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Top Stories
New funding brings competitors, and a leading healthcare products distributor, into the standardization effort.
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Catalent builds on its investment in cell and gene therapy development and manufacturing with the acquisition of MaSTherCell Global.
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Industry News
The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.
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The FDA Commissioner plans to address drug prices, the drug approval process, and supply chain issues during his time as commissioner of FDA.
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Supplier News
The program supports Emerson’s digital transformation initiative which encourages employees to learn at a faster pace through immersive experiences that enhance safety and overall operational performance.
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The new facility includes six classified environment rooms with space to expand.
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Bio/Pharma News
A growing number of pharma executives see investment in machine learning and big data as a top priority, according to a 2020 GlobalData survey.
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Aimmune plans to introduce the antibody as an adjunctive treatment with its Characterized Oral Desensitized ImmunoTherapy programs to research treatment outcomes in patients with food allergies.
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Regulatory News
FDA published draft guidance for applicants seeking licensure of a proposed biosimilar or proposed interchangeable biosimilar.
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The two agencies are collaborating to support a robust biologics marketplace by taking steps to deter anti-competitive business practices.
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Featured Topics |
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REGULATORY
Increased reliance on foreign producers raises concerns and spurs collaborations.
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FORMULATION
Researching excipient grades and sources, as well as screening suppliers and materials, form the basis of programs to mitigate risk.
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MANUFACTURING
Consider current large-scale practices for oligonucleotide synthesis as a basis for improving commercial-scale platform strategies.
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PEER-REVIEWED RESEARCH
This paper discusses what causes cross-linking, how cross-linking is addressed with addition of enzymes, and consideration for occasional high results that can be obtained during release testing.
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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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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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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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Events
February 17–19, 2020
February 23–26, 2020
March 1–5, 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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