New on Pharma's Almanac: Tanvex CDMO's Xuemei Han, Ph.D., explains how successfully advancing biopharmaceutical drug candidates from early development to clinical trials and commercialization, particularly with accelerating development timelines, requires an in-depth consideration of analytical method development and validation needs. Dr. Xuemei Han is the Director of Analytical Development at Tanvex, leading a team of scientists that focuses on analytical development of biologics. She has over 15 years of experience in analytical development from both academia and biopharmaceutical industry and has contributed to CMC development and IND/BLA filings of multiple biosimilar products. #Biosimilars #Validation #AnalyticalMethodDevelopment
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Exciting developments in the Biologics CDMO Market! The latest report on the biologics CDMO market reveals some intriguing trends and opportunities. With the growing demand for innovative biologics and the increasing complexity of drug development, CDMOs are playing a crucial role in accelerating time-to-market and enhancing production capabilities. Key highlights: - Market Growth: The biologics CDMO market is on the rise, driven by advances in technology and a robust pipeline of biologic therapies. - Innovation: Emphasis on high-quality production and efficient processes is paving the way for more groundbreaking treatments. - Opportunities: Emerging markets and technological advancements present significant opportunities for CDMOs to expand their reach and impact. #Biologics #CDMO #Pharma #Biotech
Biologics CDMO Market
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Aurigene Opens #Biologics Facility Offers Process Development and Clinical Scale Manufacturing Capabilities Aurigene Pharmaceutical Services Limited (Aurigene), a Dr. Reddy's Laboratories company, inaugurated its biologics facility spread across 6500 m2 (70,000 sq ft) in Hyderabad, #India. The facility is designed to serve customers with process & analytical development and small-scale manufacturing of #antibodies and other recombinant proteins for preclinical and early-phase clinical requirements. The process and analytical development laboratories are now operational while the commissioning of manufacturing capacity will be completed later in 2024. The state-of-the-art facility is equipped with top-tier equipment and staff, enhancing its current discovery capabilities focused on complex proteins. This addition expands its end-to-end service offering, delivering solutions from discovery to large-scale commercial manufacturing. The new Genome Valley facility will provide robust and compliant cell lines, process development solutions, and analytical methods, supporting customers’ rapid clinical development progression. This initiative is part of Aurigene’s strategy to support growth in both small molecule and biologics spaces, as shown by recent AI/ML-led drug discovery and a collaboration with Vipergen, a DNA-encoded library technologies service provider. Read more on #CMI online: https://lnkd.in/eSUYqrM7
Aurigene Opens Biologics Facility
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"2023 brought an increase in regulatory approvals for a wide range of therapies, hinting at market stabilization and biotech funding returning to historical levels in the near future. On the other hand, the demand for large-scale biologics manufacturing was very strong as companies de-risked their supply chain and looked for cost-effective and reliable solutions." Jean-Christophe Hyvert, President of Biologics at Lonza, shared his perspective on some of the key events in biopharma in 2023, and what regulatory changes to look out for in 2024. You can read about the key trends in 2023 in Pharma's Almanac here: https://lnkd.in/da3fd6kj And about the most important regulatory decisions in the future here: https://lnkd.in/g-yU58uV #AHealthierWorld #Biologics #PharmaceuticalManufacturing
What do you see as the most significant regulatory decision or guidance on the horizon for 2024 (or beyond)?
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Biopharmaceuticals or Biologics represent some of the best accomplishments of modern science. Particularly, biopharmaceuticals refer to pharmaceutical substances or drugs derived from biological sources. These drugs are increasingly being used in nearly all branches of medicine and have become one of the most effective clinical treatment modalities for a broad range of diseases, including cancers and metabolic disorders. In our latest article, authors Manisha Singh and VANEET KAUR delve into the challenges and opportunities in patenting biopharmaceuticals, highlighting key criteria, judicial interpretations, and the impact of various sections under the Indian Patents Act. To discover how global advancements and local regulations shape the future of healthcare innovation while ensuring affordability, read the full article first published by Lexology: https://lnkd.in/gAiMKFf3 #Patents #PatentLaw #PatentProtection #IntellectualProperty #Biopharmaceuticals #Biologics #Innovation #Healthcare #IndianPatents #Pharmaceuticals #Biotech #MedicalResearch #DrugDevelopment
Patenting Biopharmaceuticals in India
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Ready to unlock the secrets to analytical success in biologics development? 🔓 Biologic drug developers must consider adopting tactics and strategies to enable analytical success. But what are these tactics, and how can they shape the future of biopharma? Our blog post delves deep into the world of biologics analytical testing, exploring innovative strategies and practical approaches to ensuring success for your early phase clinical products. Curious to learn more? Read the full blog here. 👇 https://loom.ly/VN43vOE #Biologics #CDMO #AnalyticalTesting
Optimizing maintenance for equipment reliability
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Exciting news for the scientific community! A new optimized method is set to revolutionize the analysis of complex biologics. By streamlining processes and leveraging advanced techniques, this method promises to unlock deeper insights into these intricate molecules. Stay ahead of the game and keep up with the latest scientific advancements. #BiologicsAnalysis #OptimizedMethod #ScientificAdvancements #pharma #symmetrictrainings
Optimised method could facilitate analysis of complex biologics
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BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> Delivery systems for biologics - European Pharmaceutical Review >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #pharmaceutical #biotech #healthcare #competitivemarketing
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#FDA has released its long-awaited draft Platform Technology Designation Program for Drug Development: Guidance for Industry, which could represent a potentially significant shift in the regulatory and commercial strategies for novel drug and biologics products. Our alert looks at the key details. #DrugDevelopment #PlatformTechnology #FDCA https://lnkd.in/dfqtb6GF
FDA issues Platform Technology Designation Program for Drug Development draft guidance | DLA Piper
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I am happy to share our another publication in progress in Molecular Biology and Translational Science (Elsevier) (Impact Factor =3.6) is now available online. #Repurposing of biologics #biopharmaceuticals #therapeutic
Repurposing of biologics and biopharmaceuticals
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