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Top Stories
The landmark decision determined that biosimilar makers can notify manufacturers before receiving FDA approval.
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FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
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Podcast
Capsugel won the Excellence in Formulation Award in the CPhI Pharma Awards 2016 with its intrinsically enteric capsule technology, which provides enteric protection and delayed release without a functional coating. Keith Hutchison, senior vice president of Research and Development, Capsugel, speaks with Pharmaceutical Technology about the applications of this technology in formulation development.
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Industry News
The three regulatory agencies have agreed to data requirements for development of new antibiotics.
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The United Kingdom's Center for Process Innovation (CPI) is investing in a new project, Microstar, which seeks to reduce risk for formulators through the development of accelerated screening methods for predictive design.
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Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
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Supplier News
The new training center will feature technologies that boost biomanufacturing.
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The company announced that it is fully compliant with the 2017–2023 serialization and aggregation requirements.
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Changing the functional role of capsules in drug delivery
By combining polymer science, engineering and formulation know-how, we are creating breakthroughs in capsule and encapsulation technologies that are changing the functional role of capsules in medical research, drug formulation and drug delivery. Capsugel provides leading-edge solutions that protect high value compounds, optimize delivery to targeted sites in the body, and ensure the best operational performance in capsule filling.
 To learn more, visit www.capsugel.com. |
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Regulatory News
Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
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Connect Upstream for Increased Titers
Increase your titers by developing your own optimized medium and feed strategy in 5 months. The CHOptimizer® media optimization tool box combines the ambr® 15 with an integrated DoE approach for efficient testing of different media mixtures and for spent media analysis.
 Our media expert will guide you through this process. |
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MANUFACTURING
As cost pressures mount as a result of multiple biologics being developed for the same indication, manufacturers can harness process efficiencies to maintain the value of legacy products.
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PEER-REVIEWED RESEARCH
In this study, the authors describe a forensic microscopy approach to characterize particles that were visually observed during stressed stability testing of an ophthalmic solution formulation.
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SUPPLY CHAIN
Serialization and complementary authentication technologies are needed in order to meet DSCSA and FMD regulations.
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Events
June 19–22, 2017
June 22, 2017
July 13–14, 2017
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REFERENCE BOOKS |
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A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
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eBOOKS
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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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