American Pharmaceutical News In Review

View online

Forward to a friend | Facebook | Twitter

August 06, 2020

Newsletter Sponsor

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 the pharmaceutical and medtech industries, along with their associated regulators, are paying increasing attention to testing requirements for extractables and leachables (E&L). Recent trends in product development and manufacturing have multiplied the risks of unintended chemical changes that could compromise product integrity either during the manufacturing process or on the shelf.

	Industry News

Direct Biologics Receives FDA Approval to Initiate “EXIT-COVID-19” Drug Trial
Direct Biologics has received approval from FDA that it may proceed with a Phase II trial under an ... read more »

Seqirus Begins Shipping 2020/21 Influenza Vaccines to U.S. Market
Seqirus has begun shipping its portfolio of seasonal influenza vaccines to customers in the U.S. for... read more »

COVID-19 DNA Vaccine Targeting SARS-CoV-2 Proven Effective in Non-Human Primates
INOVIO announced its COVID-19 DNA vaccine INO-4800 targeting SARS-CoV-2 was effective in protecting ... read more »

FDA Announces Availability of Final Guidance, Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
The last few decades have seen an increasing demand in various health care settings for solid oral ... read more »

AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention
AbbVie announced the Phase 3 trial evaluating atogepant met its primary endpoint of statistically ... read more »

Constant Therapeutics Announces Start of Phase 2 Trial of Peptide Drug TXA127 for COVID-19
Constant announced its peptide drug TXA127 will be tested in a Phase 2 clinical trial at Columbia ... read more »

	Featured Articles

A Viral Contamination Control Program – In the COVID-19 Era In recent months, the world has been dealing with an outbreak of a novel coronavirus, designated ... read more »

Evaluation of a Quaternary Ammonium Ready-to-Use (RTU) Disinfectant and Hydrogen Peroxide/Peracetic Ready to Use (RTU) Combination Sanitization Regimen for Cleanroom Start-Up A clinical supply manufacturer was adding a new integrated filling operation to its aseptic filling ... read more »

	Featured Infographic

Quality Control and Assurance Across Industries
Spectroscopy and Microscopy are used across industries in QC and QA applications. read more »

	Featured Video

On-Demand Webinar: Platform Purification Approaches for the Production of Complex Biologics
In this webinar we will discuss the attributes of Thermo Scientific POROS Ion Exchange and Hydrophobic Interaction chromatography resins, addressing ... watch »

Watch Video: Introducing the SKANFOG SPECTRA
Watch Video: Introducing the SKANFOG SPECTRA watch »

	Featured Products

CELPHERE MCC Spherical Seed Core
read more »

MB3000-PH FT-IR Analyzer
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 »

Understanding the Importance of Punch Length and Cup Depth
Consistently manufacturing tablets to a uniform hardness, weight, and thickness require punches of consistent lengths—but not all lengths of tablet compression tooling have the same importance. Know ... read more »

	Events

CPhI North America
Philadelphia, PA – 04/20/2021
Over the last three years, CPhI North America has brought together more than 15,000 industry professionals across the entire pharmaceutical supply ... event details »

Pre-filled Syringes San Francisco
Virtual – 09/14/2020
SMi is proud to announce the inaugural Prefilled Syringes San Francisco event taking place in September 2020. The global pre-filled syringes market... event details »

This information is being brought to you because you are a subscriber to
American Pharmaceutical Review. To ensure delivery to your inbox,
please add newsletters@americanpharmaceuticalreview.com to your address book.

Manage your Subscription | Unsubscribe | Contact American Pharmaceutical Review

American Pharmaceutical Review
395 Oyster Point Blvd, Suite 300
South San Francisco, CA 94080 USA