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October 03, 2023

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CMC Testing Case Study
e-Book: Demonstrating Value Throughout the Bio/Pharma Product Development Lifecycle

Read our recent case studies to see how SGS is adding value to the pharmaceutical and biopharmaceutical drug development process and solving some of the most complex analytical challenges our clients face, including:

Achieving timelines for IND Filing for an mRNA-based program
Resolving cell-based assay challenges for three mRNA products
Completion of full-scope release testing for a high volume of finished product tablets under a condensed timeline
Navigating a complex regulatory filing to avoid delays.

	Industry News

Enable Injections Receives First FDA Approval
Enable Injections announced that the FDA approved the EMPAVELI Injector (enFuse®) for the ... read more »

NRx Pharmaceuticals Announces FDA Permission to Proceed on IND App for NRX-101 to Treat Chronic Pain
NRx Pharmaceuticals, a clinical-stage biopharmaceutical company, announced that FDA has given the ... read more »

Avenge Bio Receives FDA Fast Track Designation for AVB-001, a Novel Cell Therapy Leveraging the LOCOcyte™ Immunotherapy Platform
Avenge Bio, a biotechnology company developing the LOCOcyte™ Immunotherapy platform for the ... read more »

Adalimumab-adbm, Boehringer Ingelheim's Interchangeable Biosimilar to Humira®, Now Available at Low Wholesale Acquisition Cost
Boehringer Ingelheim announced that Adalimumab-adbm injection, the company's interchangeable* ... read more »

	Infographic

Strategies for Overcoming Challenges in Cell and Gene Therapy Manufacturing
This infographic covers seven challenges facing cell and gene therapy manufacturers and details the solutions that electronic batch recording can ... read more »

	Featured Articles

		Designing an Environmental Monitoring Solution for GMP Applications With the release of the new EU GMP Annex 1 revision, a review of current practices is required to ensure that the installed monitoring system, chosen ... read more »

		Process Validation and Sterility Assurance: Relations and Requirements The purpose of the production and process control subsystem (including sterilization process controls) is to manufacture products that meet ... read more »

	Featured Video

On-Demand Webinar: Detecting Contaminants, Ensuring Safety: A Closer Look at Our New High-Performance Mycoplasma Testing Solution
In this webinar, hear from Sharon Rouw, Senior Product Manager at Thermo, as she discusses discuss the benefits and performance characteristics of ... watch »

On-Demand Webinar: The Ultimate Guide to Fluid Transfer Systems: From Selection to Maintenance
Fluid transfer is vital across industries, but it comes with challenges like material selection, kinking, and contamination. Join us to master these, ... watch »

	Featured Products

Nexera Prep HPLC
Shimadzu Scientific Instruments The most important aspects of separation and purification are purity results, preparative processing... learn more »

AIRsight Infrared/Raman Microscope
Shimadzu Scientific Instruments Shimadzu’s one-of-a-kind AIRsight™ Infrared/Raman Microscope delivers more accurate results and ... learn more »

Pearlitol 200GT
Barentz PEARLITOL® 200 GT mannitol is a direct compression excipient, specially designed to reduce capping ... learn more »

	Featured Whitepaper

eBook: Enhancing Impurity Control with Data Management
Pharmaceutical development teams must demonstrate a comprehensive understanding of impurities found in their medication. This requires high-quality data, but handling the necessary information is a ... read more »

Datasheet: CHO Media and Feed Portfolio from Sartorius
Sartorius’ CHO media portfolio was developed for the cultivation of Chinese Hamster Ovary (CHO) and other mammalian cell lines. CHO Cells can be used for both stable and transient expression of ... read more »

	More Products

Portability Raman Analyzer Learn More
Central Chiller Systems for Manufacturing Learn More
BIOne 1250 Bioprocess Control Station Learn More

	Directory Categories

Cell Culture Kits Search More

Drug Delivery Search More

Pharmaceutical Excipients Search More

	Events

AAPS PharmSci 360
Orlando, FL – 10/22/2023
PharmSci 360 delivers research from across the pharmaceutical continuum, from discovery to delivery, and all stages in between. Thousands of ... event details »

Eastern Analytical Symposium 2023
Plainsboro, NJ – 11/13/2023
Each year the Eastern Analytical Symposium honors Analytical Chemists who have distinguished career achievements. event details »

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