Newsletter | November 30, 2023

11.30.23 -- Sandoz launches Hyrimoz (adalimumab) High-Concentration Formulation In Europe


Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 1

All drug delivery manufacturing systems undergoing quality improvement projects involve teams to gather many inputs and then to analyze the data. This article, the first in a three-part series, provides an overview and theoretical understanding of measurement system analysis using continuous gage repeatability and reproducibility (R&R) studies.

Best Practices For Use Of Risk Registers In Manufacturing Operations

Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.

Quality Management Evolves From Function To Pharma Culture

Quality management maturity is an important new trend in the biopharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol.


Selecting Container Closure Components: A Data-Driven Approach To CCI

Discover an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.

Imaging Large-Volume Subcutaneous Injections To Inform Clinical Design

New higher volume, higher viscosity pharmaceutical formulations for subcutaneous injection, alternatives to traditional intravenous treatment, enable chronic disease therapy in alternate settings.


Lupin And Amman Pharma Sign Exclusive Licensing And Supply Agreement For Ranibizumab Biosimilar

Sandoz Launches Hyrimoz® (adalimumab) High-Concentration Formulation In Europe, Aiming To Improve Patient Care


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