Newsletter | December 16, 2025

12.16.25 -- Top 10 Of 2025

TOP 10 FROM THE EDITOR

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

CDMOs Should Stop Stringing Biotechs Along

Tech Transfer 2025 – A High-Stakes Game Of Trust

Supporting The Next Generation Of ADCs

How Lumen Is Putting The "Farm" In Biopharma

On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing

The Safety Potential Of Conditionally Active Biologics

Unlocking The Pharmacological Potential Of Antibodies

On The Ground At BPI: Industry Reflections With Carl Schoellhammer, Ph.D.

10.

Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

TOP 10 GUEST COLUMNS

FDA Report Details FY24 Inspections, Shows Big Uptick In Key Countries

By John W. Claud and Mark I. Schwartz, Hyman, Phelps, & McNamara

Report: Nearly 40% Of Biomanufacturers Eyeing Continuous Processing

By Yasmin Timol, BioPlan Associates

Why FDA's Tough Talk On Foreign Inspections Is More Bark, Less Bite

By John W. Claud and Robert A. Dormer — Hyman, Phelps, & McNamara

What Did ICH Q14 Miss On Analytical Method Validation?

By Joachim Ermer, Ph.D., GMP Compliance Adviser

August 2025 — CDMO Opportunities And Threats Report

By GlobalData

How To Grow CHO Cells Without Cysteine, Tyrosine Feeds

A conversation with Bhanu Chandra Mulukutla, Pfizer

How Modeling Predicts Bottlenecks In Takeda's Multimodal Facilities

A conversation with Minhazuddin Mohammed, Takeda

How AI Is Revolutionizing Quality Management Systems

By Stephanie Gaulding, CQA, CGP, managing director, Pharmatech Associates

Unpacking Pfizer's Advanced Process Control Platform For Upstream Ops

A conversation with Shu Yang, Ph.D., and Edwin Shen, Ph.D. — Pfizer

10.

Blood Plasma Fractionation: Engineering And Facility Design For The Future Of Biotherapeutics

By Sanjeev Kumar, NIRAS A/S, Denmark

TOP 10 INDUSTRY INSIGHTS

Process Analytical Technology In The ADC Bioconjugation Process

By Haowei Song, Yiyi Li, Kim Nguyen, Jake Spikes, Mary Ramisetty, Gang Yao, and Lisa MacDermott, MilliporeSigma

CQAs: Their Importance & Limitations In Product & Process Development

By Katrina Adlerz, RoosterBio

What Is A P&ID And How Can I Use It To Understand My Bioreactor Better?

By Valentina Haag, INFORS HT

Optimizing Bioprocesses Using Functional DOE

By Seongjin Kim, Samsung Biologics

5 Biologics Conferences You Won't Want To Miss In 2025

By NanoTemper Technologies, Inc.

Compressed Gas Risk Assessment: A Significant Step In Your CCS

By Particle Measuring Systems

Cell Culture Media Change Protocol

By Corning Life Sciences

Guide To PUPSIT And Annex 1 In Aseptic Processing

By Cytiva

5 Things To Know About The FDA's Shift From Animal Testing

By Abzena

10.

Early Preclinical Development: A Successful Transition To cGMP Manufacturing

By Lonza