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How AI Is Revolutionizing Quality Management Systems
The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.
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Lean Manufacturing Implementation In Pharmaceutical Injectable Facilities
This comprehensive analysis examines lean manufacturing implementation challenges and evidence-based solutions derived from leading pharmaceutical organizations.
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Seed Train Intensification Using High Cell Density Cryopreservation
Streamline your upstream bioprocessing with seed train intensification. Discover how high cell density cryopreservation reduces scale-up time, boosts consistency, and enhances manufacturing flexibility.
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Cell Retention Technology And Specialized Cell Culture Media
Explore how perfusion technology is transforming upstream bioprocessing by boosting productivity, reducing costs, and enabling process intensification while overcoming cell retention challenges.
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Biotech's Plastic Problem Meets Its Match
Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.
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What Happens When You Refuse To Compromise On Sustainability?
Discover how an empty building shell became a sustainable nanomedicine hub and achieved 47% energy savings and 88% fewer emissions, which sets new standards for innovation in the biologics industry.
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Facts About AAV Producer Cell Lines
Gene therapies are revolutionizing medicine, with AAV vectors leading the way. As production evolves, stable cell lines may replace transient transfection and unlock scalable solutions.
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Minimizing The Impact Of Human Errors Using Relational Risk Analysis
This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.
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The Building Blocks Of A Robust Analytical Assay
Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.
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Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities
In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.
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Balancing Protein A Resin Cost, Performance, And Productivity
Optimizing input parameters like DBC, flow rate, and resin durability is key to boosting productivity in downstream bioprocessing. Discover how to tailor resin choices to meet your specific process requirements.
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AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies
A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.
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Here's What Limits AI's Outlook For Replacing Knowledge Workers
Even after AI developers clean up hallucinations and other short-term issues, a large-scale workforce replacement faces a few intractable obstacles.
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How Much Knowledge Work Can Biopharma Offload To AI? Answer: Not Much
In biomanufacturing, knowledge work and manual work are deeply intertwined. One expert suggests replacing entire workflows with artificial intelligence seems unlikely.
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Non Animal Origin Squalene For High-Risk Applications
Explore an ethical and sustainable alternative to shark-derived squalene that is backed by robust data to deliver identical performance in vaccine formulations without environmental compromise.
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.
BIOSIMILAR DEVELOPMENT NEWS
- Advanz Pharma And Alvotech Receive European Approval For Mynzepli®, Biosimilar To Eylea®
- BioDlink's Bevacizumab Approved For Market Launch In Indonesia, Marking Fourth Consecutive Emerging Market Authorization
- Accord BioPharma Announces Commercial Launch Of IMULDOSA® (ustekinumab-srlf) Prefilled Syringes At Lowest WAC Price Among Branded Biosimilars To STELARA® (ustekinumab)
- MedImpact Offers Low Cost, Unbranded Ustekinumab-aekn Biosimilar To Any Specialty Pharmacy In The US
- BioDlink Accelerates Global Expansion With Bevacizumab Launch In Colombia And Pakistan