• Capillary Isoelectric Focusing (cIEF) As A Platform Method For The Evaluation Of Monoclonal Antibody Charge Variants

    The determination of charge variants of therapeutic proteins is a regulatory requirement for pharmaceutical companies. This application note demonstrates the suitability of capillary isoelectric focusing (cIEF) to assess the charge heterogeneity of different types of monoclonal antibodies. Our results prove that the developed cIEF method can be used as a platform to obtain unique profiles for different IgGs and effectively resolve their charge variants, with enough sensitivity to identify differences between the innovator and its biosimilar.

  • Impact Of A Chemically Defined Medium For Vero Cells Cultivation And Virus Production For Vaccine Applications

    In the race to create serum-free, chemically defined media, research efforts have focused on identifying the elements required for superior growth performance. This include growth factors, hormones, carrier proteins, lipids, transition metals, vitamins, polyamines, and adhesion factors. This application note describes 4Cell® NutriVero™ Flex 10, a new Vero cell medium that is serum-free, chemically defined, and animal component-free. 4Cell® NutriVero™ Flex 10 delivers performance that matches conventional media with undefined hydrolysate supplementation.

  • A Multi-Scale Approach To CHO Media Benchmarking

    Competitive commercial CHO processes demand a balanced combination of media, process and production clone to achieve optimal performance. The aim of this study was to apply a multi-scale approach to efficiently screen combinations of chemically defined commercial media and various CHO production clones using benchtop bioreactor systems.

  • 4Cell®BHK-21 CD Medium - Adaptation Of BHK-21 Cells To Suspension Using Chemically Defined Medium

    BHK-21 cell strains have been utilized for several years as a platform for veterinary vaccines and recombinant protein manufacturing. However, these cells are anchorage-dependent, requiring the use of dissociation agents that slow and are traumatic for cells while also creating scale-up limitations. In this study, we successfully adapted anchorage serum-dependent BHK-21 cells to suspension in a chemically defined (CD), serum-free, Sartorius medium.

  • Development And Qualification Of A Complex Potency ELISA

    PD-1 has an important role in preventing autoimmune diseases but can also prevent the immune system from killing cancer cells. PD-1, which can be found on T cells and some B cells, normally interacts with its two ligands PD-L1 and PD-L2, found on antigen-presenting cells and tumor cells. Many new therapies are targeting the PD-1 pathway to boost the immune response to cancer cells. Current assays used to measure the activity of anti-PD-1 or anti-PD-L1 antibodies can be highly variable due to their reliance on primary cells and complex assay protocols. One method to demonstrate the activity of anti PD-1 molecules using a functionally relevant but less variable method is using a potency ELISA.

  • Accelerating cGMP Production Using Rapid Tech Transfer

    The result of a recent partnership between Cytiva and Teva Pharmaceuticals is evidence that a successful tech transfer is possible only with effective communication, diligent project management, and a wide range of expertise.

  • Bayer Evaluates Fibro For Scalable Single-Use mAb Purification

    Learn how Bayer evaluated Fibro PrismA chromatography to determine its potential as a true single-use mAb capture technology. They assessed scalability from lab- to process-scale tracking pressure drop, step recovery, purity, and eluate volumes across multiple cycles. Read the outcome here.

  • Blazar™ Platform: Rodent Virus Panel From The BioReliance® Portfolio

    Did you know about the alternative rapid method for in vivo MAP/HAP/RAP testing? Download our tech note Blazar™ Platform: Rodent Virus Panel From The BioReliance® Portfolio to learn more about our novel degenerate PCR assay designed for the detection of a broad range of adventitious agents.

  • Product Characterization: Reveal Your Molecule Earlier, Faster, And With Accuracy

    Choosing a partner to support your product characterization needs can streamline your drug development program and create efficiencies in moving from concept to clinic. Danny Galbraith, PhD, head of product characterization and new services for MilliporeSigma’s BioReliance® services, answers key questions.

  • Improve Bioprocessing Efficiency With A Standardized Automation Platform

    Designed specifically for the biomanufacturing industry, Cytiva's Figurate automation is a portfolio of automation platform solutions powered by the reliability of Emerson’s DeltaV.

  • High-Quality Chromatography System Meets Predesigned DeltaV For Integrated Manufacturing

    Cytiva’s pre-defined automation solution, Figurate™️, is now available as a turnkey solution by combining our industry-leading ÄKTA™️ process chromatography system with the reliability of the DeltaV DCS platform.

  • Achieving Business Continuity In Pharma During COVID-19 Restrictions

    To ensure business continuity during COVID-19 restrictions, we developed a virtual factory acceptance testing solution that allowed SaudiVax to advance their manufacturing plan.

  • The BPCIA And Declaratory Judgment: The Real Dance Partners?

    In theory, the initial exchange process in the first phase of litigation is intended to whittle down the number of patents and initiate resolution of any disputes during FDA review of the aBLA. However, despite its high-minded objectives, litigation under the BPCIA has proven less harmonious than planned. 

  • The Biosimilar Leadership Playbook: 5 Tips For Success

    In the next five to 10 years, what will define a leader in the biosimilar space? Which skills will be the most important to long-term growth in the biosimilar space? Here McKinsey & Co.'s Jorge Santos da Silva shares five specific best practices emerging for any company looking to be — or remain — a leader in the biosimilar space. 

  • The Opportunities & Challenges Of India’s Biologics Market

    Biosimilar drugs, due to their affordability, can play an important role and allow the Indian government to have a better healthcare system. However, as issues remain on the regulatory and manufacturing sides, India needs to see strong improvements to compete and appear as an important hub nationally and internationally.

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.

 

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