Pharmaceutical Technology ePT Weekly
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PharmTech
May 21, 2015
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in this issue

Circassia Invests $377 Million
FDA Approves First Spray-Dried Biologic
Transdermal Drug Delivery

Top Stories

Eagle Pharmaceuticals Wins Patent Approval

The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers. / read more /


Endo Acquires Par for $8.05 Billion

The Irish company Endo International announced that it would acquire Par Pharmaceutical for $8.05 billion.
/ read more /


NECC to Pay $200 Million

NECC will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.
/ read more /


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Industry News

International Neonatal Consortium Launched

The Critical Path Institute launched a consortium to help develop therapies for newborns.
/ read more /


Rx-360 Establishes Working Group in India

Supply chain consortium establishes a working group to address quality problems in India.
/ read more /

More Industry News

Supplier News

Circassia Invests $377 Million in Asthma Specialists

UK-based Circassia invests approximately $377 million on Aerocrine and Prosonix. / read more /


SAFC Expands Enhanced Manufacturing Capabilities

SAFC's new ADC wing in St. Louis will feature commercial-scale manufacture of ADCs.
/ read more /

More Supplier News
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Bio/Pharma News

Emergent Enters Agreement with ProMetic Life Sciences

Emergent gives ProMetic long-term access to its Winnipeg facility. / read more /


AstraZeneca Invests $285 Million in New Facility

AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.
/ read more /

More Bio/Pharma News

Regulatory News

FDA Approves First Spray-Dried Biologic

Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery. / read more /


FDA Advisory Panel Questions Clinical Meaningfulness of Vertex’s Cystic Fibrosis Drug Combo

FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement. / read more /

More Regulatory News
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FEATURED TOPICS

DEVELOPMENT

Pharma APIs: It’s Still a Small World

Stronger pipelines, the need for complex chemistries, and the rise of small- to mid-size innovators are driving demand for small-molecule APIs. / read more /

MANUFACTURING

Considering Continuous Crystallization

An integrated pilot plant tests heteronucleation and continuous crystallization. / read more /

QUALITY

Ensuring the Quality of Biologicals

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users. / read more /

ANALYTICS

Streamlining Raw Materials Testing

The rapid testing of biologic raw materials can lead to greater efficiency. / read more /

DOSAGE FORMS

Transdermal Drug Delivery Gains Traction

Advances in transdermal drug delivery, particularly with microneedles, are enabling a wider range of drugs to be delivered through the skin.
/ read more /

OUTSOURCING

Biomanufacturing Outsourcing Globalization Continues

While the United States and Europe still dominate, CMOs and CROs based in emerging markets continue to capture market share.
/ read more /

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Building the future Using Simulation Effectively
Live Webcast: Wednesday, June 3 at 8:00 am PDT / 10:00 am CDT / 11:00 am EDT
Join our free webinar for a case study on the handling of complex manufacturing expansion projects, with insight on simulation and visualization tools, innovations for manufacturing of parenterals, effective team building, and more.
Register Free at www.pharmtech.com/pt/simulation


Webcasts

Solubility Enhancement: Solutions using Predictive Analytics & Molecular Modeling

Thursday, June 4, 2015 | 11:00 am EDT | 10:00 am CDT | 8:00 am PDT

Learn about a novel, systematic methodology to accelerate solubilization of poorly soluble molecules and speed formulation optimization and process development. Understand how molecular modeling can be used enhance the predictability of solubilization and overcome poor bioavailability.
Sponsored by: Patheon

Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Fragments

Wednesday, June 17, 2015, 2 pm EDT | 2 pm EDT | 11 am PDT

Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by: Tosoh Bioscience LLC

Preparing for the New Elemental Impurities Guidelines

On Demand

With the long anticipated revised guidelines for elemental impurities on the horizon, bio/pharmaceutical companies should initiate plans to transition to these new guidelines. In this webcast, experts (API, excipients and analytical testing) will discuss risk assessment, proposed test methods, and sample preparation techniques.
Sponsored by: SGS Life Science Services

more webcasts
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Controlling the Physical Properties and Performance of Semi-solid Formulations through Excipient Selection
Live Webinar: Wednesday, June 10, 2015 at 11am EST
Are you developing new topical products to meet specific design criteria? Are you seeking to replicate the performance of a reference product? In either case, you can achieve your goals by intelligently employing your toolkit of excipients and exploiting knowledge of how they work on a fundamental level. BASF will introduce you to cases that demonstrate the functionality of their excipients and their use in solving problems or meeting design objectives.
Register for free



Events

ISPE/FDA/PQRI Quality Manufacturing Conference

June 01-03, 2015 | Washington, DC USA

2015 AAPS National Biotechnology Conference

June 08-10, 2015 | San Francisco, CA USA

BIO International Convention 2015

June 15-18, 2015| Philadelphia, PA USA

more events
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The Importance of Data Integrity in a GXP Regulated Laboratory
Live Webcast: Wednesday May 27, 2015 at 11:00 EDT; 15:00 GMT; 16:00 BST; 17:00 CET
With increased inspection scrutiny on data integrity, it is critical that managers and scientists in GXP regulated laboratories understand the current regulatory position. Discover the criteria for data integrity and learn how to assess and improve laboratory data management processes to ensure compliance with current regulations.
Register for free


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... / Learn more /

More Reference Library
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Practical Guidance for Successful Mammalian Cell Banking and Cell Line Characterization
On Demand
Join us for this informative webinar, presented by the team at Eurofins Lancaster Laboratories, to learn about the various aspects of cell banking and cell line characterization, including GMP production master and working cell banks, GMP non-production (e.g. bioassay) master and working cell banks, R&D cell banks or banking for end of production cells.
Read More


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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