• Fully Single-Use Virus Filtration In Manufacturing – New Concepts And Strategies

    To reduce time to market multipurpose facilities with fully single-use technologies are used which provides highest flexibility to bring the products fast into the market. Investment costs are much lower and in addition also safety aspects are considered in a much better way. These are just some advantages of fully single-use processes. This poster will focus on concepts for creating single-use virus filtrations steps in different manufacturing ways.

  • Protein A Resin Reduction Achieved With Process Transfer From Batch To BioSMB

    A biopharmaceutical manufacturer was looking to reduce the operating costs of existing purification steps with high resin costs. In this case study they review transferring an existing batch chromatography process into a multi column format and then scaling up that process to an continuous perfusion run. The result was a dramatic reduction in protein A resin requirements.

  • Extraction of mRNA From IVT Mixtures With CIMmultus® Oligo dT Column

    The increasing demand for messenger RNA (mRNA) as a therapeutic product requires larger production scales and more efficient extraction techniques. Here the fast and efficient way to purify polyadenylated mRNA using affinity chromatography on the CIMmultus® Oligo dT column is presented.

  • Purification Of mRNA By Affinity Chromatography On CIMmultus® Oligo dT Column

    Increasing demand for messenger RNA (mRNA) as therapeutic product requires efficient and scalable purification methods. In this application note a CIMmultus® Oligo dT, a monolithic stationary phase is used for purification of mRNA from a capping mix of Luc2 RNA. The large channels and convective mass transfer within the stationary phase eliminate shear forces and allow high flow rates, which leads to very short purification times and high recoveries.

  • N-1 Perfusion High Inoculum Fed-Batch For Reduced COGS And Easy Retrofit

    A mid-to-large biopharma wanted to increase productivity 2-3× in their fed-batch facility and and also reduce their current cost of goods (COGS). With one small change in the upstream (USP) seed train, the customer was able to meet their goals.

  • Increased Productivity With Concentrated Fed-Batch

    A large biopharma company wanted to establish a single-use multi-product facility by choosing appropriate upstream processes that can deliver more than 500 kg/year throughput. This case study shows how a concentrated fed-batch process was established, enabling higher productivity and increasing the throughput (up to 4× higher titer than standard fed-batch), providing more flexibility for production runs.

  • A Simple, Three-Step Approach To Optimize The Fed-Batch Process For mAb Production

    We describe a straightforward way to achieve high-performing fed-batch process for a knockout cell line. This workflow improved titers 500% compared with CHO cell culture in basal medium.

  • How Successful CDMO Collaboration Sets The Foundation For Sterile Injectable Product Success

    In the realm of Sterile Injectables, sponsors come in a variety of sizes and with a range of experience levels. The same is true for CDMOs, and the dynamics of these outsourcing relationships have a huge influence on project success. Explore how a small or medium size biotech or pharma company can benefit from the experience and assistance provided by a CDMO.

  • Outlook: Biotech In 2021 & Beyond

    Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.

  • Introducing N-1 Perfusion To Intensify The Seed Train At A Higher Starting Density

    A high-density N-1 seed culture can improve your fed-batch process by allowing you to seed the production (N) bioreactor at a higher starting density or to replace a large N-1 bioreactor.

  • Intensified And Improved Fed-Batch Production Process: High-Density N-1 Perfusion

    The method described here allows you to intensify your fed-batch process through reduced production duration without affecting the growth or titer profile.

  • Intensified Seed Train Strategy For Faster, Cost-Effective Scale-Up Of Biologics Manufacturing

    The biopharmaceutical industry is looking at process intensification as a means to cost-effectively produce monoclonal antibodies (mAbs). This article explores intensified processing of Chinese hamster ovary clones in the seed train of upstream cell cultures to support generation of high-cell-density cell banks and increased production of mAbs.

  • Bioprocess Intensification – Fast, Flexible And Efficient Solutions

    Now that the biopharmaceutical industry has embraced single-use systems, the focus is shifting to process intensification, which has been defined in many ways. This compilation of articles details how Sartorius experts define process intensification and how end users can transition toward continuous processing.

  • Real World Experience: Modular Facilities, Smaller Footprint With Dynamic Perfusion

    Established manufacturers are looking to single-use, flexible solutions when building new facilities or modifying existing operations. Their goal is to increase productivity across different modalities, including difficult-to-express molecules. Read this success story to understand how dynamic perfusion enabled a CDMO to increase throughput dramatically while establishing a multi-modality facility.

  • No, Biologics Are Not Natural Monopolies

    Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. This article, backed up with data, debunks the myth that biologics are natural monopolies.

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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