American Pharmaceutical News In Review

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March 17, 2021

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	Industry News

SeqOnce Announces AzureSeq RT-qPCR Assay to Detect SARS-CoV-2 E484K Variant of Concern
SeqOnce Biosciences announced the launch of AzureSeq One-Step Universal RT-qPCR kit for the ... read more »

CiRC Biosciences Announces Orphan Drug Designation for Retinitis Pigmentosa
CiRC announced the FDA has granted Orphan Drug Designation for CiPCs for the treatment of retinitis ... read more »

DemeRx Receives MHRA Approval for DMX-1002 Study for Opioid Use Disorder
DemeRx announced the company has approval from the MHRA to commence subject enrollment in a Phase 1/... read more »

PCR Biosystems Launches Advanced Bst Polymerase Reagents
PCR Biosystems have launched a range of IsoFast™ Bst Polymerase reagents for rapid, robust and ... read more »

Natera, Genentech Initiate Phase III Trial Using Signatera
Natera announced the first patient has been screened in a trial that uses Signatera as a companion ... read more »

IRICoR, Université de Montréal, IRIC and Valence Discovery to Design Parkinson's Disease Candidates
IRICoR and UdeM, the IRIC of the Université de Montréal, and Valence Discovery announced a ... read more »

	QC Corner

Analysis of FDA Enforcement Reports (2012-2019) to Determine the Microbial Diversity in Contaminated Non-Sterile and Sterile Drugs
An analysis of FDA enforcement reports from 2012 to 2019 showed that Gram-negative bacteria were the... read more »

Maintain Operational Efficiencies in Micro Lab During a Pandemic
COVID-19 has caused many micro labs to re-evaluate current processes. As such, this brief 15-minute ... read more »

	Featured Articles

Sample Sizing Approaches for Container Closure Integrity (CCI) Testing Sample size approaches for container closure integrity testing (CCIT) for routine commercial biopharmaceutical production vary across the industry. ... read more »

3D Printing in Personalized Drug Delivery Recently, the three-dimensional (3D) printing (3DP) process, often referred to as ‘additive manufacturing’, has gained significant attention across ... read more »

	Featured Video

On-Demand Webinar: Integrated Production Process of mRNA from E. coli to Highly Purified mRNA
In this webinar you’ll learn more about a new purification approach starting from E. Coli all through to mRNA production, resulting in improved ... watch »

On-Demand Webinar: Development Strategies for Expediting Time-to-Market of Spray Dried Amorphous Solid Dispersions
Key learning objectives in this webinar are linking process parameters to critical quality attributes and how to address them during development, ... watch »

	Featured Products

Parteck LUB STA 50 Vegetable Grade Stearic Acid 50
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Gemini HPLC Columns
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	Featured Whitepaper

White Paper: Validation Guidance for Residual Host Cell DNA Testing of Biologics
Assurance of product safety and quality are top of mind for all biotherapeutic manufacturers read more »

ebook: Lipid Excipients to Unlock Oral Bioavailability Issues
Oral dosage forms favor good patient acceptance and compliance in great part because they are easy to take. However, achieving sufficient bioavailability by the oral route can be challenging due to ... read more »

	Events

Commercializing Continuous Processing in Pharma 2021
Virtual – 03/23/2021
The 5th Commercializing Continuous Processing in Pharma 2021 will reunite the growing CCP community to discuss how to accelerate adoption of ... event details »

Use of the Andrew+ Robot and OneLab Automated Liquid Handling Platform for Bacterial Endotoxin Testing
Online – 03/25/2021
A bacterial endotoxin test (BET) is a requirement for any injectable drug or medical device to ensure safety. event details »

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