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A Look At Pharmaceutical Inspection Machine Advanced Technologies
Pharma and biotech companies are increasingly using inspection machines with advanced technologies, such as x-ray inspection, robotics, and more, to help them get ahead of the competition.
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Automating Digital Twins Implementation In Downstream Bioprocessing
One researcher describes a case study in which they simply pressed play on a set of six pre-programmed experiments and returned hours later to a complete data set.
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Introduction To Tangential Flow Filtration
Tangential flow filtration (TFF) is a rapid, efficient method for separating and purifying biomolecules. Learn about TFF, typical TFF system configurations, ultrafiltration fundamentals, applications, system selection considerations, and more.
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Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide
Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.
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A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.
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These Were FDA's Top Citation Issues For Data Quality In 2024
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.
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Top 10 Data Auditor Statistical Software Requests
Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.
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Computer Systems Validation Pitfalls, Part 4: Inattention To Details
The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.
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How 'Explainable ML' Can Improve Process Performance
In a case study, chromatography process data converted into "images" equipped artificial intelligence to help manage dynamic binding capacity degradation.
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Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data
The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.
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Suffering High Protein Sieving Losses? It Might Be The Buffer
New research shows that a common buffer used during diafiltration and ultrafiltration was at the heart of sieving losses, and using an alternative dramatically improved retention.
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Developing ADCs? Here's A Refresher On HPAPI Occupational Health Risk Mitigation
API payloads used in antibody-drug conjugates are some of the most potent substances in biopharma, so it's important to protect workers who handle them.
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A Transient Cell Line To Produce rAAV With Low-Level hcDNA Encapsidation
Discover the ability of a novel HEK293 suspension cell line for efficient and scalable rAAV production across various serotypes with low encapsidated host cell DNA levels.
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Toward A Gene Therapy Platform: What's The Best Format Of Tangential Flow Filtration (TFF)?
Evaluate TFF formats (hollow fiber and flat sheet) and membrane chemistries for AAv gene therapy processing, assessing performance, scalability, economy, and closed processing options.
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Solvent-Free Purification Of D84-mer Oligonucleotide Using Capto™ PlasmidSelect Resin
Discover a solvent-free process using Capto PlasmidSelect and Capto Q ImpRes resins. They enable high-purity, scalable purification of long oligonucleotides, achieving more than 95% of full-length product purity.
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
- Dr. Reddy's Enters Into Collaboration With Henlius For Commercialization Of HLX15 (daratumumab), A Biosimilar Candidate To Darzalex & Darzalex Faspro In The U.S., And Europe
- US FDA Accepts Biologics License Application (BLA) For HLX11, Biosimilar Candidate Of Perjeta (pertuzumab)
- U.S. FDA Approves Celltrion's AVTOZMA® (tocilizumab-anoh), A Biosimilar To ACTEMRA®
- Kashiv Biosciences Announces Successful Phase 1 Results For Abatacept Biosimilar Candidate, KSHB002
- Alvotech And Teva Announce Filing Acceptance Of U.S. Biologics License Applications For AVT05, A Proposed Biosimilar To Simponi® And Simponi Aria® (golimumab)