American Pharmaceutical News In Review

View online

Forward to a friend | Facebook | Twitter

July 25, 2024

Newsletter Sponsor

Now Available On-Demand: Extractables & Leachables Regulatory Expectations for Cell & Gene Therapy
Sponsored by Element Materials Technology

If you're a bioprocess engineer, regulatory affairs professional, QA/QC specialist, researcher or scientist, you won't want to miss this informative talk with leading experts! Learn more in this case study on PFAS identification utilizing E&L testing, addressing safety, regulatory feedback, and industry collaboration for safer therapy products.

	Industry News

FDA Issues Guidance on Manufacturing Changes to Biosimilars and Interchangeable Biosimilars
The FDA has issued a draft guidance, Postapproval Manufacturing Changes to Biosimilar and ... read more »

BeiGene Opens Flagship U.S. Biologics Manufacturing and Clinical R&D Facility
BeiGene, Ltd. announced the opening of its flagship U.S. facility in Hopewell, N.J., at the ... read more »

Currax Announces New Facility to Assures Continuity of Supply of Anti-Obesity Treatment CONTRAVE®/MYSIMBA® Amidst GLP-1 Supply Issues
Currax Pharmaceuticals LLC announced the approval of additional manufacturing site for CONTRAVE®/... read more »

Emmes Group Partners with Miimansa AI to Accelerate Adoption of Generative AI in Clinical Research
Emmes Group, a specialty tech-enabled global contract research organization (CRO), announced a multi... 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

Advances in Electroporation Technology: Cell & Gene Therapy Development Innovations from MaxCyte
Join Mike Auerbach, editor-in-chief at American Pharmaceutical Review and Debra Barberini, PhD, ... read more »

	Infographic

Exploring Oligos and Peptides for Pharma Manufacturing
This infographic details the features and benefits of AJIPHASE technologies. Download now to learn more. read more »

	Featured Articles

		Pharmaceutical Compressed Air and Compressed Gases: Microbial Quality Standards and Expectations Compressed gases are used at various steps of the pharmaceutical manufacturing process. Applications include weighing stations process line; use of ... read more »

		For U.S. Market Entry, Don’t Overlook Abbreviated Applications to FDA for Drugs, Biologics, and Devices The U.S. biopharma and medical device markets remain the largest and most robust in the world. The statistics on the size and potential growth of ... read more »

	Featured Video

Optimizing Lipid Nanoparticles (LNPs) Processing for siRNA Delivery by Microfluidics System
Optimizing lipid nanoparticles (LNPs) processing for siRNA delivery by microfluidics system watch »

Viral Safety for Biological Raw Materials
Need guidance on reducing contamination in your advanced therapy? Watch Dr. Kerstin Brack’s presentation, “Viral safety aspects of biological raw ... watch »

	Featured Products

BIOne Single-Use Fermentor
Distek, Inc. The BIOne Single-Use Fermentor (SUF) by Distek is ideal for numerous microbial fermentation ... learn more »

CHO-HCP ELISA Kit
Charles River Introducing the world’s first IgY based CHO-HCP ELISA kit specifically designed to close the ... learn more »

BRAND® accu-jet® S Pipette Controller
BRANDTECH® Scientific Brought to you by BRANDTECH® Scientific, the accu-jet® S pipette controller stands alone as ... learn more »

	Featured Whitepaper

Whitepaper: Disinfectant Efficacy in cGMP-Compliant Pharmaceutical Manufacturing Settings
The FDA’s intensified onsite inspections of drug production post-pandemic have underscored the importance of robust cleaning- and disinfectant-validation programs. This whitepaper focuses on the ... read more »

Poster: Oxygen Mass Transfer Characterization in a Single-Use Bioreactor using Response Surface Design of Experiment (DoE) Modeling
Achieving holistic process understanding is crucial for upstream process development, requiring models that describe the effects of input factors on culture health and productivity. Quality by Design ... read more »

	More Products

AdvaTab Orally Disintegrating Tablet Technology Learn More
BioTrak® Real-Time Viable Particle Counter Learn More
Cary Eclipse Fluorescence Spectrophotometer Learn More

	Directory Categories

Microbial Detection Kits Search More

Pharmaceutical Infrared Spectrometers Search More

Excipient Search Search More

	Events

PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024
Phoenix, AZ – 10/22/2024
Learn about groundbreaking innovation in injectable drug delivery at the 21st edition of this popular conference! The largest event on pre-filled ... event details »

PDA Pharmaceutical Microbiology Conference 2024
Washington, DC – 10/07/2024
Connect science and compliance at the 19th annual Pharmaceutical Microbiology Conference and navigate the crucial nexus between scientific advancement... event details »

This information is being brought to you because you are a subscriber to
American Pharmaceutical Review. To ensure delivery to your inbox,
please add newsletters@americanpharmaceuticalreview.com to your address book.

Manage your Subscription | Unsubscribe | Contact American Pharmaceutical Review

American Pharmaceutical Review
164 Townsend St. Unit 2
San Francisco, CA 94107 USA