• Cross Flow Filtration Method Handbook
    Cross Flow Filtration Method Handbook

    This handbook gives a general introduction to the principles and applications of cross flow filtration using systems and filters from GE.

  • Optimizing the Flexural Strength of Bioprocess Film
    Optimizing the Flexural Strength of Bioprocess Film

    This poster focuses on how the resin selection and architecture of a bioprocess film can be optimized to maintain critical performance attributes, such as container integrity and gas barrier properties, under the significant forces during bulk liquid transportation and WAVE Bioreactor™ system applications.

  • CDMO Horror Stories And How To Avoid Them
    CDMO Horror Stories And How To Avoid Them

    Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.

  • Insights And Tips When Addressing Bioburden Challenges
    Insights And Tips When Addressing Bioburden Challenges

    This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

  • Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing
    Bioburden: Addressing Microbial Contamination In Downstream Bioprocessing

    White paper on the risks related to bioburden downstream processing and the solutions available to mitigate these risks. Topics covered include improvements in raw material quality, equipment design, chromatography resin properties, and ways of working.

  • Perfusion – Do’s And Don’ts To Cut Production Costs, Increase Efficiency
    Perfusion – Do’s And Don’ts To Cut Production Costs, Increase Efficiency

    Setting up a perfusion process is complex, and getting the best out of it requires an awareness of the do’s and don'ts of the approach.  Design of experiment (DoE) and quality by design (QbD) approaches help the development of a production process that is both cost-effective and high quality.

  • Batch And Fed Batch Culture — Practical Steps For Better Results
    Batch And Fed Batch Culture — Practical Steps For Better Results

    Design of Experiments (DoE) mathematical models can help create the perfect environment for batch and fed batch cultures. Understanding the different criteria  and their interactions with each other can be a key differentiator in the race to get your drug to market. 

  • Fermentation And Cell Culture: Bringing The Basics To The Fore
    Fermentation And Cell Culture: Bringing The Basics To The Fore

    Fermentation and cell culture can be carried out in batch or continuous processes.  Reminding ourselves of the basics is vital for the development of more cost-effective and efficient biotech production processes. This article reviews those basics to understand the methods best suited for your development.

  • Practical Guidelines For Lab-Scale Processing In Volumes <50L
    Practical Guidelines For Lab-Scale Processing In Volumes <50L

    The understanding of lab-scale processing, from cell and media type to bioreactor size and scale-up, is a vital part of its development. This article reviews the key steps and considerations to aid in developing the process while keeping costs down.

  • Plant-Based Biosimilar Development Takes Root In Brazil
    Plant-Based Biosimilar Development Takes Root In Brazil

    In June 2017, Canadian company PlantForm announced it was beginning construction for a pilot biologics and biosimilar manufacturing facility in Brazil. Given Brazil’s ongoing efforts to establish a local biotechnology industry, I reached out to learn more about PlantForm’s progress in navigating the regulatory landscape to bring its biosimilars closer to market.

  • Building Thailand’s Biosimilar Industry From The Ground Up
    Building Thailand’s Biosimilar Industry From The Ground Up

    As the first of this two-part article revealed, the biosimilar market has undergone several revolutions since the release of the Thai FDA’s biosimilar guidelines in 2013. During our tour of Siam’s facilities, the company’s managing director, Songpon Deechongkit, Ph.D., shared the company’s history, overall biosimilar strategy, and some of the pros and cons of being the first and only biosimilar company in Thailand.

  • How To Rapidly Create Single-Use Biomanufacturing Capacity
    How To Rapidly Create Single-Use Biomanufacturing Capacity

    To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.

  • Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame
    Behind Samsung Bioepis’ 5-Year Rise To Biosimilar Fame

    Samsung Bioepis celebrated its fifth anniversary in February 2017. I met with Paul Song, VP at Samsung Bioepis, to learn more about the company's motto, "Process innovation," which is credited for the company's swift rise to leadership in the European market.

  • 3 Notable Trends In Amgen’s 2017 Biosimilar Report
    3 Notable Trends In Amgen’s 2017 Biosimilar Report

    The 2017 Amgen "Trends in Biosimilars" report called attention to a few trends that align with what I’ve been observing within the industry that manufacturers, payers, and prescribers should expect for the year (and years) ahead.

  • Celltrion: Data Transparency Imperative For Biosimilar Success
    Celltrion: Data Transparency Imperative For Biosimilar Success

    Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”

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.