Biosimilar Manufacturing solution center
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Strategic Procurement For Emerging Pharmas & Biotechs
2/27/2023
Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.
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Analytics And Bioassays Can Safely Fast-Track mRNA-LNP Drug Development
2/23/2023
One main mRNA technology challenge is the formulation of delivery systems like lipid nanoparticles (LNPs). Learn about evading impurities in lipids, the future of mRNA-based genomic medicines, and more.
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How Outsourcing RNA-LNP Production Can Have A Competitive Advantage
2/23/2023
Manufacturing the RNA-containing LNPs is a complex process demanding specialized expertise and experience. Explore some of the challenges of RNA-LNP drug manufacturing and the advantages of outsourcing RNA-LNP formulations.
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Trends In FDA FY2022 Inspection-based Warning Letters
2/21/2023
We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a heightened scrutiny on two product types.
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LNP Formulation For mRNA delivery
2/15/2023
Microfluidic mixing is one of the most effective means to formulate lipid nanoparticles (LNPs) for its scalability and reproducibility. Explore LNP formulation, polishing, sterile filtration of mRNA-LNPs, and more.
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mRNA Product Purification Process Strategies
2/15/2023
Impurities from IVT can induce undesired immune responses and negatively impact translation efficiency. Discover the pros and cons of each option for mRNA purification, challenges, strategies, and more.
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mRNA Product IVT Process Insights
2/15/2023
In vitro transcription (IVT) allows a researcher to tailor synthesis and introduce modifications to produce a transcript. Learn about IVT along with process challenges and strategies.
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mRNA: Challenges And Strategies Related To The DNA Template Process
2/15/2023
Encapsulated mRNA–LNP creation begins with synthesizing the DNA template. Explore the DNA template, DNA template synthesis, the challenges and strategies of generating a DNA template using PCR, and more.
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Introduction To mRNA Manufacturing
2/15/2023
The SARS-CoV-2 virus has changed the course of scientific research around messenger RNA (mRNA). Learn about mRNA manufacturing, the structure of a mRNA molecule, RNase-free considerations, and more.
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New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices
2/15/2023
The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.