Top Stories
The deal is expected to close during the first half of 2021.
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The event, which was originally scheduled to take place April 28–30 at the Javits Center in New York City, has been rescheduled for July 15–17 at the same location.
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2019 PDA Quality Week | Dec. 9-13 | Washington, DC
The Week is comprised of three individual, but contiguous events designed to educate you on all aspects of QRM. Each offering provides a different perspective, starting with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept.
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Industry News
The action involves allowing specific National Institute for Occupational Safety and Health-approved respirators not regulated by FDA to be used in healthcare settings to increase the number of respirators available in the United States.
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The Indian government has issued a notification of the restriction on the export of 26 APIs and formulations, including paracetamol, progesterone, and vitamin B12, as a result of the outbreak of COVID-19.
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The NEW Virsa Raman Analyser
Renishaw has developed the Virsa Raman Analyser using its expertise in optical design and detector technologies. It combines the power of laboratory–grade Raman with the convenience of a transportable unit. Use Renishaw's latest high-performance Raman spectroscopy system, to take your spectroscopic analysis away from the confines of the laboratory microscope to new samples and environments.
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Supplier News
The acquisition will expand Nexelis’ immunology testing expertise.
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The technology enables the rapid production of large numbers of recombinant antibodies at 80-mL scale.
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Bio/Pharma News
The new center expands the company’s R&D capabilities and will help it advance its portfolio of rare disease gene therapy programs.
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The therapy works by transferring pathogen-specific antibodies from plasma gathered from recovered individuals into an infected patient, which may help the patient’s immune system respond and increase recovery.
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Know-How to Advance Your Sterile Product
With the installation of a new AST fully-robotic aseptic filling line, Pii has available capacity to handle small to medium-batch production of commercial and clinical materials. This latest expansion has further strengthened our ability to support customers across the entirety of their product development and manufacturing needs to bring high-quality dosage forms to patients.
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Regulatory News
European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.
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A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.
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Featured Topics |
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MANUFACTURING
Tackling process development early on can better optimize manufacturing processes for emerging therapies.
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QUALITY/REGULATIONS
While new industry guidance documents issued by FDA speak to the agency’s efforts to promote the development of new gene therapies, certain hurdles remain to challenge stakeholders.
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PEER-REVIEWED RESEARCH
The authors present a simple-to-use Microsoft Excel-based statistical tool that uses cumulative sum techniques to aid retrospective understanding of data trends.
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ANALYTICS
As compounds become more complex in nature and biological ingredients are more widely used, stability testing approaches must follow suit and provide flexibility for developers.
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A Faster Oncology Drug Product with InnoOneTM
InnoOneTM is an end-to-end, high potent drug product service, offering all the support you need to bring your high potent product to market. At Servier, we guarantee containment suite exclusivity, ensuring quality and mitigating risk. We rely on our history of excellence to help you optimize your process, bringing your drug product to market quicker and more efficiently.
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TAKE THE SURVEY
Expert input is needed for the bio-industry's most in-depth, global benchmarking and analysis study, which examines current global and regional trends affecting the bioindustry. Participants who complete the survey receive a free aggregated summary of the study results, a free whitepaper on the Top 15 Trends in Biopharmaceutical Manufacturing, and the opportunity to share insight about trends in biomanufacturing. For each completed survey, BioPlan Associates will contribute $10 (up to $3000) to a global health charity.
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WEBCASTS
Complex Liquid Formulations: Solutions for Scale-Up Challenges
Tuesday, March 17, 2020 at 1pm EDT | 12pm CDT | 10am PDT
Learn More
Lonza Capsugel® – The Right Partner for Your Next Drug Development Project
Thursday, March 12, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
Learn More
Introducing the New Portable XRF Analyzer for Identity Testing of Pharmaceutical Ionic Salts
Wednesday, March 11, 2020 at 10am EDT | 9am CDT | 2pm GMT | 3pm CET
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Sterile Filling Challenges for Early-Phase Product Development
Thursday, March 19, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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How to Perform Ignition and Drying Methods Such as USP <281> and USP <731> Safely Without Sacrificing Performance
Thursday, March 26, 2020 at 11am EDT | 8am PDT | 3pm GMT | 4pm CET
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Events
March 16–17, 2020
March 18–19, 2020
March 23–25, 2020
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eBOOKS
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In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.
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