American Pharmaceutical News In Review

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October 06, 2022

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Contamination Control for Pharmaceutical Products

A program for contamination control should result in microbiologically acceptable product, typically containing a sterility claim. However, it is also critical that sterility can be demonstrated. Demonstration of sterility is usually accomplished by performing a sterility test via USP <71>, but such a test only represents one aspect of contamination control. Learn more.

	Industry News

FDA Launches Biosimilar Regulatory Science Program
Regulatory science research is an important component of the work the FDA does to facilitate the ... read more »

Astellas and Pantherna Collaborate on Research to Generate mRNA-Based Regenerative Medicine Programs
Astellas Pharma and Pantherna Therapeutics GmbH announced that the companies have entered into a ... read more »

Ginkgo Bioworks Acquires Circularis to Heighten Capacities in Cell and Gene Therapeutics
Ginkgo Bioworks made a tuck-in acquisition of Circularis, a biotechnology company with a proprietary... read more »

Alexion AstraZeneca Rare Disease Acquires LogicBio
LogicBio Therapeutics entered an agreement in which AstraZeneca Rare Disease acquired LogicBio. The ... read more »

	QC Corner

QC Corner: Regulatory Update: Rapid and Alternative Methods for ATMPs Webinar
In this on-demand webinar, Brice Chasey, Associate Director of Product Management at Charles River ... read more »

	Infographic

The Future of Bacterial Endotoxin Testing
Read Now!
Download this infographic for information and a table comparing the expected attributes from traditional LAL reagent, rFC, and rCR. read more »

	Featured Articles

		The Truth of Endotoxin Values - Points for Consideration During Investigation of Aberrant BET Results Bacterial Endotoxin Testing (BET) is mandatory for detection of Endotoxin/ Lipopolysaccharides (LPS) in parenteral drug products. This is important as... read more »

		Understanding Five Major Impacts of the Pandemic – and Future Implications for the Biopharmaceutical Industry The events of the past two years have made a profound impact on biopharmaceutical companies and every cog in the wheel of our industry. Internally, ... read more »

	Featured Video

On-Demand Webinar: High-Throughput and Wide-Range Protein Concentration Determination of Monoclonal Antibodies
In this webinar you’ll learn how to counteract the increasing risk of missing deadlines due to slow one-at-a-time quantification on large numbers of ... watch »

On-Demand Webinar: The Recombinant Factor C Assay, An Equivalent Alternative to LAL Assays
In this webinar, you’ll learn about: the history of the PyroGene® Recombinant Factor C Assay; the need for an alternative method; Recombinant Factor C... watch »

	Featured Products

EZ-Accu Shot™ Growth Promotion Test
Microbiologics Growth Promotion Testing of culture media can be a resource-consuming and tedious task. ... learn more »

Affinity Isothermal Titration Calorimeter
TA Instruments The Affinity ITC provides unmatched sample reproducibility with the highest sensitivity, innovative ... learn more »

PROSAT Sterile Wipes with CyQuanol
Contec, Inc. PROSAT® Sterile™ Wipes with CyQuanol™ (Meltblown Polypropylene) provide a consistent release of ... learn more »

	Featured Whitepaper

FDA 483s and Non-Compliance in Pharma
Download this white paper to learn more about FDA 483’s, drug production, compliance and QC. read more »

Whitepaper: Avicel® RC/CL: An Outstanding Excipient for Formulation Stability in Suspensions
Patient noncompliance contributes to 50% of all treatment failures and adds billions of dollars to healthcare costs worldwide.1 To address this gap, pharmaceutical manufacturers are increasingly ... read more »

	More Products

DSC-60 Plus Differential Scanning Calorimeter Learn More
Unisteri HP IL Compact Steam Sterilizers Learn More
EMPROVE® Extra Pure Sodium Sulfate Decahydrate Learn More

	Directory Categories

Pharmaceutical Chiller Systems Search More

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Pharmaceutical Excipients Search More

	Events

Webinar: Analysis of nitrosamines in drugs using chromatographic methods according to regulatory requirements.
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Join our live round-table discussion on October 6th, 2022. event details »

PDA Pharmaceutical Microbiology Conference
Washington, DC – 10/10/2022
The 2022 PDA Pharmaceutical Microbiology Conference continues the ongoing tradition of addressing the most relevant opportunities and challenges to ... event details »

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