PRESS RELEASE: Tanvex CDMO is excited to share news about our alliance with Bora Pharmaceuticals. Combining Tanvex’s biosimilar development expertise and U.S. FDA-licensed commercial-scale facility in San Diego, California, with Bora’s extensive global CDMO capabilities, the alliance aims to provide comprehensive solutions to biologics CDMO customers around the world. https://lnkd.in/g2YRW_-j #PressRelease #CDMO #Pharma #biotech #Biologics #Biosimilars #Innovation #Biotech #Partnerships #tanvexCDMO #pharma #pharmaindustry #pharmaceutical #pharmaceuticalindustry #cdmo #contractmanufacturing
Tanvex CDMO
Pharmaceutical Manufacturing
San Diego, California 1,380 followers
Empowering Advancements in Novel Biologics and Biosimilars
Über uns
Founded in 2011, Tanvex BioPharma USA has been perfecting our skills in making biologic therapeutics more accessible to patients. To-date, we have successfully brought our first product to approval and two additional BLAs pending FDA approval. Our journey is defined by an unwavering commitment to excellence, innovation, and a passion for revolutionizing healthcare. We are now offering our technical and operational expertise to a greater audience by becoming a Contract Development and Manufacturing Organization – Tanvex CDMO. Nestled in the Sorrento Valley of San Diego, our 100,000 square feet, state-of-the-art campus serves as the nucleus of our operations. With Research and Development, and GMP manufacturing all under one roof, we foster smooth collaboration, maximizing efficiency at every step of the drug development process from pre-clinical to commercialization for both microbial and mammalian derived biologics. At the heart of Tanvex CDMO is our dedicated team of approximately 100 skilled professionals who bring unparalleled expertise to every project. Innovation thrives at Tanvex CDMO where we offer a comprehensive suite of services including: ● Cell line development (mammalian and microbial) ● Microbial fermentation process development and optimization ● Mammalian cell culture process development and optimization ● Pre-formulation and drug product formulation development ● Analytical development, method qualification/validation ● QC lot release testing & Stability study ● Clinical to Commercial GMP manufacturing (mammalian and microbial) ● Regulatory support From high-throughput (HT) workflows for process development to streamlined equipment for seamless process transfer to GMP production, coupled with single-use technology in our GMP manufacturing facilities, we are ready to advance your molecule to the next stage. Together, let's deliver groundbreaking advancements in biopharmaceuticals and make a lasting impact on healthcare worldwide.
- Website
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https://tanvexcdmo.com/
External link for Tanvex CDMO
- Industrie
- Pharmaceutical Manufacturing
- Größe des Unternehmens
- 51-200 Mitarbeiter
- Hauptsitz
- San Diego, California
- Typ
- Öffentliches Unternehmen
- Gegründet
- 2011
- Spezialitäten
- CDMO and Biosimilars
Standorte
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Primäre
10394 Pacific Center Ct
San Diego, California 92121, US
Employees at Tanvex CDMO
Aktualisierungen
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In the dynamic biopharma space, ensuring product integrity through process changes is crucial. The Tanvex CDMO team’s expertise in biologics uniquely positions us to offer robust risk-based comparability assessments. Our comprehensive approach leverages advanced analytical technologies and regulatory alignment to maintain product quality and compliance. Discover how we can help you navigate the complexities of biologic drug development. Read our full article and connect with us. We’re here to explore tailored strategies for your comparability assessment needs: https://lnkd.in/e4QQRdVt #biologics #cdmo #pharmaindustry #lifesciences
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Transform your biopharmaceutical vision into reality with Tanvex CDMO's expert formulation and drug product development services. Our team excels in crafting bespoke solutions that ensure your products are safe, stable, and effective. Our Formulation/DP Development Capabilities: - QbD Approach: Quick pre-formulation screening for rapid iterations - Streamlined Development: Fast design and testing of formulations - Optimization Focus: Emphasis on stability, quality, and safety From concept to commercialization, we provide the expertise and state-of-the-art tools needed to bring your biopharmaceutical products to life. Partner with Tanvex CDMO for a seamless and successful development & Formulation journey: https://lnkd.in/gtMgrj7Q #Biopharmaceuticals #DrugDevelopment #Pharmaceuticals #Biotech #StabilityTesting
