American Pharmaceutical News In Review

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November 27, 2024

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Ensuring Regulatory Compliance in Cell Therapies from Lab to Bedside

Bringing a new cell therapy treatment to market requires innovative and compliant solutions that can accelerate progress from the lab, all the way to the patient, safely and cost effectively. To streamline regulatory submission and smooth the transition from R&D toward manufacturing, it is crucial to maintain comprehensive and precise electronic records from the lab equipment used. Learn about solutions that can simplify 21 CFR Part 11 compliance in a cell therapy workflow in this video.

	Industry News

Valneva Submits Label Extension Application for its Chikungunya Vaccine to the FDA
Valneva SE has submitted a label extension application to the FDA to potentially extend the use of ... read more »

PTC Therapeutics Announces Results of CardinALS Trial of Utreloxastat in ALS Patients Missed Primary Endpoint
PTC Therapeutics, Inc. announced that the global Phase 2 placebo-controlled CardinALS study did not ... read more »

EC Approves TEVIMBRA for First-Line Treatment of Advanced/Metastatic Esophageal Squamous Cell Carcinoma and Gastric or Gastroesophageal Junction Cancer
BeiGene, Ltd. announced that the European Commission has approved TEVIMBRA® (tislelizumab) in ... read more »

Leukemia Drug Receives FDA Fast Track Designation
Lin BioScience announced that its lead pipeline, LBS-007, has been granted Fast Track Designation by... read more »

	QC Corner

Enhanced Cleanroom Control: Modern Methods for Accurate Mold Detection
In this webinar, hear from Dr. Doug Botkin from Charles River Laboratories as he discusses Enhanced ... read more »

	Cell and Gene Therapy Circuit

Next-Gen Sequencing in Cell and Gene Therapy Testing Services: Innovations from Eurofins BioPharma Product Testing
Learn how Eurofins is not only integrating NGS into its cell and gene therapy workflows, but also ... read more »

	Infographic

Revolutionizing Bioburden Testing
Download this infographic to learn ten benefits of the Sievers Soleil Rapid Bioburden Analyzer, including comprehensive monitoring, rapid time to ... read more »

	Featured Articles

		Lyophilization Technology for Improving Stability of Small and Large Molecules The instability of drugs constitutes a major barrier in the commercial development and manufacture of pharmaceutical products. Lyophilization, or ... read more »

		Customized Antibodies – Vehicles for Therapeutic Success They measure only a few nanometers in size, and yet they are our bodies’ first defense line against intruders of all kinds: antibodies are an integral... read more »

	Featured Video

Lab Balances in QC Labs
Watch this video to learn more about the solutions offered by Sartorius that will help you achieve reliable and accurate results from your lab ... watch »

Co-Processed Excipients for Self-Emulsifying Drug Delivery Systems
Learn how a formulators can benefit from an emulsion preconcentrate kit, and about the advantages, physical characteristics, manufacturing process and... watch »

	Featured Products

Mini-Uniprep™ Syringeless filters
Cytiva Transform your HPLC and UHPLC sample preparation with our Mini-UniPrep™ syringeless filters. These ... learn more »

Cell-IQ MCO 170AICUVHL-PA Incubator
PHC PHCbi brand's Cell-IQ™ CO2 incubators with capacities of 5.8 and 8.1 cu.ft. incorporate a patented ... learn more »

BioTrak® Real-Time Viable Particle Counter
TSI Incorporated Isolators are designed to keep operators out and sterile product safe. Nevertheless, traditional ... learn more »

	Featured Whitepaper

Streamlining Environmental Monitoring: A CMO’s Success with 3P® ENTERPRISE
This case study explores Selkirk’s journey with 3P^® ENTERPRISE. Download now to learn how it will help Selkirk prioritize efficiency and data integrity within their environmental monitoring ... read more »

Compliance with Annex 1: Sterile Fill Finish for Early Phase Clinical Supplies
Stay up to date on Annex 1 requirements for sterile fill finish processes in early-phase clinical supplies. In this whitepaper, Joe Page, PH.D., President of Eurofins BioPharma Product Testing San ... read more »

	More Products

AccuSizer SIS Liquid Particle Counter System Learn More
Cary 3500 Compact UV-Vis Spectrophotometer Learn More
CTech™ SoloVPE® System Learn More

	Directory Categories

Excipient Search Search More

Pharmaceutical Bioreactors and Fermentors Search More

Pharmaceutical Infrared Spectrometers Search More

	Events

3rd Annual PAT & Real Time Quality Summit
Philadelphia, PA – 12/11/2024
With drug developers and manufacturers facing closer scrutiny on product quality than ever before, it’s time to make the most of evolving process ... event details »

4th mRNA Analytical Development & Quality Control Summit
Boston, Massachusetts – 02/25/2025
Excitement for mRNA therapeutics continues as RNA technologies are awarded the Nobel Prize for the second year running. Yet, despite optimized ... event details »

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