Newsletter | January 9, 2025

01.09.25 -- AP Biosciences' Approach To Complex Antibody Manufacturing

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Now available on demand! Choosing the right CDMO for antibody development is crucial. The wrong partner can lead to delays and quality issues, while the right one can streamline development and improve commercialization success. Join Outsourced Pharma's expert panel on CDMO selection for biologic drug developers, where experts will discuss qualification processes, partnership management, team and facility compatibility, and how to leverage your CDMO's strategic expertise.

FEATURED EDITORIAL

ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction

This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.

AP Biosciences' Approach To Complex Antibody Manufacturing

The bispecific developer's vice president of antibody discovery, Jhong-Jhe You, digs into the company's approach to purification and analytics.

Survey Findings: How Are IDMP Readiness Efforts Progressing?

ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.

INDUSTRY INSIGHTS

Guide To PUPSIT And Annex 1 In Aseptic Processing

Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.

Improving Bioprocess Monitoring And Control With Multivariate Data Analysis

Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.