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Explore Tanvex CDMO's Mammalian GMP Manufacturing: - Unmatched expertise in producing mammalian-derived biologics. - Innovative, scalable, and compliant processes ensure superior efficacy and safety. - State-of-the-art single-use bioreactors (SUB) to minimize risks and enhance efficiency. - Advanced purification technologies for streamlined production. Partner with Tanvex for successful scale-up of your biopharmaceuticals: https://lnkd.in/eAXJec7A #Biopharma #GMPManufacturing #Biologics
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PRESS RELEASE: Tanvex CDMO is excited to announce two pivotal achievements – FDA approval of NYPOZI™, our biosimilar to treat neutropenia in cancer patients, and FDA acceptance of our Biologics License Application (BLA) for TX-05, an investigational antineoplastic biologic targeting HER2-positive breast and gastric cancer. View the press release here: https://lnkd.in/esRveATf #PressRelease #Pharma #biotech #Biologics #Biosimilars #Innovation #Launch #Biotech #Partnerships #tanvexCDMO #pharma #pharmaindustry #pharmaceutical #pharmaceuticalindustry #cdmo #contractmanufacturing #CDMO
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Tanvex CDMO reposted this
Discover Tanvex CDMO's Microbial GMP Manufacturing: - Over a decade of expertise in microbial-derived therapeutics. - Optimized strain selection, fermentation, and purification for speed and cost-effectiveness. - Successful advancement from pre-clinical to commercialization. - FDA-inspected facility with capabilities in secreted and intracellular products. - Features include 150L stainless steel and 300L single-use fermentors, AKTA Ready, and Automated TFF Skids. Partner with Tanvex for successful scale up of your biopharmaceuticals: https://lnkd.in/gzj3GByH #MicrobialManufacturing #Biopharma #GMP
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Discover Tanvex CDMO's Microbial GMP Manufacturing: - Over a decade of expertise in microbial-derived therapeutics. - Optimized strain selection, fermentation, and purification for speed and cost-effectiveness. - Successful advancement from pre-clinical to commercialization. - FDA-inspected facility with capabilities in secreted and intracellular products. - Features include 150L stainless steel and 300L single-use fermentors, AKTA Ready, and Automated TFF Skids. Partner with Tanvex for successful scale up of your biopharmaceuticals: https://lnkd.in/gzj3GByH #MicrobialManufacturing #Biopharma #GMP
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Tanvex CDMO reposted this
Tanvex Biopharma USA, Inc's CEO, Henry Chen, shares insights into the company’s strategic expansion into Contract Development and Manufacturing Organization (#CDMO) services, their latest #FDA approval for a filgrastim biosimilar, and future focus on antibody-drug conjugates (ADCs). Chen discusses the challenges of #biosimilar production, regulatory compliance across regions, and the dual-location strategy integrating #Taipei and San Diego operations. Want to know how Tanvex is navigating these hurdles to deliver affordable biologic medicines? Read the full interview here 👉 https://bit.ly/4cYDgsX
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Happy 4th of July from Tanvex CDMO! As we celebrate this day of independence, freedom, and unity, let's take a moment to honor the spirit of innovation and collaboration that drives our industry forward. From all of us at Tanvex CDMO, we wish you a safe, joyous, and memorable Independence Day filled with celebration and reflection. 🇺🇸✨ #4thjuly #independenceday
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New Whitepaper Alert! We’re thrilled to share our latest whitepaper on Analyzing therapeutic monoclonal antibodies using a platform size exclusion-HPLC method. This innovative approach highlights: 🔬 Rigorous validation of the SE-HPLC method 🔬 Robustness and reproducibility in results 🔬 Effective separation of size variants in mAbs Authored by: Haley Sutton, Hong Truong, Xuemei Han, Rachel A. Ronci, Falguni Patel, and Navin Rauniyar Discover how this method enhances the quality control of biotherapeutics. Read more: https://lnkd.in/ej4H5mxh #Biopharma #MonoclonalAntibodies #HPLC #Research #Biotechnology #Pharma #HealthcareInnovation #TanvexBioPharma
Analysis of Therapeutic Monoclonal Antibodies Using a Platform Size Exclusion-HPLC Method
chromatographyonline.com