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October 06, 2020

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	Industry News

Covis to Acquire AMAG Pharmaceuticals
Covis will acquire AMAG for $13.75 per share in cash, or approximately $498 million on a fully ... read more »

Enlivex Reports Positive Allocetra Trial Results in COVID-19 Patients
Enlivex has reported positive top-line results of an investigator-initiated clinical trial of ... read more »

FDA Grants Fast Track Status to Dystrophic Epidermolysis Bullosa Treatment
Aegle announced the FDA has granted Fast Track designation to AGLE-102 for dystrophic epidermolysis ... read more »

Windtree Announces First Patient Dosed in Istaroxime Study
Windtree Therapeutics has dosed the first patient in its Phase 2 study of istaroxime in patients ... read more »

Provention Bio Files Clinical Module for Teplizumab
Provention Bio announced the submission of the clinical module of the Company's BLA to the FDA for ... read more »

FDA Announces Draft Guidance on Physiologically Based Pharmacokinetic Analyses
The FDA has announced the availability of the draft guidance for industry, The Use of ... read more »

	Featured Articles

Microbiological Attributes, Specifications, and Risk Assessment of Culture-Based Therapeutic Products A major challenge with emerging heterogeneous, live culture-based products is setting consistent, risk-based microbial specifications to protect the ... read more »

Functional Challenges for Alternative Bacterial Endotoxins Tests Part 2: Comparability Part one of this three-part series examined the scientific basis for recombinant methods and the history and extensive studies utilized previously for... read more »

	Infographic

5 Ways to Optimize Water Monitoring
This collection of articles covers a number of key topics in pharmaceutical water analysis. read more »

	Featured Video

On-Demand Webinar: Analytical Sciences of Amorphous Solid Dispersions
In this webinar you’ll learn how to understand and characterize ASD physical stability, what the most suitable techniques are for ASD characterization... watch »

Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products
Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and ... watch »

	Featured Products

BioTrak® Real-Time Viable Particle Counter
read more »

Eshmuno® CMX Chromatography Resin
read more »

	Featured Whitepaper

Safe and Effective Aqueous Solutions for the Pharmaceutical Industry
The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation. Virtually any pharmaceutical manufacturing equipment — from tablet presses to stainless steel mixing tanks — can be cleaned to stringent critically clean criteria by aqueous cleaning. read more »

ebook: Aseptic Processing Trends and Technologies
eBook offers a variety of strategies to optimize you aseptic fill finish small batch manufacturing to take advantage of the growing market for small-batch biopharmaceuticals. read more »

	Events

Development and Validation of a Duplex qPCR assay for the Detection of Residual Sf9 Host Cell DNA and Baculovirus DNA
Online – 10/13/2020
Current regulatory authorities (WHO, EMA and US FDA) limited the accepted amounts of residual DNA in biological products making it extremely important... event details »

A Quality Perspective Roundtable Discussion on the Successes and Challenges of Making Changes to Pharma Workflow
Online – 10/15/2020
Join us in an interactive roundtable discussion with real-world pharmaceutical industry professionals. event details »

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