Top Stories
Human antibody for Zika virus could help in the treatment and prevention of the infection.
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An influx of millennial workers may have an impact on whether pharma manufacturers choose to implement IIoT technology.
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Andrew Bulpin, head of Process Solutions Strategic Marketing and Innovation, MilliporeSigma discusses the company's Emprove Program, winner of the 2016 CPhI Award for Regulatory Procedures and Compliance.
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Industry News
The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.
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FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.
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Supplier News
Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.
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The company announced that it would now be offering a portfolio of fresh and cryopreserved human and animal hepatocytes for ADME-Tox testing.
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Bio/Pharma News
The company said that it has successfully completed its first in-orbit experiment using its miniature end-to-end space laboratory.
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The companies will be expanding their collaboration to discover novel therapies that will include up to eight additional targets using CytomX's proprietary Probody platform.
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Regulatory News
The agency sent a warning letter to Badrivishal Chemicals & Pharmaceuticals detailing several CGMP violations.
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FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.
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QUALITY
A robust quality agreement and good communication scheme can help avoid and alleviate regulatory concerns.
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ANALYTICS
Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall lab efficiency.
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Events
March 30, 2017
April 3–5, 2017
April 24–26, 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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Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain. |
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