Biosimilar Manufacturing solution center
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.
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.