• Boost Performance With A Chromatography Resin Update

    Although workhouse resins developed in the 1980s are still used in many processes worldwide, you could be missing out on better productivity and performance. Find an answer to the question, "How do I know which modern resin to use in my new projects?"

  • Mechanistic Modeling For Downstream Processing: Digital Twins Are Here To Stay

    Expensive and time-consuming laboratory experiments, iterative empirical optimization, and even statistical methods alone are not the answers to the challenges of the future. Many global biopharma companies are working on establishing digital twins of their upstream or downstream processes.

  • Demystifying Blockchain-Supported Smart Contracts

    Promising increased accuracy, transparency, and security, smart contracts and blockchain technology are the next steps in the evolution of secure data transaction. Companies in the pharmaceutical industry, and their supply chains, will be forced to adapt their operations to keep up with these generational changes in order to competitively deliver services and treatments.

  • Model-Based Control In Continuous Manufacturing of Biotherapeutics

    During continuous processing, automated control techniques coupled with process analytical tools are required to monitor critical quality attributes and implement real-time control decisions to handle deviations. This article is the first in a two-part series examining how model-based control can be effectively implemented in the various unit operations.

  • A Look Into The Future Of Bioprocessing

    The internet of things and robotics are now being implemented in the biopharma industry, which is more conservative due to strong regulations and intrinsically complex processes. Industry experts for process analytical technologies, automation and data analytics share their views on the future of bioprocessing.

  • Simplifying The Bioprocessing 4.0 Journey

    With a practical step-wise approach starting with PAT, plug and play/industry-standard interfaces, data analytics, and improved controls for CPP monitoring, Bioprocessing 4.0 is achievable.

  • Simplify Upstream Process Intensification From PD To Manufacturing

    Process intensification maximizes productivity and flexibility and can be implemented step-wise or end-to-end. Learn how the high throughput Ambr® systems fast-track biopharm perfusion process development saves time and money.

  • The Need For AI/ML In Drug Discovery, Dev, & Clinical Trials

    While an influx of new companies and technologies is spurring innovation in the industry, these startups are increasingly in competition for talent and capital. Although a fairly new area with respect to the use of AI, the drug design and development process is ripe for the application of machine learning and deep learning techniques. 

  • Computerized Systems Validation And Audit Trail Requirements

    A plug-and-play approach can significantly impact how we design, build, and operate biopharma facilities. Yet, innovative developments create industry adoption  challenges. This article summarizes two recently released BioPhorum standards: Plug-And-Play Computerized Systems Validation Strategy and Plug-And-Play Audit Trail Requirements.

  • The Essential Components Of A Sterility Assurance Program

    The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components of a holistic sterility assurance program for an aseptic manufactured product.

  • Analytical Power Tools Open Upstream Bioprocessing Bottlenecks

    Clone selection is a significant upstream bottleneck slowing bench-to-bedside development progress for new mAbbased therapeutics. With mAb-based product development addressing diseases of such massive financial and societal implications, researchers using analytical power tools can reach their goals faster and shorten the bench-to-bedside development path, benefitting both patients and the bottom line.

  • Cell Line Development: Accelerating Antibody Discovery With The Octet® Platform

    Cell line development involves multiple processes. Large numbers of clones are screened and selected on the basis of productivity and stability. An established platform for rapid titer of antibody clones can enable quick selection of high-producing clones.

  • Secure The Cell Therapy Supply Chain From Bench To Bedside

    Here, we consider the challenges and risks associated with the cell therapy cryogenic supply chain and provide considerations for mitigation strategies.

  • FMEA Vs. System Risk Structures (SRS): Which Is More Useful?

    In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?

  • 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations

    The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.

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.