.
Die Simple Western-Plattform wurde aufgrund ihrer 眉berlegenen F盲higkeiten zur Erkennung und Quantifizierung von Kollagen VII ausgew盲hlt, einem wichtigen Protein f眉r die Wirksamkeitstests von ZEVASKYN. Zu den Vorteilen der Technologie z盲hlen Sensitivit盲t im Pikogramm-Bereich, Reproduzierbarkeit und minimaler Probenbedarf, was sie unerl盲sslich f眉r 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 terti盲ren 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鈩� platform in the rapidly growing cell and gene therapy space. The technology played a crucial role in securing FDA approval for 窜贰痴础厂碍驰狈鈩�, 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 鈥� 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聽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
(NASDAQ: TECH)
Contact: David聽Clair, Vice President, Investor Relations & Corporate Development
[email protected]
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 窜贰痴础厂碍驰狈鈩� (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
窜贰痴础厂碍驰狈鈩�, Abeona Assist鈩�, Abeona Therapeutics庐, and their related logos are trademarks of Abeona Therapeutics Inc.
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FAQ
How did Bio-Techne's Simple Western Technology contribute to ZEVASKYN's FDA approval?
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What is ZEVASKYN and what condition does it treat?
Why was Bio-Techne's technology chosen for ZEVASKYN's development?
What makes Bio-Techne's Simple Western platform suitable for GMP compliance?
