Pharmaceutical Technology ePT Weekly
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PharmTech
November 17, 2016
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In this issue

Broad Institute and IBM Collaborate

Sartorius Opens Bioanalytical Testing Lab

EMA Recommends Three Biosimilars

Top Stories

Roche Launches Immunotherapy Research Network

Roche launched imCORE, a global network of cancer immunotherapy centers of excellence.
/ read more /


AAPS Announces Nine Fellowships

Nine fellows recognized for research ranging from cancer treatment to improved vaccines.
/ read more /

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Industry News

Byrn Recognized for Work in Solid State Chemistry of Drugs

AAPS presents Dale E. Wurster award to Stephen Byrn for his work in the field of solid state chemistry.
/ read more /


Broad Institute and IBM Begin Cancer Drug Resistance Research

The Broad Institute and IBM Watson Health will collaborate on a $50 million project to study how cancers become resistant to therapies.
/ read more /


More Industry News

PODCAST

Jennifer Zieverink, senior director of marketing and alliance management at Aprecia, and Grant Brock, vice-president of engineering at Aprecia, spoke with Pharmaceutical Technology about the company's ZipDose Technology, which is a three-dimensional printing technology used to make solid-dosage drugs.

WATCH NOW

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Take charge of your tablet design with Natoli Engineering's TabletCAD. This free web-based software allows you to design shapes, derive punch tip force and total volume, generate drawing to share with colleagues and more! TabletCAD is a simple, cost-effective way for you to create tablets to your organization's specifications. Join the growing number of manufacturers who are designing their tablets in the cloud.
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Supplier News

Sartorius Stedim Biotech Opens Bioanalytical Testing Laboratory in Boston

The new Boston laboratory offers advanced analytical testing services.
/ read more /


EAG Laboratories Opens Dedicated ICP-MS Lab

Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.
/ read more /


More Supplier News

Bio/Pharma News

BMS Enters into License Agreement for NASH Drug

The agreement allows Bristol-Myers Squibb exclusive license to manufacture and commercialize Nitto Denko Corporation's NASH treatment.
/ read more /


Mucosis Starts Phase I Trial of Needle-Free Nasal-Spray RSV Vaccine

The study in 48 healthy adults will assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of the RSV vaccine, SynGem.
/ read more /


More Bio/Pharma News


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Guidelines and Regulations for cGMP Mapping
There are 5 different guiding and regulating agencies for cGMP mapping processes. This document summarizes the agencies and the specific articles that should govern your mapping project in warehouses, production facilities, rooms and chambers. Download the document (PDF file).


Regulatory News

EMA Recommends Approval of Three Biosimilars

The agency recommended nine drugs including treatments for diabetes, hepatitis B, and HIV.
/ read more /

 

Existing Drugs May Be Repurposed to Fight Drug-Resistant Bacteria

NIH researchers developed a test to identify existing drugs that might be able to combat drug-resistant bacteria.
/ read more /


More Regulatory News



FEATURED TOPICS

FORMULATION

Dissolution Testing

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.
/ read more /

PEER-REVIEWED RESEARCH

Impact of Quality by Design on Topical Product Excipient Suppliers, Part II: Reasonable Expectations

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.
/ read more /


DRUG DELIVERY

Advances in Delivering Protein and Peptide Therapeutics

A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.
/ read more /

API SYNTHESIS & MANUFACTURING

“Rebirth” of Cocrystals?

FDA redefines cocrystals as APIs and not drug-product intermediates.
/ read more /


UPCOMING WEBCASTS

Advances in Manufacturing Technology Lead to Efficiency, Reliability, Flexibility and Speed to Market
Live Webinar: Tuesday, December 6 at 11:00am EST
Register now


ON DEMAND WEBCASTS

Get to Clinic Faster: Navigating Complex Biologics through Development and Manufacturing
On Demand
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Simple Steps to Speed Encapsulated Drug Development
On Demand
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Risk Management Strategies for Quality Management in the Pharmaceutical Industry
On Demand
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Biocompatibility Testing of Combination Devices – New Regulatory Guidance
On Demand
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Reversed Phase Liquid Chromatography using Surrogate/Additional Stationary Phases
On Demand
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A Wireless Approach to Monitoring Systems in Complex, Regulated Environments
On Demand
Learn more


Strategies for IND Filing Success
On Demand
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Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
On Demand
Learn more


Events

2016 PDA Data Integrity Workshop

December 7–8, 2016

Peptalk: The Protein Science Week

January 9–13, 2017

CPhI North America

May 16–18, 2017

more events

REFERENCE BOOKS

Pharmaceutical Technology Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
/ Click here /

More Reference Library

eBOOKS

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.


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