Biosimilar Development solution center

  1. COGs Process Economics For Autologous Cell Therapy 8/11/2023

    Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and insights from scientists and R&D. Discover how cell therapy manufacturers can combat these costs.

  2. What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product 8/11/2023

    Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.

  3. Oligonucleotide Manufacturing: How To Get A Strong Start 7/26/2023

    If you’re developing an antisense oligonucleotide, siRNA, or other oligonucleotide therapeutic, you’re aware of these molecules' potential. Explore 5 keys to success for oligo synthesis, scale-up, and manufacturing.

  4. Determining RNA Integrity And Purity By Capillary Gel Electrophoresis 6/30/2023

    To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.

  5. Lipid Nanoparticle Compositional Analysis By UHPLC-CAD 6/30/2023

    Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.

  6. Establishing Analytical Methods For mRNA-Based Therapies 6/13/2023

    Here, we provide a detailed description of assays for sequence identification and LNP composition, two CQAs of mRNA-LNP products, that support the development of safe and effective mRNA therapies.

  7. The Global Market For Generic Sterile Injectables To Double In Value By 2032 5/15/2023

    According to new analysis at insightSLICE, the global generic sterile injectable market size was estimated to be $79.95 billion in 2022 and is expected to grow to reach $159 billion by 2032. What are the key factors and trends driving this growth? This author shares the key data-led insights.

  8. AAV Full/Empty Capsid Separation Using Mechanistic Modeling 5/1/2023

    In this study, we used mechanistic modeling to investigate how AAV-resin interactions are affected when MgCl2 is used as an elution additive.

  9. 5 Characteristics Of The Automated Microbiology Lab Of The Future 4/24/2023

    The modern microbiology laboratory is starting to look very different from the laboratory of 10 years ago, and it will continue to evolve in the next few years. There are a number of innovations being implemented now or are in progress that can signal the path that many microbiology laboratories will follow.

  10. The Global Market For Generics & Biosimilars Through 2032 4/14/2023

    According to new market research from insightSLICE, the global market size for generic drugs (including biosimilars) was estimated to be $566.85 billion in 2022 and is expected grow at a CAGR of 5.7% from 2023 to reach a value of $990 billion by 2032. This article shares key insights from the market research.