• Viral Clearance: 7 Chromatography Column Considerations
    Viral Clearance: 7 Chromatography Column Considerations

    Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.

  • USP Highlights Biosimilar Analytical Development Challenges, Possibilities
    USP Highlights Biosimilar Analytical Development Challenges, Possibilities

    During our conversation about the FDA’s most recent comparability guidance, I picked one USP expert's brain about the challenges of establishing a biosimilar analytical development program, as well as why certain types of data may be more difficult to come by than others. These challenges are responsible for further complicating the question about which types of data are still necessary, and why.  

  • FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?
    FDA’s “Show Me The Data” A Recipe For Tailored Biosimilar Development?

    In this first of what will be a two-part article, USP's Fouad Atouf highlights the challenges presented by the FDA’s newest guidance while remaining optimistic that the large amount of data recommended today will open doors to more efficient development in the (hopefully) near future.

  • Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance
    Why We Should Celebrate The FDA’s Biosimilar Comparative Analytics Guidance

    Despite the importance of the process the FDA is outlining in the guidance, I’ve surprisingly heard little chatter — positive or negative — about what the agency is now outlining and what this may mean for biosimilars and the biosimilar regulatory paradigm moving forward. Here are a couple of the biggest takeaways to note.

  • Stop Compromising Between High Yield And High Purity In Downstream Purifications
    Stop Compromising Between High Yield And High Purity In Downstream Purifications

    Mixed-mode resins are often used when unimodal resins fall short of providing the required process productivity and/or process economics. To overcome this deficiency, Bio-Rad developed the Nuvia aPrime 4A Resin with an optimal balance of ion exchange and hydrophobic interactions to deliver simultaneous purity and yield of therapeutic proteins and monoclonal antibodies that are typically difficult to purify.

  • A Model System For Fast Screening Of Optimal Protein Purification Conditions
    A Model System For Fast Screening Of Optimal Protein Purification Conditions

    This study in an overview of a model system for screening optimal protein purification conditions on a mixed-mode cation exchange resin using a statistical software–generated design of experiment (DOE) model with ChromLab Software’s Multivariable Scouting (MVS) function on the NGC Chromatography System.

  • Addressing New Chromatography Challenges With Fiber Adsorbents
    Addressing New Chromatography Challenges With Fiber Adsorbents

    A new adsorbent material using a novel proprietary structure overcomes the diffusional and flow limitations of packed bed chromatography purification systems and also aims to address the capacity issues of chromatography membranes.

  • Virus Reduction Of An Affinity Capture Step - Viral Clearance For Protein A
    Virus Reduction Of An Affinity Capture Step - Viral Clearance For Protein A

    Evaluating how much a process step contributes to viral clearance is an essential part of process validation in order to be sure you are manufacturing safe drugs. Learn more about how HiScale 10/40, packed with MabSelect PrismA, is a reliable choice for the capture step in a virus clearance study.

  • Viral Clearance: The Basics On How To Conduct Effective Studies
    Viral Clearance: The Basics On How To Conduct Effective Studies

    Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.

  • Your Strategy To Manufacture, No Longer A One-Size-Fits-All
    Your Strategy To Manufacture, No Longer A One-Size-Fits-All

    The traditional method of big batch manufacturing must change as companies move away from the one-size-fits-all blockbuster model toward more innovative, targeted biologics that deliver better outcomes.

  • The Value Of Digital In Biopharma
    The Value Of Digital In Biopharma

    By working together across the biopharma industry, digital technology can be leveraged and data science can reengineer key elements of the drug manufacturing process to ease commercial scale-up.

  • Translating Biopharma Knowledge To Cell And Gene Therapies
    Translating Biopharma Knowledge To Cell And Gene Therapies

    Streamlining, connecting, and automating workflows to shape the future of cellular treatment delivery has the potential to transform how we treat and potentially cure once life-threatening diseases.

  • 3 Crucial Discussions From The Biosimilar Medicines Conference
    3 Crucial Discussions From The Biosimilar Medicines Conference

    After roughly four years of writing about biosimilars, I can finally say I attended the Annual Biosimilar Medicines Conference. This conference was valuable to get a closer look at Europe as well, not only to see where things are working, but also where they're not.

  •   Modular Bioprocessing Alleviates Drug Manufacturing Woes
    Modular Bioprocessing Alleviates Drug Manufacturing Woes

    Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries.

  • A Common Sense Approach To Sustainability In The Biosimilar Business
    A Common Sense Approach To Sustainability In The Biosimilar Business

    Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.

More From Biosimilar Manufacturing solution center

ABOUT BIOSIMILAR MANUFACTURING

Biosimilars are considered to be low-cost substitutions for pricy, large-molecule biologics. However, biosimilars must meet the same quality, safety, and efficacy as their reference biologic. Manufacturing biosimilars requires a more complicated procedure than that of manufacturing small molecule generics. Companies manufacturing biosimilars are focused on creating a chemical structure that is as close as possible to that of the reference product. Failure rates and operational costs pose a challenge for those companies involved in manufacturing biosimilars compared to those manufacturing small molecule generics.

Small molecule generics are created using the same active pharmaceutical ingredient (API) and, therefore, are chemically identical to that of the originator medicine. The manufacturing process for small molecules comprises only one-fifth of the total in-process tests required to meet Good Manufacturing Practice compared to that of biologic medicines (50 vs. 250 in-process tests). In fact, the manufacturing process for a large molecule is so complex, it cannot be duplicated by two different manufacturers, as the cells used in biologic medicines are unique to the company manufacturing each biologic.

Manufacturing a biologic consists of genetically modifying a cell, which becomes the basis for a cell line used for the production of the necessary protein for the biologic medicine. The protein is then separated from the cells and purified. Biosimilars are created from small alterations to the manufacturing process which creates a molecule that is not identical but closely resembles the reference product. While the differences in the biosimilar molecule might be slight, these changes in the manufacturing process of a biosimilar can affect the efficacy and safety of a biosimilar compared to the reference biologic. Over the past decade, the manufacturing process for proteins has become more standardized and the required technology has become increasingly accessible, leading to reductions in biosimilars production costs. As a result, a greater number of companies have begun manufacturing biosimilars, while reference brand manufacturers are setting their sights on bolstering pipelines and manufacturing biobetters to maintain market share for their soon-to-be-off-patent reference products.