Pharmaceutical Technology ePT Weekly
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PharmTech
April 28, 2016
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in this issue

WHO Releases Report on Eliminating Malaria
Shire Builds Biologics Manufacturing Campus
FDA Releases Guidance on Immunogenicity Testing

Top Stories

NIH Study Identifies Better Parameter to Predict Flu Vaccine Effectiveness

Traditional methods of measuring the effectiveness of vaccines against the flu are called into question by new findings from the NIH.
/ read more /


Sanofi Invests €300 Million in Biologics Manufacturing Facility

Sanofi will invest in its Geel, Belgium facility in order to support its pipeline of monoclonal antibodies.
/ read more /


WHO Releases Report on Eliminating Malaria

WHO report highlights goal of eliminating malaria in 35 countries by 2030.
/ read more /

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SHARE YOUR KNOWLEDGE

PharmTech seeks objective, technical articles and papers from the bio/pharma community.

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Highlights from INTERPHEX 2016

MilliporeSigma Introduces Multi-Use Disposable Sterile

The company announced the launch of its first-in-class Lynx CDR connectors at INTERPHEX 2016.
/ read more /

Videojet Launches New Solvent Ink

The ink has a fast dry time, making it suitable for pharmaceutical packaging and labeling.
/ read more /

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PTI Inspection Introduces New Blister Packaging Technology

The VeriPac UBV Leak Detection System is designed specifically for multi-cavity blister packs.
/ read more /

Bioanalyte Analyzer Shortens Measuring Time

Beckman Coulter Life Science's new Vi-Cell Metaflex is designed to be operational for more than 22 hours a day.
/ read more /


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Industry News

Fresenius Kabi Recalls Sensorcaine-MPF Injection, USP

The company voluntarily recalls product due to particulate matter.
/ read more /


NIH Suspends Research in Sterile Production Facilities

NIH decided to suspend research after the facilities were found not in compliance with CGMP practices.
/ read more /


More Industry News

Supplier News

Walker Barrier Systems Products to be Rebranded as Extract Technology

Extract Technology's portfolio will now include aseptic solutions, containment solutions, restricted access barriers, and mobile cleanrooms for the pharmaceutical, healthcare, biotech and chemical markets.
/ read more /


Tablet Coating Reduces Production Times

The Opadry QX from Colorcon is suitable for tablets containing temperature-sensitive active ingredients.
/ read more /


More Supplier News
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Natoli Engineering's Basics of Tablet Manufacturing & Troubleshooting course, June 14-16, is designed specifically for tablet compression industry professionals. Who will benefit?: Tooling technicians, tablet press operators, tablet press maintenance technicians, QC/QA personnel, research and development, and their supervisors. Through a series of lectures and hands-on workshops led by top industry experts, attendees will learn firsthand how to minimize downtime by troubleshooting compression problems.
Sign up TODAY!.


Bio/Pharma News

Shire Builds Biologics Manufacturing Campus in Ireland

Linker technology and drug combinations play an important role in the efficacy of ADCs.
/ read more /


GSK Opens New Respiratory Manufacturing Facility

The facility located in Ware, UK, will be used to manufacture GSK's Ellipta inhaler.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Releases Guidance on Immunogenicity Testing of Therapeutic Proteins

The agency publishes draft guidance on assay development and validation for immunogenicity testing.
/ read more /


PRAC to Review Canagliflozin and Direct-Acting Antivirals

PRAC said it has plans to review both canagliflozin and several direct-acting antivirals, after new study data showed potential risks associated with the drugs.
/ read more /


More Regulatory News

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The largest, most influential biotech Convention in the world is coming to San Francisco, June 6-9, 2016. Experience powerful business partnering, benefit from invaluable education sessions and network with 15,000+ of biotech's best and brightest. See how the everyday becomes extraordinary — at BIO 2016.
Register now at convention.bio.org.


FEATURED TOPICS

FORMULATION

Headspace Moisture Analysis for Determination of Residual Moisture Content in Lyophilized Pharmaceutical Products

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.
/ read more /

 

PACKAGING

Blister Pack Optimization

Science-based software and testing services expedite the material selection process and ensure blister packs deliver adequate barrier protection for solid-dosage forms without over-packaging.
/ read more /


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Celebrate 40 years of processing innovations at America's largest powder event, International Powder & Bulk Solids Conference & Exhibition! Source solutions from hundreds of industry suppliers and network with thousands of industry peers from top companies, including Dow Chemical, PepsiCo, and Jenike & Johanson. Get into the minds of leading processing experts with unparalleled technical training designed to advance your career at the world-class conference. Learn more.


OUTSOURCING

More Outsourcing? More Monitoring.

A global API marketplace increases the burden of supply chain monitoring for drug companies.
/ read more /

QUALITY

Failure Mode Effects Analysis for Filter Integrity Testing

Understanding of the risks associated with FMEA is crucial in lot release testing.
/ read more /

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Cost Effective Solutions to Develop and Manufacture Product
INTERPHEX is a premier pharma, bio and medical device development and manufacturing event dedicated to Innovation, Technologies and Knowledge throughout the full product development life cycle. Join us in New York, April 26-29, 2016. Register for your complimentary Technical Education and Exhibit Hall Pass Today at
www.INTERPHEX.com/Register. Discover what's NEW at #INTERPHEX.


REGULATIONS

FDA and Manufacturers Seek Safer Pain Medications

The campaign against opioid abuse opens door to more innovative therapies.
/ read more /

TECH TRANSFER

Requirements for Product Technology Transfer

Susan Schniepp, distinguished fellow, and Andrew Harrison, chief regulatory affairs officer and general counsel, both of Regulatory Compliance Associates, discuss requirements for successful product technology transfer.
/ read more /

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Employing a Lean Lab Approach to Optimize Lab Processes:
Part 1: Work Smarter Not Harder

On Demand
Learn more.


Webcasts

Monoclonal Antibody Purification by Protein A Affinity and Hydroxyapatite Mixed Mode: Multi-Column Continuous Chromatography

On Demand
Join Tosoh Bioscience and Semba Biosciences for a discussion on the use of high capacity protein A and hydroxyapatite resins for mAb purification using a multi-column continuous chromatography process.
Sponsored by Tosoh Bioscience


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The Top 4 Most Expensive Encapsulation Mistakes and How to Avoid Them
On Demand
Learn more


Addressing Formulation Needs With a Different Technology: Say “Hello” to Ion Exchange Resins

On Demand
Ion exchange resins have long been in the formulator's toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.
Sponsored by Dow

more webcasts


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Ensuring Effective Drug Stability Studies
Drug Stability Testing from Development to Shipping

On Demand
Learn more


on pharmtech tv

PharmTech TV

Building Biopharmaceutical Manufacturing Processes

Resolving Drug Shortages

Working with CMOs and CDMOs

Events

Global Drug Delivery and Formulation Summit

May 23-25, 2016

Quality Manufacturing Conference

June 6-8, 2016

BIO International Convention

June 6-9, 2016


more events

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Continuous Manufacturing of Pharmaceuticals: Scale-up of a Hot Melt Extrusion Process
On Demand
Learn more


REFERENCE BOOKS

Pharmaceutical Technology Outsourcing Guide

Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
/ Click here /

More Reference Library

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How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”
On Demand
Learn more


eBOOKS

2016 Solid Dosage Drug Development and Manufacturing eBook

New materials, instruments, and processes are facilitating solid-dosage drug formulation and manufacturing. This ebook reviews methods to address quality issues for APIs, excipients, and intermediates; analysis methods for elemental impurities and continuous powder processing; modeling tools to improve workflows, and methods to improve tablet compression.

more ebooks

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