Biosimilar Manufacturing solution center

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.