First Biosimilar Submission to FDA; New Leadership for ISPE, CRS

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Ensuring USP Compliance with Revised Chapters on Weighing
On Demand
Sponsored by: Mettler Toledo

Complex Parenteral Formulations for the Delivery of Peptides, Proteins, Nucleic Acids and Small Molecules
On Demand
Sponsored by: Evonik Industries

Best Practices for Preventing Metal Contamination of Pharmaceutical Products
On Demand
Sponsored by: CEIA

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IVT's Annual Microbiology Week
August 5-7, 2014
Philadelphia, PA

MES 2014
August 14-15, 2014
Philadelphia, PA

Cleaning Validation and Critical Cleaning Processes
August 19-21, 2014
San Diego, CA

July 31, 2014

PharmTech.com

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The Mainstreaming of Continuous Flow API Synthesis
The pharma industry is moving toward commercial-scale continuous processes for small-molecule API manufacturing.

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NATOLI Tablet Press Manufacturing and Refurbishing
Need a new R&D, medium to high-production tablet press? Contact “The Global Leader” in the tablet compression industry. NATOLI Engineering also refurbishes tablet press with results that often exceed the efficiency and functionality of the original.

Learn more about NATOLI’s renowned experience in building and refurbishing tablet presses. All NATOLI Tablet Presses are Made in the U.S.A.

Automating Online Sampling of Bioprocesses
The Modular Automated Sampling Technology platform allows sampling of bioreactors.

Securing the Supply Chain
Regulators and industry leaders take on the task of securing the drug supply chain.

FDA Accepts First Biosimilar Filing
Sandoz is first to file for FDA approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009.

ISPE Names John Bournas as President and CEO
Former healthcare association executive selected to lead International Society for Pharmaceutical Engineering.

Arthur J. Tipton Named President of Controlled Release Society
The president and CEO of Southern Research Institute has been named president of the Controlled Release Society.

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Life Cycle Management Opportunities in Softgel Technologies
On Demand Webcast
To Register Free:

www.pharmtech.com/opportunities

Pfizer to Acquire Vaccines from Baxter
Pfizer announced an agreement to acquire Baxter International?s marketed vaccines for $635 million.

GSK Submits EU Regulatory Filing for Malaria Vaccine Candidate
The regulatory filing marks the first step in the approval process toward making RTS,S available as an addition to existing tools currently recommended for malaria prevention.

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Lyophilization Cycle Design and Scale Up – Practical Methodologies for Developing Cycles
On Demand Webcast
To Register Free:

www.pharmtech.com/cycles

Bristol-Myers Squibb and Ono Pharmaceutical Collaborate on Immunotherapies
Bristol-Myers Squibb and Ono Pharmaceutical will jointly develop and commercialize immuno-oncology drugs for Japan, South Korea, and Taiwan.

Study Shows Capsugel's Capsules as Suitable Excipients in QbD-based Product Development and Manufacturing
Study provides first substantive reference data on key quality attributes of empty capsules.

PCI Acquires Penn Pharma
Packaging Coordinators, Inc. expands its services with acquisition of Penn Pharmaceutical Services.

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Analytical Challenges and Case Studies in Method Development for Fixed-Dose Combinations
On Demand Webcast
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www.pharmtech.com/method_development

Croda Obtains EXCiPACT Certification for Mevisa Site
Croda, an excipients supplier, announced that it has obtained EXCiPACT certification for its excipients manufacturing site at Mevisa, Spain.

I Holland Launches New Packaging Solution to Eliminate Potential Tool Tip Damage
PrimePac tubes, part of the company's new portfolio of packaging, have been specifically designed with a safety zone to hold tablet punches in position to stop damage to the tip face.

Redbiotec Collaborates with GE Healthcare Life Sciences on Vaccine Development and Manufacturing
Redbiotec and GE Healthcare Life Sciences develop a novel manufacturing process for virus-like particles.

SGS Life Science Services to Expand Shanghai Facility
SGS to add testing laboratories for biotechnology, extractables and leachables, and elemental impurities to Shanghai facility.

Solid Dosage and Excipients
Review emerging trends in the formulation and manufacture of solid dosage drugs, as well as the role of excipients in enhancing the functionality of these drug forms.

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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

Manufacturing Equipment & Supplies
Filtration and single-use systems solutions and expertise.

Chemicals, Raw Materials, Intermediates, & Excipients
Visit us at www.sonneborn.com for a free sample of any Sonneborn product.

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