Pharmaceutical Technology ePT Weekly
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PharmTech
November 10, 2016
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In this issue

New Protein May Lead to Better Drugs

Merck KGaA Invests in China

AI Firm Collaborates with Janssen

Top Stories

US Election Puts Health Policy in Play

What's ahead for the healthcare and pharmaceutical industries?
/ read more /


FDA Advises Limited Clinical Testing for Biosimilars

The biosimilar pathway permits licensure based on less than full clinical data.
/ read more /


UPS to Acquire Marken

UPS entered into a definitive purchase agreement to acquire Marken, a provider of supply-chain solutions for the life-science industry.
/ read more /

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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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Industry News

Newly Discovered Protein May Hold Key to Better Drugs for Neglected Diseases

Researchers in the University of Dundee have discovered a new method of activating drugs to combat visceral leishmaniasis. The discovery could lead to better treatments for neglected tropical diseases.
/ read more /


USP and Chinese Pharmacopeia Extend Partnership

US and Chinese pharmacopeial standards groups commit to collaboration on standards for drug safety.
/ read more /


More Industry News
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The 2016 PDA Data Integrity Workshop, Dec. 7-8, in San Diego, CA, will explore the multiple facets of data integrity, such as quality culture, human behavior, training needs and technology requirements. Through case studies, presentations and breakout sessions, this interactive, must-attend event will help you learn implementable, best practices for preventing, detecting, mitigating and remediating data integrity issues.
Learn more


Supplier News

Honeywell Launches Needle Stick-Resistant Gloves

Honeywell has launched a new range of gloves, Picguard Urban, which offers protection against needle stick and puncture.
/ read more /


Merck KGaA Invests in Pharma Production in China

The company invested more than €250 in production in China.
/ read more /


More Supplier News

Bio/Pharma News

ARTES and BioSun Collaborate on HPV Vaccine

German biotech ARTES and Iranian biopharma manufacturer BioSun will develop an HPV vaccine.
/ read more /


British Artificial Intelligence Firm Seals Drug-Development Deal with Janssen

British artificial intelligence company BenevolentAI has signed an exclusive license for a series of novel clinical-stage drug candidates with Johnson & Johnson.
/ read more /


More Bio/Pharma News


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Reducing Recall Risk in the Life Sciences
Recalls are an unfortunate reality in the Life Science industry. They can cost organizations a large amount of time and money, as well as negatively impact brand image and customer trust. In this white paper learn about best practices of Risk Management and how the use of Risk Management tools can decrease recall risk in the Life Sciences. Learn more


Regulatory News

China Facility Limits FDA Inspection

FDA puts Beijing Taiyang Pharmaceutical Industry Co. on import alert after company refuses access to inspectors.
/ read more /

 

NICE Recommends Eribulin

NICE recommended eribulin for the treatment of patients with breast cancer, reversing its 2012 decision.
/ read more /


More Regulatory News



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Need a cost-effective but world-class tablet press? Make the NP-155 your #1 choice! This economical workhorse is built to last with direct-drive gears for greater reliability. With a hardened steel die table, 3-point gravity feed frame, and touch-screen HMI control, this machine is a fantastic mix of precision and beauty. Capable of more than 280,000 tablets per hour. Read more on the NP-155 now!

FEATURED TOPICS

DRUG DEVELOPMENT

What Price Healing?

Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.
/ read more /

METHOD DEVELOPMENT

Application of QbD and QRM to Analytical Method Validation

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.
/ read more /


QUALITY

Cleaning Validation in Continuous Manufacturing

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.
/ read more /

MANUFACTURING

Lubrication in Continuous Tubular Powder Blenders

Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.
/ read more /


AAPS Exhibitor Guide

ICDD

ICDD's material identification databases are designed for rapid materials identification and interfaced with diffractometers and data analysis systems of the world's leading software developers and manufacturers of X-ray equipment.
AAPS Booth # 1320
/ Learn more /

Patheon

Patheon is a leading global provider of pharmaceutical development and manufacturing services with approximately 8000 employees across 26 locations worldwide.
AAPS Booth # 1609
/ Learn more /

Pfizer CentreOne

Pfizer CentreOne™ is a global CMO that focuses on API synthesis and sterile injectables fill-finish.
AAPS Booth # 434
/ Learn more /

Unither

Unither is a global development and manufacturing partner for proprietary and generic pharmaceutical dosage forms.
AAPS Booth # 1562
/ Learn 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


Get to Clinic Faster: Navigating Complex Biologics through Development and Manufacturing
Live Webinar: Wednesday, November 16 at 1:00pm EST
Register now


Simple Steps to Speed Encapsulated Drug Development
Live Webinar: Thursday, November 10 at 11:00am EST
Register now


ON DEMAND WEBCASTS

Risk Management Strategies for Quality Management in the Pharmaceutical Industry
On Demand
Learn more


Biocompatibility Testing of Combination Devices – New Regulatory Guidance
On Demand
Learn more


Reversed Phase Liquid Chromatography using Surrogate/Additional Stationary Phases
On Demand
Learn more


A Wireless Approach to Monitoring Systems in Complex, Regulated Environments
On Demand
Learn more


Strategies for IND Filing Success
On Demand
Learn more


Implementing On-Dose Anticounterfeiting Technologies for Solid-Dose Drug Products
On Demand
Learn more


Don't Let Your Diluent be the Weakest Link in Your Drug Product
On Demand
Learn more


Employing a Lean Lab Approach to Optimize Lab Processes: Part 2 “Improve Productivity”
On Demand
Learn more


Events

AAPS Annual Meeting and Exposition

November 13–17, 2016

Pharma Blockchain Bootcamp

November 16, 2016

2016 PDA Data Integrity Workshop

December 7–8, 2016

more events

REFERENCE BOOKS

Pharmaceutical Technology Drug Delivery Guides

A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects. Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery.
/ 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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