Newsletter | March 7, 2024

03.07.24 -- Cardinal Health Report Examines Milestone Year In Biosimilars


Using Relational Risk Analysis To Control Procedure Failures In The Biopharma And Medical Device Industry

In the biopharma and medical device industries, operating procedures guide virtually every activity and are required for compliance with good manufacturing practices. Minimizing procedure execution failures is critical. To do so, you can use relational risk analysis (ReRA).

New DSCSA Guidance Details Layers Of Verification System Requirements

A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.

A Data-Derived Approach For Selecting Criticality Levels In FMECAs For Cleaning Process Risk Analysis

The ASTM E55 Cleaning Team, in collaboration with F04 Medical Device Committee members, felt that the commonly used three-level criticality system was inadequate for use in a science- and risk-based standard for cleaning process development, validation, and monitoring. This article will provide a detailed discussion of how science-based and data-driven criticality levels were derived, the meaning of each level, and how they can be used for guiding the selection of risk reduction and risk control measures.


Wearable Injectors: An Alternative To Traditional Intravenous Administration

See a quick visual summary of findings from an early feasibility clinical study featuring a 2-5 mL wearable injector with a viscous placebo.

Cell-Based Potency Assay In Functional Characterization Of mAbs

Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be employed.


Alvotech & Teva Announce U.S. Approval Of SIMLANDI (Adalimumab-ryvk) Injection, The First Interchangeable High-Concentration, Citrate-Free Biosimilar To Humira

Charting New Paths: Non-TNFs Evolving In Rheumatoid Arthritis Market

Cardinal Health Annual Research Report Examines Milestone Year In Biosimilars

Biocon Biologics Secures U.S. Market Entry Date For Bmab 1200, A Proposed Biosimilar To Stelara

CGPA And Biosimilars Canada Statement On Proposed Pharmacare Legislation

Henlius Adalimumab Biosimilar Received sNDA Acceptance Notification From The NMPA


Selecting An Affinity Chromatography Resin For Your Antibody