July 2016
Volume 40, No. 7 |
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| FOCUS |
Adeline Siew, PhD
Polymers have played a key role as solubilizing excipients. Industry experts explain why polymer structures and functionalities are important considerations in formulation development.
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Adeline Siew, PhD
Lipid-based drug delivery is increasingly being used to tackle oral bioavailability challenges resulting from poor solubility.
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| PEER-REVIEWED RESEARCH |
John P. Jasper, Peter Farina, Ann Pearson, Peter Mezes, Anthony Sabatelli
The author's directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.
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| DATA INTEGRITY |
Jennifer Markarian
Designing systems using the principles of good documentation practice, including validated audit trails, is a key piece of a manufacturing data integrity program.
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| EQUIPMENT CLEANING |
Chris McNulty
Early planning for the integration of clean-in-place systems for equipment cleaning is key.
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| FORMULATION |
Adeline Siew, PhD
Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.
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Sam de Costa
FDA approved the Raplixa, the first spray-dried fibrin sealant, in May 2015 to help control bleeding in adults during surgery.
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| API SYNTHESIS & MANUFACTURING |
Cynthia A. Challener
Recent chiral advances demonstrate promise for API synthesis.
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| TROUBLESHOOTING |
Walter Matzmorr
Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.
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| SUPPLY CHAIN |
Agnes Shanley
Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.
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Agnes Shanley
China and India are also increasing inspections and becoming more exigent about data integrity and cGMPs.
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| PACKAGING FORUM |
Hallie Forcinio
Innovations protect product quality, improve productivity, enhance sustainability, and simplify usage for patients and caregivers.
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| REGULATORY WATCH |
Jill Wechsler
Agency guidance and industry standards aim to reduce lapses and improve quality operations.
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| OUTSOURCING OUTLOOK |
Jim Miller
CDMOs need to be aware that unfavorable public markets put emerging bio/pharma R&D spending at risk in 2017.
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| ASK THE EXPERT |
Siegfried Schmitt
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses standard operating procedures for the regulatory affairs department.
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| FROM THE EDITOR |
Rita C. Peters
CPhI Pharma Awards seek nominations for excellence in development and manufacturing.
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| PRODUCT SPOTLIGHT |
The ambr 250 mini benchtop bioreactor system from Sartorius Stedim Biotech can be used for parallel fermentation and cell culture.
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The LabX from Mettler Toledo has the ability to connect different laboratory instruments to one management system.
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The Double Planetary Mixer (DPM) from Ross, Charles & Son can be used for single-pot mixing and deaeration of viscous formulations such as thick pastes, putties, gels, and other semi-solid products.
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The BIOne single-use bioreactor from Distek is a benchtop scale single-use bioreactor (SUB) system for mammalian cell growth and recombinant protein production.
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| WEBCASTS |
On Demand
The China Food and Drug Administration is to moving upgrade the country's bio/pharmaceutical industry including new manufacturing operations that meet Western standards to meet the medicinal needs of the nation’s population. In this webcast, experts offer insight into opportunities for Western bio/pharmaceutical companies in China, and address lingering and unexpected questions about doing business there.
Sponsored by CPhI China
On Demand
When lab workloads seem too high to handle, analysis results or approvals are late, or lead times are exceeded, it is time to take a closer look at a lean lab approach, especially before investing in new resources such as equipment, premises, or personnel.
Sponsored by Mettler Toledo
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| Events |
August 10-11, 2016
September 12-14, 2016
September 18-21, 2016
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