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PharmTech Europe

25 August 2015

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Top Stories

Cracked Caps Spark Recall of Merck’s Cancer Drug Bottles

Citing failure to meet child-resistant closure requirement, Merck has advised that all bottles should be examined for cracks and that affected bottles should be kept out of children’s reach.
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Mylan Receives FDA Warning Letter for Manufacturing Sites in India

Mylan received an FDA warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.
/ read more /


Novo Nordisk Licenses Genmab's Bispecific Antibody Platform

Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments.
/ read more /

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FOCUS ON APIs

API Sourcing, Supply Chain Visibility, and Emerging Markets

Kate Kuhrt, senior director, Generics and Biotech, Thomson Reuters, shares insights on sourcing trends, supply chain challenges, the emerging market outlook, and how it affects European pharmaceutical manufacturers.
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Moving On to Implementation for Elemental Impurities Testing

After a long wait for the new elemental impurities guidelines, the bio/pharma industry must now look ahead to implementation and take action.
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MORE ON APIs

FOCUS ON EXCIPIENTS

Key Considerations in Excipients Selection for Solid Dosage Forms

Randy Wald, senior research fellow at Bend Research, part of Capsugel Dosage Form Solutions looks at advances in excipients and the impact on formulation development and manufacturing processes.
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A Case for Solid Dispersions

Experts from Dow Pharma & Food Solutions discuss the versatility of solid dispersions in solubility enhancement and the importance of pairing the API to the optimal polymer.
/ read more /


More on Excipients

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NEWS AND TRENDS

FDA Releases Guidance on Developing Botanical Drugs

FDA’s Center for Drug Evaluation and Research provides guidance on development plans for botanical drugs.
/ read more /

 

FDA Guidance on Treatments for Rare Diseases

The agency issued guidance regarding common issues involved with the development of treatments for rare diseases.
/ read more /


More News

FEATURED TOPICS

BIO/PHARMA NEWS

GSK Factory in Tianjin Affected by Explosion

GSK reports no employee injuries at the facility and is assessing damage.
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INDUSTRY NEWS

Continued Process Verification Key to Lifecycle Control and Continuous Improvement

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.
/ read more /

SUPPLIER NEWS

Hermes Pharma Expands Formulation Services to US Market

Companies in the US will now have the opportunity to tap into Hermes Pharma’s expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules.
/ read more /

BIOLOGICS

Cell Culture, Single Use, and the Evolving Biopharmaceutical Landscape

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.
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SUPPLY CHAIN

Multiple Partners, One Supply Chain

Cloud computing has made it easier for pharma companies and their contract partners to gain visibility into their combined supply chains.
/ read more /

FORMULATION

Black Specks in Tablet Stability Samples

A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.
/ read more /


Webcasts

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


Stability Assessment for Shipment of API and Drug Products

Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
Sponsored by: Patheon


more webcasts

on pharmtech tv

PharmTech TV

Working with CMOs and CDMOs

FDA Comments on Continuous Manufacturing

Compliance and Technology for Track and Trace

Events

CPhI Korea 2015

7–9 September 2015 | Seoul, Korea

Particles in Parenterals—State-of-the-art visual inspection of sterile medicinal products

September 16-17, 2015 | Berlin, Germany


more events

REFERENCE LIBRARY

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

Solid Dosage and Excipients 2015 eBook

This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.


more ebooks
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