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Delivering Biologics with a Difference
(On Demand)
Sponsored by Baxter BioPharma Solutions

Accelerating Vaccine Development: Regulatory, Biosafety, and Clinical Strategies
(On Demand)
Sponsored by SGS Life Science Services

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INTERPHEX 2015
April 21-23, 2015
New York, NY USA

16th Annual Computer and Software Validation
April 27-29, 2015
Philadelphia, PA USA

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March 26, 2015 PharmTech.com PRINT SUBSCRIBE DIGITAL SUBSCRIBE

News

Lyophilization Cycle Optimization of Cell-Derived Products
While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.
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Implementation of ICH Q3D Elemental Impurities Guideline: Challenges and Opportunities
Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.
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CMOs Plan for Capacity Expansions
Is there enough talent to go around?
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News

FDA Issues Guidance on Lot Distribution Reports for Biologics
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.
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International Transport for Biologic Substances Expands
UPS expands its special commodities program to more countries.
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News

Novartis' Cosentyx Shows Promise in the Treatment of Psoriasis
Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.
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FDA Issues Guidance on Environmental Assessments
The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.
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Learn best practices of successful tableting, and tips and tricks for avoiding common manufacturing problems at Basics of Tablet Manufacturing and Troubleshooting, March 24-26, 2015. Reserve your spot for this hands-on course taught by Natoli Engineering’s technical services and training experts that offers knowledge far beyond what can be learned in textbooks and webinars. Learn More

Biogen Idec Drops the Idec
The company's new corporate name will simply be Biogen.
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CPhI South East Asia Brings Spotlight on Indonesia
The event will take place at the Jakarta International Expo, Indonesia from April 8–10, 2015.
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From Single-Use to Flex Facilities to Manufacturing and more, Biopharmaceutical Development & Production (BDP) Week is the most comprehensive concept-to-commercialization experience for bioprocessing and manufacturing professionals dedicated to creating unique end-to-end solutions that guarantee reproducible results.

Join 800+ peers for 4 days of learning and unparalleled networking in beautiful Southern California on March 30-April 2. Register now and SAVE $200 off the Standard Rate with Code: B15155KPG. Learn more

WHO Joins Forces with ESCMID in the Battle against Global Infections
International day for fighting infection sees European infection specialists advocating vaccines as a viable solution to tackle antimicrobial resistance.
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Recipharm Delivers Serialization Solutions for Abbott in Korea
Recipharm expects to be rolling out further serialization projects during 2015.
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Sartorius Stedim Biotech Forms Pact with em-tec to Develop PAT Solutions for Flow Rate Measurements
The new flow sensors, BioPAT Flow, enable precise, reproducible data to be collected on flow rates and mass balances without coming in contact with the medium during measurement.
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Mundipharma Launches Infliximab Biosimilar (Remsima) in Six European Markets
Remsima has demonstrated comparability to the reference product, Remicade, in terms of safety, efficacy, and quality.
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