Top Stories
Gottlieb's tenure included record new drug approvals and steps taken to curb opioid abuse.
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FDA Commissioner Gottlieb released a statement on the agency's efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.
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Industry News
Procarta Biosystems has received investment from Novo Holdings REPAIR Impact Fund to the tune of EUR 1.5 million (US$1.7 million), which will be used to develop a new class of antibiotics to tackle AMR.
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A project conducted by research institute CEA-Leti led to the development of a new HIV vaccine approach based on engineered lipid nanoparticles.
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Biopharma News
The new facility, located at the company's headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company's lead gene therapy program.
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Supplier News
Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep's BioSC platform and SSB's single-use technology.
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The companies have signed a license agreement aimed at progressing Iksuda's lead ADC to clinic, with the aim of targeting difficult-to-treat solid tumors.
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Regulatory News
The FDA commissioner plans to leave the agency in April.
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The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company's cleaning and stability testing procedures were inadequate.
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FEATURED TOPICS |
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MANUFACTURING
A properly designed validation program will detect variation and ensure control based on process risk.
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BIOPHARMACEUTICAL ANALYSIS
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.
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BIOSIMILARS/BIOBETTERS
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an advancement over the traditional steady-state analysis of biomolecules.
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INTERPHEX 2019 EXHIBITOR GUIDE
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Catalent Biologics' Bloomington, Indiana facility provides sterile formulation and extensive biomanufacturing and drug product fill/finish capacity across a number of biological drug product formats.
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Distek has revolutionized benchtop-scale bioreactors with our BIOne 1250 bioprocess control station for both mammalian and microbial models.
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By exploiting the strong synergies in bioreactor technology and polymer manufacturing, Eppendorf has emerged as a global player in the bioprocess marketplace.
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PDA is the leading global provider of science, technology, regulatory information, and education for the bio/pharmaceutical community.
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PendoTECH offers low-cost, single use in-line sensors for pressure, temperature, conductivity, UV absorbance, and flow (that are also robust enough for re-use!).
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The Sartorius Group is a leading international partner of the biopharmaceutical industry and the research sector.
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Participate in BioPlan's 16th Annual Global Biopharmaceutical Manufacturing Study. Share your insight on current global and regional trends affecting biomanufacturing and receive a free aggregated summary of this year's results and an updated Top Trends in Biopharmaceutical Manufacturing White Paper. If you complete, the survey, BioPlan will donate $15 (up to $3000) on your behalf to global health charities or you can receive a $15 Amazon e-gift card.
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March 11–13, 2019
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eBook
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This eBook covers method development, analytical techniques, and profiles of new instruments, equipment, and supplies used in the testing and analysis of raw materials, drug substances, and drug products.
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