Newsletter | October 19, 2023

10.19.23 -- FDA Grants Interchangeable Designation To Pfizer's Biosimilar ABRILADA

FEATURED EDITORIAL

Best Practices For Use Of Risk Registers In Biopharmaceutical 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. This discussion also includes pitfalls to avoid.

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.

Is ‘Human Error’ The Cause Or The Outcome Of GMP Deviations?

Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.

INDUSTRY INSIGHTS

Improve The Injection Experience In Chronic Care

This series of frequently asked questions covers the research and design mindset applied to the development of the BD Neopak XtraFlow solution and the anticipated clinical benefits of 8 mm needles.

Improving Efficiency In Upstream Process Development

Explore the latest trends in cell culture technology, the tools and enablers for scale-up, strategies to accelerate cell line development, media development, raw material characterization, and more.

NEWS HEADLINES

CIMERLI (ranibizumab-eqrn) Sales Exceed 100,000 Doses In First Year Of Launch

FDA Approves TOFIDENCE (tocilizumab-bavi) A Biosimilar Of ACTEMRA Developed By Bio-Thera Solutions

Samsung Bioepis Presents Post-Hoc Analysis Of Phase 3 Clinical Trial For SB15, A Proposed Biosimilar To Eyleaⁱ (Aflibercept), At EURETINA 2023

Biologics & Biosimilars Collective Intelligence Consortium Awarded $1.4M Grant From The FDA

Amneal Adds Two Denosumab Biosimilars To U.S. Pipeline, Expanding Oncology Portfolio

FDA Grants Interchangeable Designation To Pfizer’s Biosimilar ABRILADA

Samsung Bioepis Presents Two Abstracts At EADV 2023 Congress, Highlighting Continuous Dedication In Dermatology

SOLUTIONS

The Journey To Safety Through Viral Clearance

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