"Analytical methodology requires specialized expertise, equipment, and methods to accommodate the unique molecular structures being employed in ADC manufacture, release, and stability testing." Read More about this in our blog "Antibody Drug Conjugates – Innovation and Challenges" by Robert Kelly. https://lnkd.in/esTvaTzE #Biologics #Biosimilars #RegulatoryAffairs #Innovation
Insightful
In this interview, Vikas Gupta, President of CDMO ReciBioPharm, outlines several key trends shaping the biopharma manufacturing landscape, including the rise of nucleic acid-based therapeutics, and the quest for continuous manufacturing. #biologics #biotherapeutics #RNAtherapies #PAT #continuousmanufacturing
In this interview, Vikas Gupta, President of CDMO ReciBioPharm, outlines several key trends shaping the biopharma manufacturing landscape, including the rise of nucleic acid-based therapeutics, and the quest for continuous manufacturing. #biologics #biotherapeutics #RNAtherapies #PAT #continuousmanufacturing
"The docket comments focused particular attention on the subsection on cellular starting material, regarding the prominence of recommendations for patients who may have received previous CAR T cell treatments. The draft guidance recommended testing of the leukapheresis product to evaluate the presence of prior CAR T cells and of the final drug product to determine the level of new and prior CAR T cells." #DahliaConsulting #BiopharmaceuticalIndustry #CommercialLifeSciences #ManagementConsultant #LifeSciencesBusinessStrategy #GlobalPharma #GlobalBioTech #SupplychainOperations #CommercialOperations #CGTcommercialization #Manufacturing #QualityAssurance #OperationalExcellence #FinancialAnalysis #OpModelDesign #LifeScience #BioTechnology #Bioprocessing #Biosimilars #BioPharmaIndustry #MedicalResearch #CDMO #GMP #GMPbatch #GMPmanufacturing #GenomeEditing #GeneTherapy #CellTherapy #Car_T #mRNA #cGMP #ClinicalGradeManufacturing #ClinicalGradeProduction #BiologicsLicenseApplication #BLA #Pharmaceuticals #RegenerativeMedicine #CellAndGene #FDA #Cber #VectorManufacturing #VectorTesting #ClinicalRecommendations #NonClinicalRecommendations #TreatmentPlan
In this interview, Vikas Gupta, President of CDMO ReciBioPharm, outlines several key trends shaping the biopharma manufacturing landscape, including the rise of nucleic acid-based therapeutics, and the quest for continuous manufacturing. #biologics #biotherapeutics #RNAtherapies #PAT #continuousmanufacturing
The specialty biologics industry has come a long way, and Genefic, a Dalrada subsidiary, is proud to be part of this evolution. Discover how advances in biotech are transforming modern medicine and making life-saving treatments more accessible. Read more: https://lnkd.in/egmEDu23 #Biologics #SpecialtyBiologics #Biotech #Pharmaceuticals #HealthcareInnovation #Biosimilars #MedicalBreakthroughs #Biotechnology #ChronicDiseaseTreatment #PrecisionMedicine #BiologicTherapies #ModernMedicine #Genetics #PatientCare #AutoimmuneDiseases #HealthcareTransformation #DrugDevelopment #AdvancedTreatments #PersonalizedMedicine
#Regulatory authorities are engaging stakeholders to shape guidelines that ensure the #safety and efficacy of innovative #mRNA therapies. In the meantime, sponsors rely on existing regulatory experiences. In this article, Minghua Liu discusses some of those interactions with regulators over the past two years. #biotechnology #pharmaceuticalindustry #celltherapy
BioPharma & HealthTech Competitive Strategy & Insights | Digital & AI Solutions | Gene & Cell Therapy | Vaccines
Thoughts on this? >> Genprex Receives Notice of Patent Grant for Korean Patent Claiming Reqorsa® Immunogene Therapy with PD-1 and ... - Yahoo Finance >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #pharma #competitivemarketing #healthcare #pharmaceutical
Thoughts on this? >> Genprex Receives Notice of Patent Grant for Korean Patent Claiming Reqorsa® Immunogene Therapy with PD-1 and ... - Yahoo Finance >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #healthcare #pharmaceutical #pharma #competitivemarketing
Are you prepared to meet the challenges of a rapidly evolving testing landscape for biological therapeutics? As the industry demands faster turnaround times for testing, regulatory agencies increasingly require more sophisticated analytical techniques. In this article, Element biologics expert Dr. Khanh Ngo Courtney helps you anticipate these changes to meet your timelines and gain regulatory approval. https://lnkd.in/gDMibMEX #ElementInPharmaceutical #biologics #drugdevelopment #proteomics #mycoplasma #rawmaterials #testing #analyticalservices #ThoughtLeadership #IndustryTrends
In 2019, FDA predicted that by 2025, it would approve 10 to 20 CGTs annually. Last year, seven CGTs were approved ( bringing the total to 35 approved to date.) Emily Marden and Kelly Cho provide a thoroughly referenced overview. #celltherapy #genetherapy #biologics #pharmaceuticalindustry
Pharmaceutical Consultant
1moVery informative.