Where Do We Stand On Adopting Continuous Manufacturing For Biologics?
Continuous manufacturing offers productivity and cost-saving benefits among other things, but technical and regulatory challenges have slowed uptake. Speeding up adoption will require innovation and knowledge sharing within the industry and regulatory support from the FDA.
Longhorn’s Path To A Universal Influenza Vaccine
Thanks to the long-term planning of one biopharma family and some help from the U.S. Army, a universal influenza vaccine is coming soon to a clinical trial near you.
5 Steps To Eliminate Weak Links In Your Data Governance
Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
Create The Correct Checklist To Land The Best CDMO
When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static. Flexible enough to meet the needs of the project and the personnel, this spec will help you create frameworks, master service agreements, and quality agreements for best oversight of your supplier.
Boost LNP Drug Potency With Optimized Delivery Formulations
Lipid nanoparticles (LNPs) function as a drug delivery system (DDS) for nucleic acids. Learn about biomedical applications of LNPs, anatomy of LNPs, formulation optimization, and LNP safety.
Genomic Medicine Drug Discovery And Screening, A Digital Era For RNA-LNP Therapeutics
Learn about the key stages of drug discovery and screening along with how to overcome key bottlenecks in screening mRNA-LNPs to rapidly develop genomic medicines.
1 Year Out, Where Do We Stand On DSCSA Implementation?
This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.
Generating A Robust Host Cell Line For A Cell Line Development Platform
Learn how cell performance within the context of the cell line development workflow was confirmed with the successful isolation of stable, high-producing clones from three model monoclonal antibodies.
Frequent Deficiencies In GMP Inspections, Part 1
It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.
Bringing Allogeneic Cell Therapy To Patient Care
Bringing allogeneic cell therapy to patient care will require flexible, closed, and automated solutions to support the treatment options and increasing scale of the industry.
CDMO Selection In Our Post-COVID World
In a post-pandemic world, we need to explore a broader view of our new reality. This article shares some of the concepts currently playing out in bio/pharmaceutical outsourcing that will impact your CDMO selection strategy. Additional discussion touches on how new outsourcing players will fit in and the path forward.
Standardization And Flexibility In Aseptic Filling
Aseptic filling has changed. High-speed machines designed for a single format are no longer suitable. Learn how aseptic filling workcells provide flexibility at the core of a standardized system.
Jump-Start Your Next CDMO Outsourcing Project With This Checklist
Why does it take so much time between awarding a CDMO contract and initiating of the first activities at the CDMO? Once a project is granted, there are activities that you as the sponsor company can perform before, at, and after the traditional kickoff meeting for best success.
Higher Order Structure Of Proteins By Circular Dichroism Spectroscopy
Learn more about the analytical development for mAbs and recombinant proteins
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.