• What’s The Environmental Impact Of Biopharma Continuous Manufacturing? Part I

    One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.

  • Tuning Intermediate Volumes On Sepax™ C-Pro Cell Processing System

    Discover how we automate the optimizing cell harvesting process and further minimize the potential for cell loss during wash steps.

  • CAPA System Best Practices For GMP Compliance

    A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. This article delves into the pros and cons of autonomous and integrated systems, and shares some overall CAPA best practices. 

  • 3 Strategies For Optimal Oversight Of Your Outsourcing Partner

    Building strong relationships with chosen biopharma outsourcing partners, namely CDMOs and CROs, relies on a solid outsourcing framework. This article discusses three key areas that should be built into your outsourcing framework and agreements.

  • Bioprocessing Sees Continued Improvements In Batch Failure Reductions In 2022

    Bioprocessing is generally doing better than ever in terms of minimizing batch failures. In BioPlan Associates’ 19th Annual Report and Survey on Biopharmaceutical Manufacturing Production and Capacity, we discovered the leading cause of batch failures and more insights.

  • 2022 Outsourcing Trends In Biopharmaceutical Manufacturing

    The continued focus on productivity and efficiency is moving manufacturers to increasingly consider outsourcing activities. Biomanufacturers are spending more, demanding better technologies, and expressing greater optimism. This article shares the trends in outsourced activities, percentages of activities outsourced, outsourcing destinations, and offshoring.

  • Assessing Extractables & Leachables In Parenteral Drug Products

    Therapeutic complexity increases the potential risks associated with chemical composition of materials used for drug packaging. Leachables in drug or biological products are chemical compounds that originate from components that are used to store and deliver medicines. Extractables should be considered as potential leachables.

  • FDA Finds Drug Shortages Are Mostly Caused By Quality Issues

    New FDA guidance on risk management plans (RMPs) to mitigate the potential for drug shortages recommends an RMP for drugs that treat rare diseases and conditions, drugs with no alternatives, sole source products, products with only one API or manufacturing site available, and drugs made in facilities where an Official Action Indicated has been issued.

  • Biopharma In China: The Emerging Global Force Of Domestic Suppliers

    Though multinational corporation vendors have seen double-digit pandemic-related sales increases for bioprocessing supplies in China, the top domestic vendors have posted even higher growth rates. With domestic supplier prices significantly cheaper, quite a few Chinese biopharma companies are shifting their purchase of supplies.

  • Biopharma Partnerships: Key To Filling The Life Sciences Innovation Gap

    The life sciences industry is facing a significant slowdown due to patent expirations. Many organizations have not established a robust enough pipeline to overcome the revenue to be lost. To bridge this innovation gap, pharma CEOs will need to expand their use of alliances, in tandem with bolt-on M&A, as a pipeline booster strategy.

  • Key Considerations For Decarbonizing Your Biotech Facility

    Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.

  • Demonstrating ROI For Increased Digital Plant Maturity

    Cytiva has partnered with the independent software company, Biopharm Services (BPS), to model the costs and associated benefits of increasing digital maturity for monoclonal antibody processes in a biopharma plant utilizing single-use technology.

  • Liposomal And Nanoparticle Technology At Pfizer Melbourne

    Specializing in oncology, anti-infective and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.

  • The Single-use Bioprocessing Bottleneck & Looking Ahead

    Are you asking, What happened to the bags promised for my product? The single-use system bag market had been seeing strains as early as 2018, and COVID-19 made the demand worse. This article looks into the factors contributing to the demand. Normalization of the supply chain may continue to be delayed, but it will eventually even out.

  • Quantitation Of Retrovirus-Like Particles (RVLPs) In CHO Derived Products

    Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.

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.