Biosimilar Insights
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Consolidating The Supply Chain For mRNA
2/12/2024
Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
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Reprogramming Human Cells With bit.bio's Mark Kotter, M.D.
2/12/2024
The concept of programmable biology is fueling a new breed of biotech, one that requires the marriage of computational and traditional science (and both computational and traditional scientists) on the entire journey from discovery to commercial. Bit.bio is exemplary of this new breed.
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Combining Scientific Knowledge And Advanced Technology
2/9/2024
Your partner in contract production and development using the end-to-end business model. We specialize in the production of sterile biotechnological products in a manufacturing plant that meets the requirements of GMP.
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Impact Of Glycosylation On The Effector Functions Of Monoclonal Antibodies
2/9/2024
In an example using rituximab and its biosimilars, explore the significance of minor differences of glycosylation in antibodies and its impact on their properties and functionality.
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Mycoplasma Contamination In Biopharmaceutical Manufacturing
2/9/2024
Learn how following strict laboratory practices and conducting routine testing for Mycoplasma contamination using nucleic acid-based assays can help ensure the production of safe and high-quality biopharmaceutical products.
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
2/9/2024
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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Quantitation Of Monoclonal Antibodies In Serum
2/8/2024
Monoclonal antibodies (mAbs) are a rapidly growing group of targeted therapeutics. Gain insight into the importance of optimized bioanalytical assay platforms for mAb development.
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Metabolite And Nutrient Analysis As Crucial Components For Optimal Upstream Process
2/8/2024
Discover how insights into cell metabolism can further enable the development of efficient cell culture processes through tailored nutrient supplementation and monitoring.
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Development And Regulation Of Veterinary Monoclonals
2/8/2024
Although veterinary mAbs have achieved commercial success, ongoing discussions and clinical developments surrounding them are expected to outline a clear regulatory pathway in the near future.
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Revolution In The EU Pharmaceutical Legislation Ahead
2/8/2024
Discover the impact revised pharmaceutical legislation will have on the industry by superseding regulations that have fostered the availability of safe and effective medicines for the past two decades.