You Are Never Too Small To Think Big!
Your automation platform can expand with your business if you consider design choices in the initial stages. Early platform design choices can greatly affect speed to market and regulatory compliance.
Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?
This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.
Business Continuity Program Helps Maintain Operations In The Face Of Crisis
Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.
Automated High Throughput mAb Purification Using Fibro Technology
Biomanufacturing is trending towards higher numbers of monoclonal antibody (mAb) projects and smaller batch sizes, with production of most mAbs below 100 kg/yr. These trends are fueling demands to screen more clones faster and improve the efficiency of process development (PD). Read how the Fibro PrismA unit provides a time advantage with comparable recovery and product quality attributes to resin-based column.
Standardization Is Key To Building A Successful Global Business Strategy
Standardized approaches to biomanufacturing can lower costs, improve outcomes and alter the landscape of the global pharmaceutical market.
Increasing Productivity In Hydrophobic Interaction Chromatography
In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.
Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up
In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.
Securing Today’s Biomanufacturing Supply Chain Using Transformative Supply
Managing today’s supply chain complexity begins by transforming historically transactional relationships to those that drive suppliers to value-added status, working toward shared customer goals.
Fresenius Kabi: The Quest For More Efficient Biosimilar R&D
Following the news of Fresenius Kabi’s new biosimilar R&D lab, I reached out to one executive to discuss the current challenges in biosimilar R&D, including maintaining the delicate balance between biosimilar R&D and commercial teams as Fresenius Kabi prepares for a long future in the biosimilar space.
A Biopharma Year In Review — And A Look Ahead To 2020
The industry has shown surprising resilience and consistency, emerging relatively unscathed from the recession at the beginning of the past decade. Capacity and expansion were relatively unaffected and continue to draw investors seeking healthy returns and a recession-resistant risk profile.
Biosimilars: Not Just Big Pharma’s Playground
In addition to discussing past challenges, two experts from NeuClone shared insights into the critical analytical, manufacturing, and clinical considerations that are important to make for any company — but especially for smaller companies — when developing biosimilars.
EMA Update: What Challenges Are Biosimilars Bringing To The Table?
One EMA regulator brought up several points at a recent conference that stood out, either as bright spots to boost industry morale, or that emphasized where the industry needs to focus its energy to pave the way for future regulatory reform.
Can You Trust A Machine For Downstream Bioprocess Buffer Preparation?
Is automated buffer preparation a solution to the dilemma of balancing increased production capacity against limited footprint expansion alternatives?
Sterile Injectable Outsourcing Trends: What Biosimilar Developers Must Know
Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.
The Need For Enhanced Control Strategies In Biopharma Production
Biologicals are the next great step for the pharmaceutical industries. The double-edged sword is that, as the molecules become more and more complex, our need for control and understanding becomes greater.
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.