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    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. BeiGene, a commercial-stage biotechnology company, can attest to these challenges.

  • 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.

  • Converting From ELISA To Biacore SPR Assays
    Converting From ELISA To Biacore SPR Assays

    Biacore SPR assays provide an automated and reproducible real-time determination of active concentrations that can be considered an alternative to traditional ELISA approach. This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR-assay and by doing so, shows how you can get results in less than half the time compared with ELISA.

  • How Well Are Your HCP ELISAs Covered?
    How Well Are Your HCP ELISAs Covered?

    Validating host cell protein ELISAs is an essential part of biologics development. But what makes these coverage assays so vital, and what could we improve? Read how this 2D DIBE approach combines the best of existing methods.

  • Why, Why, Why… ELISA? A Look At The Benchmark HCP Assay
    Why, Why, Why… ELISA? A Look At The Benchmark HCP Assay

    Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA, and how it fits into process development.

  • End-To-End Process For Oncolytic Adenovirus Production
    End-To-End Process For Oncolytic Adenovirus Production

    Oncolytic viruses constitute a new promising therapeutic approach for treatment of cancer. Here’s an example of a scalable, end-to-end process for oncolytic adenovirus production using modern tools and technologies.

  • Adenovirus Production In Single-Use ReadyToProcess WAVE™ 25 Bioreactor System
    Adenovirus Production In Single-Use ReadyToProcess WAVE™ 25 Bioreactor System

    Using rocking bioreactor systems can shorten the seed train prior to inoculation and provide optimized growth conditions for sensitive cells. This study presents a robust production of adenovirus using a rocking bioreactor system.

  • More Efficient Bispecific Antibody Purification With Fewer Steps
    More Efficient Bispecific Antibody Purification With Fewer Steps

    A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.

  • Digital Manufacturing Of Biologics
    Digital Manufacturing Of Biologics

    In addition to an explanation of digital manufacturing, this paper covers how it can improve the productivity and robustness of existing processes and facilities. Gain and understanding of digital biomanufacturing for upstream and downstream processes as well as the technologies that support digital manufacturing of biologics.

  • The New Age Of Digital Biomanufacturing
    The New Age Of Digital Biomanufacturing

    Advances in bioprocess monitoring and analytics, as well as in bioinformatics and computational biology, are changing the way we look at the bioproduction process. This poster explains the drivers of the digital biomanufacturing revolution and how they are steering us towards science-based increased plantwide efficiency, quality, adaptability, and profitability.

  • Optimizing Process Efficiency In Upstream Manufacturing
    Optimizing Process Efficiency In Upstream Manufacturing

    Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency - a key goal for biopharma production.

  • Chasing The Biopharma Market
    Chasing The Biopharma Market

    From new customer bases and vaccines to biosimilars and antibodies: what are the emerging trends and hot topics in biopharma, and how can companies take advantage of them in order to succeed?

  • Speed Biologics To Clinical Trials Faster
    Speed Biologics To Clinical Trials Faster

    If your business strategy doesn’t fully align with your organization’s capabilities in terms of expertise, capacity, and resources, it might be wise to consider outsourcing to a biologics CDMO for speed to market.

  • What Biosimilar Metamorphoses Are In Store For 2019?
    What Biosimilar Metamorphoses Are In Store For 2019?

    In the second of this three-part "Ask the Board" series, Biosimilar Development's editorial board members discuss their predictions on how biosimilar development, market access, commercialization efforts, and regulatory and reimbursement policies will evolve in 2019.

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.