American Pharmaceutical News In Review

View online

Forward to a friend | Facebook | Twitter

November 26, 2020

Newsletter Sponsor

Webinar: In-depth Understanding of API’s Behavior

Join us December 16th as Dr. Natalia Dadivanyan, Field Application Scientist for Malvern Panalytical, goes into depth about solid form analysis. This plays a vital role in material’s characterization throughout the whole pharmaceutical development cycle. Setting meaningful and realistic specifications for pharmaceutical product Critical Material Attributes (CMAs) is an important step in ensuring a product meets its target performance profile.

	Industry News

J&J, HHS Expand Agreement to Support Next Phase of COVID-19 Vaccine Development
Johnson & Johnson announced the expansion to the partnership between Janssen and the BARDA for the ... read more »

BioAegis Expands COVID-19 Treatment Clinical Trial in EU for Inflammation Regulator
BioAegis Therapeutics has expanded its clinical trial in severe COVID-19 to additional sites in ... read more »

Biological E. Limited Starts Trial of its COVID-19 Vaccine Candidate
BE, Dynavax, and Baylor College announced BE has initiated a trial of its COVID-19 subunit vaccine ... read more »

Agios Announces Orphan Drug Designation for Sickle Cell Disease Treatment
Agios announced the FDA has granted orphan drug designation to the company’s first-in-class PKR ... read more »

FDA Grants Accelerated Approval to Pembrolizumab for Triple Negative Breast Cancer
The FDA has granted accelerated approval to pembrolizumab in combination with chemotherapy for ... read more »

Apellis Announces NDA Priority Review PNH Treatment
Apellis announced the FDA has accepted and granted Priority Review designation for the NDA for ... read more »

	QC Corner

QC Corner: Single-Use Systems Underline the Rising Significance of Extractables and Leachables Studies
Examining extractables and leachables is an important safety issue as these substances can adversely... read more »

A Roadmap for Implementing QRM Principles in Drug Substance Manufacturing
The ICH Q7 good manufacturing practice (GMP) guidance for active pharmaceutical ingredients (API) ... read more »

	Infographic

Science of Scale for Spray-Dried Intermediates
Effective technology scaling requires in-depth knowledge of problem statements, process parameters, tools, and equipment. Lonza scientists and ... read more »

	Featured Articles

Scaling Autologous T-Cell Therapy Manufacturing Cell Therapy, including engineered T-cells, is becoming a more familiar feature in the medical world, especially as a treatment option for patients ... read more »

Examining Claims Accepted as Fact in LAL and rFC Comparison Studies Given the recent successes of recombinant Factor C, there has been an increase in commercial supplier comparison studies for recombinant Factor C (rFC... read more »

	Featured Video

On-Demand Webinar: Development and Validation of a Duplex qPCR assay for the Detection of Residual Sf9 Host Cell DNA and Baculovirus DNA
In this webinar, you will learn more about current regulatory requirements for residual host DNA clearance for biological products and what that means... watch »

On-Demand Webinar: Introducing the Latest Technology in Bioburden Testing
In this webinar you’ll learn about the improvements made to reduce the chance of cross contamination, improvements made to assist with traceability, ... watch »

	Featured Products

NanoRam Handheld Raman Spectrometer
read more »

Soluplus
read more »

	Featured Whitepaper

A Green Solution for the Dissolution Laboratory
Going “Green” in today’s business climate where maximizing shareholder equity and conserving capital is a top priority can be difficult, especially if the project increases the overall cost of doing ... read more »

R&D to Product: How to reduce costly scale-up problems
When scaling a new drug formuation. read more »

	Events

Microbial Identification for All: Exploring the MicroSEQ ID Microbial Identification System
Online – 12/09/2020
The MicroSEQ ID System is based on sequence analysis of ribosomal genes in bacteria and fungi. event details »

Excipient World 2021
National Harbor, MD – 09/27/2021
Excipient World is the leading education, networking and sourcing resource for the $6+ billion and growing global excipient market. It’s the ONLY U.S.... 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
164 Townsend St. Unit 2
San Francisco, CA 94107 USA