June 03, 2021
Cover Story
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The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.
June 03, 2021
Peer Reviewed
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In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using two-level factorial design.
June 03, 2021
Development
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In addition to ADCs, other types of highly potent biologics require specialized manufacturing skills.
June 03, 2021
Development
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Particle engineering is a vital tool in overcoming many formulation challenges, and technological advances are enabling developers to achieve the full potential of pipeline molecules.
June 03, 2021
Manufacturing
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Consider best practices for manual or clean-in-place procedures.
June 03, 2021
Manufacturing
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Automation offers benefits for sterile manufacturing in 503B outsourcing facilities.
June 02, 2021
Manufacturing
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Process intensification in continuous biopharmaceutical processing can change the way the equipment is used and thus affect cleaning methods.
June 02, 2021
Quality/Regulations
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International pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.
June 02, 2021
Analytics
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As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.
June 02, 2021
Outsourcing
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Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and development time efficiencies.
June 02, 2021
Regulatory Watch
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Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.
June 02, 2021
From The Editor
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Bio/pharmaceutical manufacturers have made a good first step toward global vaccination through pledging doses at no- to low-profit rates.
June 02, 2021
From the Chairman
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Technology advances foster new therapies.
June 02, 2021
Ask the Expert
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Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.
June 02, 2021
Product Spotlight
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Tosoh Bioscience introduced the TSKgel FcR-IIIA-5PW HPLC column, a semi-preparative affinity column based on a recombinant FcγRIIIA receptor ligand bonded to porous 10 µm polymethacrylate particles.
June 02, 2021
Product Spotlight
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The TipFil Syringe Filler from TurboFil Packaging Machines is a benchtop syringe filling machine that offers full control of filling parameters in single or dual operation and fills at a rate of up to 12 pieces per minute.
June 02, 2021
Product Spotlight
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Shimadzu released the TOC-1000e, an analyzer in the eTOC series of on-line TOC analyzers formulated for pure water applications.
June 02, 2021
Product Spotlight
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The ROSS Double Planetary Mixer from Charles Ross & Son Company is available with an optional weighing system for precise measurements throughout the batching procedure.