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Top Stories
Updates on COVID-19 vaccine candidates, FDA policies, company partnerships, and more.
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Biopharmaceutical companies and federal agencies have been working overtime and assuming considerable risk to be able to supply billions of doses of any safe and effective preventive.
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Industry News
Michelle McMurry-Heath will assume the role of BIO president and CEO on June 1, 2020 after Jim Greenwood, who has led the organization since 2005, retires from the positions.
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The CHMP has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms.
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Webinar: Where to Place Sensors & Why :
Sign up to learn Vaisala’s 5 simple rules regarding sensor placement during validation/mapping studies. Along with a review of the regulations and industry guidance on mapping, we will discuss a unique method used to reduce the total number of sensors required while ensuring your study remains defensible under audit.
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Supplier News
HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.
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Evonik opened a new facility for GMP manufacturing of bioresorbable polymers and excipients for pharmaceutical and medical applications in Birmingham, AL.
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Bio/Pharma News
Participants in two dosing cohorts in Moderna’s mRNA-1273 study reached or exceeded neutralizing antibody titers generally seen in convalescent sera.
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The Center for iPS Cell Research and Application Foundation and the Cell and Gene Therapy Catapult have announced the launch of a new collaborative research project that will focus on induced pluripotent stem cell characterization.
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Regulatory News
A temporary restraining order was entered against Xephyr LLC, doing business as N-Ergetics requiring the company to immediately stop distributing colloidal silver products.
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Some observers fear that political interference in the process may erode confidence in the scientific basis for FDA regulatory decisions.
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Featured Topics |
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MANUFACTURING
A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.
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PEER-REVIEWED RESEARCH
The article reports on the CuDAL-Excel program, a set of MS Excel programs transformed and extended from Bergum’s CuDAL version 2 SAS program, designed for industry practitioners to calculate the USP passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios, and for both immediate release and extended release requirements.
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DEVELOPMENT
Many antibody-drug conjugate therapies are in the pipeline; however, only a handful have been approved. What are the bottlenecks?
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eBOOKS
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The Pharmacopoeia Compliance Series features a description of ways bio/pharma companies can participate in monograph development, a practical approach to pharmacopoeial compliance, and a summary of this 12-part series.
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