-
GMP Plant Uniform Lockers And Procedures: Best Practices
As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.
-
What Time Is Best To Bring My CDMO On Board?
The answer might be sooner than you think and entail more transparency than you're used to.
-
Single Use In Biopharma: Beyond Savings & Sustainability
SUT continues to trend in biopharmaceutical applications, driven largely by environmental and economic considerations. But there’s a lot more to the SUT story, including supply chain and standardization advantages. On April 24 at 11 AM ET, we’re diving into it live with independent SUT expert Paul Priebe and Krystal Biotech VP of Technical Operations Mark Petrich.
-
Tips For Viral Vector Production
Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
-
What Is A Viral Vector?
Review a novel adenovirus production process that offers scalable, single-use equipment-compatible solutions, reducing production time and cross-contamination risks.
-
Simplifying CHO Cell Line Genetic Stability Testing
Here, we describe the use of whole genome sequencing to perform a comprehensive assessment of genetic stability in clonally derived CHO cell banks using the Aptegra™ CHO genetic stability assay.
-
A Single, Comprehensive Method For Genetic Stability Testing
Discover a genetic stability assay that is fully validated to GMP quality standards and outperforms traditional testing methods with its enhanced speed and accuracy.
-
2024 CIO Survey Reveals IT Budgets, AI Priorities For Life Sciences Companies
Clarkston Consulting conducted its third annual Chief Information Officer (CIO) Survey to understand IT budgets of life sciences companies, how AI priorities fit into those budgets, and more.
-
The Smart, Savvy Science Driving Viral Vector Scale-Up
Learn about cutting-edge strategies, including alternatives to plasmid-based transient transfection, aimed at addressing current process challenges and bringing revolutionary treatments to patients in need.
-
Managing Supply Chain Risks Using Relational Risk Analysis
In the bio/pharma and medical device industries, you can easily model, understand, and manage supply chain risks using relational risk analysis. Here's how.
-
Designing Highly Agile Bio/Pharma Manufacturing Facilities
In bio/pharma, agile manufacturing is achieved through multipurpose designs that support a variety of unit operations manipulated and operated as independent yet connected modules.
-
Who The Heck Designed This Biopharm Plant?
The Bozenhardts have seen some absurd, expensive facility design errors in their work. They talk about some of the worst ones here so you can avoid the same mistakes.
-
How Continuous Bioprocessing Is Shaping Modern Biopharma Manufacturing
Continuous processing adoption so far has been slow; however, market research shows demand and capacity will grow significantly over the next four years.
-
A Quality-Led Approach To Drug Production Facility Design
There are important considerations that architects and engineers can miss if they don't include the quality perspective. It's better to involve quality at the outset rather than discover omissions when it's too late.
-
AAV Process Intensification Using High Salt Lysis And Salt Tolerant Endonuclease
In the production of adeno-associated virus (AAV) vectors, cell lysis involves challenges addressed through high salt concentrations and a salt-tolerant endonuclease, enhancing titer and infectivity.
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
- Alvotech Signs U.S. Agreement To Expand Access For Newly Approved High-Concentration Interchangeable Biosimilar To Humira® (adalimumab)
- Alvotech And Teva Announce U.S. FDA Approval Of SELARSDI™ (ustekinumab-aekn), Biosimilar To Stelara® (ustekinumab)
- Fresenius Accelerates Momentum In Its (Bio)Pharma Business And Launches Tyenne, Its Third Approved Biosimilar In The U.S
- Boan Biotech Completes Phase 3 Clinical Trial For Its Aflibercept Intravitreous Injection BA9101 In China, Planning To File A BLA
- MAIWEIJIAN, First Approved Biosimilar Of Denosumab (120mg) In China