Pharmaceutical Technology ePT Weekly
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PharmTech
July 9, 2015
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Top Stories

GSK Sells Two Meningitis Vaccines to Pfizer

The divestment of Nimenrix and Mencevax was to satisfy regulatory clearances when GSK gained Novartis’ vaccines business in an asset swap in March 2015.
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FDA Delays Product Tracing Requirements for Dispensers

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product-tracing information.
/ read more /


GSK Plans Increase in Antibiotic Production in Singapore

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.
/ read more /

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KNOWLEDGE

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Industry News

CHMP Recommends 10 Medicines for Approval

Enzyme replacement therapies for rare diseases and cancer treatments are recommended for approval.
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Data Integrity Questioned at Indian API Manufacturer; Indian Pharma Faces Compliance Challenges

A recent Ernst & Young survey highlights the challenges facing Indian pharma.
/ read more /


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Supplier News

Aeras and IDT Biologika Partner to Develop Vaccines

IDT Biologika acquired Aeras' vaccine manufacturing facility, and the companies will work together on tuberculosis vaccine development.
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Gerresheimer Sells Glass Tubing Manufacturing Business to Corning

Gerresheimer sells its glass tubing manufacturing operations to focus on pharmaceutical packaging business.
/ read more /


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eMDR is Coming: How to Enhance Collaboration with the FDA
The FDA is tasked with the job of ensuring that all products produced within medical device, pharmaceuticals, biologics, and all other industries are produced safely and effectively. Learn about benefits of using the FDA's eMDR program and best practices of implementing an eMDR system to meet specific business needs.
Download White Paper Now



Bio/Pharma News

Bristol-Myers Squibb Makes Changes in R&D Locations and Focus

Bristol-Myers Squibb builds R&D facilities in Massachusetts and San Francisco and discontinues discovery research in virology.
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Celgene to Pay $1 Billion for Decade-long Partnership with Juno Therapeutics

The partnership will focus on the development of CAR T-cell therapies and other programs related to T-cell technology.
/ read more /


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Regulatory News

USP Stresses Pharmacopeial Standards at CPhI China

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.
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ICH Appoints New Director of the ICH Secretariat

The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.
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More Regulatory News

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Just released – Tablet Press Replacement Parts and Accessories Catalogs
In addition to efficient, durable and highly-performing tablet compression tooling, Natoli Engineering Company also offers tablet press replacement parts for most makes and models of machines as well as tablet compression accessories to clean, maintain, analyze, and protect your tooling. Download a PDF of our new catalogs or request a quote online at natoli.com.



FEATURED TOPICS

EXCIPIENTS

Colorcon Adds Lab in Beijing

Colorcon expands its presence in China with a technical service center to serve the northern region.
/ read more /

STANDARDS AND REGULATION

FDA Guidance Seeks More Effective Postapproval Change Strategies

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.
/ read more /

PACKAGING AND LABELING

Considering Full Serialization

Although US law does not require full traceability until 2023, companies could benefit from implementing it now.
/ read more /

TROUBLESHOOTING

Tips for Automated Washing

Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.
/ read more /

PEER-REVIEWED

Evaluating Disinfectant Efficacy of a Silver-Based Disinfectant

A disinfectant composed of a low-concentration suspension of silver ions is completely sporicidal with only a one-minute contact time.
/ read more /

OUTSOURCING

BioPlan Associates Releases 2015 Edition of its Annual Survey

The 12th Annual Report and Survey of Biomanufacturing is now available.
/ read more /


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Solubility Enhancement
Solutions Using Predictive Analytics & Molecular Modeling

On Demand
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.
Learn More



Webcasts

Successful Binding of Peroxide-Sensitive APIs

Tuesday, July 7, 2015, 10 am EDT

In this live webinar, experts will showcase how to formulate a peroxide-sensitive drug using a binder that combines high binding strength with no peroxide formation at all.
Sponsored by: BASF


Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Fragments

On Demand
Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.

Sponsored by: Tosoh Bioscience LLC


more webcasts

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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.
Learn More


on pharmtech tv

PharmTech TV

What to Expect at the 2015 PDA/FDA Joint Regulatory Conference

Application of External Lubrication in Tablet Production

Trends and Concerns in Capsule Production

Feeding Powders in Pharmaceutical Processes

Events

DCAT Sharp Sourcing 2015

July 16, 2015 | New Brunswick, NJ

29th Annual Symposium of The Protein Society

July 22–25, 2015 | Barcelona, Spain

10th Annual Manufacturing Execution System (MES)

August 12–13, 2015 | Philadelphia, PA


more events

REFERENCE BOOKS

Process Analytical Technology Resource Guide Combo

A compilation of informative, useful articles from Pharmaceutical Technology designed to help you meet the challenges of process analytical technology, be more efficient in testing, reduce over-processing, enhance consistency, and minimize rejects.
/ Learn more /


More Reference Library

eBOOKS

Bioprocessing and Sterile Manufacturing 2015 eBook

This eBook features articles on sterility testing, disposable technologies, parenterals, facility planning, mAb formulation, and more.


more ebooks

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