Top Stories
FDA's Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.
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Alexandre Juillerat, PhD, innovation senior scientist at Cellectis, discusses novel construct UCART123, an investigational agent that is on deck to be the first gene-edited T-cell product in the United States.
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Trump met with pharma manufacturers and makes a statement focused on domestic manufacturing, FDA approvals, and drug pricing.
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PODCAST
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
PAT, quality by design, process controls, and analytical advances for small- and large-molecule drugs are on agenda for IFPAC 2017.
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The company issues a voluntary nationwide recall due to the presence of particulate matter in a single vial.
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Supplier News
The SCIEX PA 800 Plus Pharmaceutical Analysis system is used to identify and quantify glycans to ensure therapeutic efficacy.
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The medical cannabis producer has become compliant with EMA's GMP standards.
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Bio/Pharma News
Teva said it plans to appeal a district court decision that invalidated several of the company's Copaxone patents.
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The companies will split Actelion's drug discovery and early-stage clinical development assets into a new Swiss biopharmaceutical company.
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Regulatory News
The agency finds repeated CGMP violations at Porton Biopharma, Limited.
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The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.
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QUALITY
As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.
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PACKAGING
Moisture uptake during the end-to-end manufacturing process and supply chain can affect product quality. Simulation tools based on mechanistic models help define storage and handling requirements for oral solid-dosage drugs.
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ANALYTICS
Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.
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DRUG DEVELOPMENT
Isothermal titration calorimetry and differential scanning calorimetry are valuable tools that can help accelerate drug development.
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Events
February 27–March 2, 2017
March 5–9, 2017
March 22–24, 2017
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REFERENCE BOOKS |
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Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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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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