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FUJIFILM plans $1.2 billion investment in major US manufacturing facility
Proposed additions to the cell culture manufacturing facility are set to make the site one of the largest cell culture biopharmaceutical CDMO facilities in North America.
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Biopharma
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Seasonal variation of microbial contamination in pharmaceutical cleanrooms
With the outdoor environment being a primary contamination source in the pharmaceutical cleanroom, measures like good manufacturing practices (GMP) is key to reduce this risk, a paper asserts.
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ebook: Twin-screw extrusion for pharmaceutical applications
This compendium explains how hot-melt extrusion can help overcome common challenges in pharmaceutical development, with guidance on all stages of the HME process from formulation characterization to process design/development, and downstream processing.
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Novel medicine could address short stature in children
Some patients had excellent responses in Phase II of an innovative trial of vosoritide in paediatric hypochondroplasia, data shows.
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CRISPR technologies fuelling haematological innovations
Greater use of CRISPR-based therapies in clinical trials is expected to drive further advancements in precision medicine, GlobalData states.
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EFPIA reaction to European Parliament plenary vote
Following the recent European Parliament plenary vote, EFPIA asserts that aligning the next revision of the pharmaceutical legislation to increase Europe’s competitiveness will be a challenge.
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New partnership to advance European oligonucleotide manufacturing
Once built, the new manufacturing facility in Berlin is anticipated to help drive the production of high-quality oligonucleotide therapeutics.
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Patent expiration to drive biosimilars market expansion to 2032
Cost effectivity of biosimilars is predicted to be a key contributor to growth of the global biosimilar market to 2032, research states.
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Unique testing regimen could prevent nuclease contamination
Biannual routine testing in the laboratory reduces both the likelihood of nuclease contamination occurrence and its impact, a study suggests.
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AACR: BTK degrader could treat CNS B-cell malignancies
New data suggests the small molecule therapeutic could also benefit autoimmune disorders with involvement in the central nervous system, such as multiple sclerosis.
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Advancing microbiome innovation
In the fourth instalment of EPR's ‘Microbiome therapeutics: microscope to medicine’ series, Emilie Plantamura, Deputy Chief Medical Officer at MaaT Pharma, examines the promising potential of microbiome therapeutics beyond Clostridium difficile infection, particularly in the onco-haematological field.
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Achieving FAIR bacterial identification
A study has reported a noninvasive assay for detecting Gram-negative bacteria biofilms that do not disrupt the pattern of bacterial growth.
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Innovative personalised immunotherapy approved for multiple myeloma
Approval of the cell therapy by the US FDA could provide a treatment-free respite as early as first relapse for patients with multiple myeloma.
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The role of outsourcing in antibody drug manufacture
While manufacturing capacity was a major challenge in early development of monoclonal antibody drugs (mAbs), outsourcing to CDMOs likely helped to remedy this, research reports.
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Antibody-immunotherapy treatment shows benefit in serious endometrial cancer
The novel combination cancer therapy facilitated “exceptional” responses in some patients enrolled in a Phase II study for endometrial cancer.
