Pharmaceutical Technology ePT Weekly
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PharmTech
November 30, 2017
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In this issue:

Sun Pharmaceutical Recalls Riomet

Comparing Endotoxin Detection Methods

EMA Releases Guidelines on Advanced Therapies

Top Stories

EMA to Relocate to New HQ in Amsterdam in Wake of Brexit

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.
/ read more /


Will Pharma Meet the Drug Tracking Deadline?

Manufacturers and trading partners struggle to meet drug tracking requirements
/ read more /


PharmTech 2017 Employment Trends

The editors of Pharmaceutical Technology invite you to participate in the annual employment survey for individuals involved in bio/pharmaceutical development, formulation, or manufacturing.

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Industry News

Sun Pharmaceutical Recalls Riomet

The company is recalling product because of microbial contamination.
/ read more /


Small and Specialty Companies Shape Pharma’s Evolving Outsourcing Landscape

Pharma trends translate into increased need for not only external partners, but those will capabilities that can help advance today’s drug development and manufacturing challenges.
/ read more /


More Industry News

Supplier News

GE Healthcare Completes Acquisition of Bioprocessing Start-Up

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.
/ read more /


Avista Doubles API Manufacturing Capacity at Colorado Facility

Avista Pharma Solutions facility and equipment upgrades at its Longmont, Colorado facility support processing of potent compounds.
/ read more /


More Supplier News
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Bio/Pharma News

Teva Restructures Company and Leadership

In the wake of generic-drug pricing pressure and declining revenues, Teva has restructured its commercial business and made executive leadership changes.
/ read more /


AstraZeneca Establishes Joint Venture in China to Develop Innovator Drugs

The joint venture will focus on the discovery, development, and commercialization of potential new drugs for the global market as well as speed delivery of new medicines to China.
/ read more /


More Bio/Pharma News

Regulatory News

EMA Releases Guidelines on Advanced Therapies

The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.
/ read more /


Samsung Bioepis Receives Approval for First Trastuzumab Biosimilar, Ontruzant, in Europe

Ontruzant is the first biosimilar of Roche’s Herceptin (trastuzumab) to be approved in Europe.
/ read more /


More Regulatory News
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FEATURED TOPICS

Drug Delivery

ODTs Dissolve Drug Administration Challenges

Ralph Gosden, head of product development at Catalent’s Swindon, United Kingdom site, explains the opportunities of orally disintegrating tablets as a patient-centric dosage form.
/ read more /

Solid/Semi-Solid Dosage

Selecting the Appropriate Technology for Oral Bioavailability Enhancement

Model-based formulation and technology selection methodologies facilitate rapid product development.
/ read more /


Peer-Reviewed Research

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part I: Regression Control Chart

In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested.
/ read more /

Analytics

Comparing Endotoxin Detection Methods

Inadequate endotoxin testing places patients at risk. Knowing the relative strengths and weaknesses of available test methods is crucial to maintaining quality and safety.
/ read more /


UPCOMING WEBCASTS

Risk Assessment and Testing Requirements for Elemental Impurities in Pharmaceutical Products
Live Webcast: Tuesday, December 12 at 11:00am EST
Register now


The Journey to a Successful Biologic License Application
Live Webcast: Thursday, December 7 at 12:00pm EST
Register now


ON DEMAND WEBCASTS

Partnership of Chemical Engineers and Chemists Optimizes Process Development
On Demand
Learn more


Beyond the Buy: The Critical Role of Data, Relationships, and Experience in Comparator Sourcing Success
On Demand
Learn more


Accelerating Method Transfer: Effective Automation of Biological Assays
On Demand
Learn more


Challenges in the Development of Complex Small-Molecule Drugs
On Demand
Learn more


Analytical Challenges in Extractables Studies of Plastic Single-Use Bioprocess Bags
On Demand
Learn more


Events

Achieving Efficient Facilities

December 11–12, 2017

Next Frontier for Single-Use Technologies

December 12–13, 2017

Pharmapack Europe

February 7–8, 2017

more events

eBOOKS

Biologics and Sterile Manufacturing

New technologies, including single-use systems, are leading the push for faster production and higher titers. At the same time, ensuring quality in raw materials and water systems, and controlling contamination are paramount. In this Biologics and Sterile Manufacturing eBook, the editors explore key technology, process, and operational topics.


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