Search results for " report" in Articles / App Notes
Article
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 …
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Ensuring Sterility in Small-Scale Production
…as defined in FDA’s aseptic processing guidance (1), the Parenteral Drug Association’s Technical Report #62 (2) on manual aseptic processing, and in EudraLex Volume 4, Annex 1 (3). In other words, th…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
According to Cytiva, the cost of a KUBio plant can be as much as 45% lower than a comparable, traditional facility
This year, Process Development Forum will continue to report on drug approvals, i…