American Pharmaceutical News In Review

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June 26, 2020

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Why Extractables and Leachables Matter

Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy. When that balance is disturbed by issues such as product adulteration, the damage to patients, revenues and corporate reputation can be substantial. That is why many pharmaceutical companies are paying increasing attention to testing requirements for extractables and leachables. Learn how the risks of unintended chemical changes could compromise product integrity either during the manufacturing process or on the shelf.

	Industry News

FDA Warns Certain COVID-19 Serology/Antibody Tests Should Not Be Used
The FDA recommends that clinical laboratories and health care providers stop using COVID-19 antibody... read more »

PTC Announces the Phase 2/3 Clinical Trial to Evaluate PTC299 for COVID-19
PTC announced the FDA has authorized the initiation of a trial to investigate PTC299 as a potential ... read more »

FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic
The FDA has issued warning letters to four companies for selling unapproved injectable drug products... read more »

Sagimet Announces Positive Results in NASH Trial of FASN Inhibitor TVB-2640
Sagimet Biosciences announced positive results from trial of FASN inhibitor TVB-2640 as a potential ... read more »

FDA Grants Accelerated Approval Metastatic Small Cell Lung Cancer Treatment
The FDA has granted accelerated approval to lurbinectedin for adult patients with metastatic small ... read more »

CLEW Receives EUA for Predictive Analytics Platform
CLEW announced the FDA has issued EUA for the company's ICU solution. read more »

	Featured Articles

AdvantaPure® Molded Assemblies for Final Filling In single-use design and implementation, integrity and robustness of the system are critically ... read more »

QC Corner: Upholding Biosafety Standards Despite the Acute Need for a SARS-CoV-2 Vaccine Viral vaccines were the first pharmaceuticals manufactured using living cells, revolutionizing the ... read more »

	Featured Announcements

Sievers Eclipse BET Platform: A Closer Look at Efficiency Gains, Comparability, and Analytical Results
Webinar
In this webinar, attendees will receive an introduction to the groundbreaking Sievers Eclipse BET ... read more »

	Featured Infographic

Top 5 Secrets to a Successful Cleaning Validation Program
Top 5 Secrets to a Successful Cleaning Validation Program
Here are five ways to ensure a successful and compliant cleaning validation program. read more »

	Featured Video

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 »

On-Demand Webinar: Identifying & Mitigating Errors in Organic Extractables & Leachables Screening
In this webinar, you'll learn the risks of omission, inexact identification, and inaccurate and imprecise quantitation in chromatographic screening ... watch »

	Featured Products

MB3000-PH FT-IR Analyzer
read more »

CELPHERE MCC Spherical Seed Core
read more »

	Featured Whitepaper

The Influence of Matrix Plasticity on Lubricant Effects
Tablet hardness is essential when formulating a solid dosage form. Certain combinations of commonly used excipients may lead to softer tablets. This study outlines how to avoid those pitfalls and ... read more »

Tabletability: Compactibility and Compressibility: What’s the difference?
The science behind compressing a block of particles or granules into a single tablet can be complicated. But compression studies can tell you everything you need to know about compressing a ... read more »

	Events

Amorphous Solid Dispersions by Spray Drying from Bench to Market
Online – 06/30/2020
In this webinar we will provide an overview of the challenges and opportunities in developing amorphous spray dried dispersions (SDDs) from bench to ... event details »

6th Annual QC Micro Summit
Francis Marion Hotel – 09/14/2020
It’s an event that’s aimed to let you step away from the bench, learn about the big trends impacting our industry, share great ideas, and develop new ... event details »

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