Search results for " report"
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Navigating Emerging Markets: Middle East and North Africa
In a report to the Office of the United States Trade Representative, PhRMA called out these two countries as requiring review. In Algeria, PhRMA cites weak patent protection, government-mandated price…
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Quality by design for biotechnology products—part 1
Consequently, companies may be able to develop an efficient, cost-effective commercial process for such products, and benefit from a more flexible reporting mechanism for changes to the application af…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
The Alliance for Regenerative Medicine reports that as of the end of 2018, 263 cellular therapies and 362 gene-modified cellular therapies were being evaluated in clinical trials (see Figure 1) (4). T…
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Emerging Therapies Test Existing Bioanalytical Methods
Bone marrow transplants, a similar form of treatment, have become relatively common since the initial reported use in 1968.
Gene therapy, the transfer of genetic material into specific cells to mo…
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What’s New in Upstream Technologies
The company also reports that it supplies process buffers at a fraction of the resources and facility space, resulting in a more streamlined buffer suite and a more efficient manufacturing process. Th…
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Biomanufacturing: The Cost of Unskilled Workers
First, a 2018 report from BioPlan Associates estimates there are well over 10,000 therapeutics in R&D, both drugs (chemical substance pharmaceuticals) and biopharmaceuticals (biotechnology-derived pha…
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State of the Biopharmaceutical Industry: Lessons from 2018 Survey Data
The results, published in the Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, provide a detailed, data-rich look at current trends in the biopharmaceutical industr…
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Understanding Validation and Technical Transfer, Part 3
Initially, development information can be kept in research or laboratory notebooks, but as clinical use becomes likely, formal development reports and initial validation work should be prepared, revie…
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Making the Move to Continuous Chromatography
There needs to be a way to analyze and report these data seamlessly, as well as detect adverse trends in performance,” she explains.
Regulatory aspects are the second area of concern. Here, Le…
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Preclinical Evaluation of Product Related Impurities and Variants
In addition, it has been reported that GCSF has a free cysteine residue (cys-17) that can trigger aggregate formation, and so post-manufacturing aggregation of GCSF is a possibility (13). Recombinant …