Biosimilar Manufacturing

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Proteases may be more expensive up front, but the benefits of cutting out a highly toxic substance quickly add up when disposal and environmental safety costs go down.
Ever Wonder What Running A $50B Capital Facilities Project Feels Like?
Eli Lilly and Company's projects in the U.S. include greenfield sites where little infrastructure exists. Here's how the company's approaching the challenge.
Generative AI Can Write The Code, But Who Builds In The Quality?
Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.
Aseptic Filling By Design: Shaping The Future Of Drug Manufacturing
Modern therapies demand higher sterility assurance and flexible operations. Discover how advanced contamination control, barrier systems, and automation strengthen quality and support faster delivery.
UK's Decentralized Manufacturing Could Be A Revolution; Mind The Risk
Decentralized manufacture will only improve patient outcomes if the pharmaceutical quality system at the control site is strong enough to carry the weight of the network.
All The Ways Global Biopharma Still Grapples With Annex 1
Biopharma companies can't consistently meet Annex 1 expectations. At the heart of the problems, regulators have shifted the burden of proof to manufacturers.
Clearing The Fog On New First Air Visualization Expectations
Assessing first air using standard smoke studies is qualitative in nature, and it's difficult to establish clear criteria. Here is how regulator positions are evolving.
Industry Innovators: APAC's Sharp Advanced Therapeutics Edge
APAC is rapidly advancing its role in the global therapeutics landscape, fueled by faster development models. Learn how this momentum is reshaping expectations for innovation and commercialization.
Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables
A new draft guidance document from ICH, issued jointly with the EMA, adopts the position that the assessment of leachables and extractables requires a holistic framework for risk evaluation.
Where Contamination Control Really Breaks Down In Practice
Contamination control gaps arise when two dynamics merge — when processes become familiar and workloads increase. Here's how to spot them before they spin out of control.
SUS Interchangeability Assessment And Qualification Best Practices
Establishing a robust single-use systems (SUS) interchangeability program can be a pivotal feature of a supply chain resiliency initiative.
Why You Need Spare Parts On-Hand
Unexpected equipment failures can derail timelines and strain budgets. Proactively stocking the right spare parts helps labs minimize downtime, protect productivity, and maintain consistent performance.
Benefits Of Preventive Maintenance
Preventive maintenance keeps bioprocessing operations steady. Discover why routine service is essential for reliability, safety, and long‑term efficiency across modern manufacturing environments.
Enable Predictive Maintenance With IoT Equipment Service Tool
Explore how predictive and prescriptive maintenance reduces downtime, strengthens equipment reliability, and supports smoother bioprocess operations to maintain consistent production performance.
The Importance Of Preventive Maintenance In Academia
Preventive maintenance may be behind the scenes, but it keeps research running smoothly. Explore how proactive equipment care reduces downtime, increases reliability, and supports safety.

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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ABOUT BIOSIMILAR MANUFACTURING

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