02.01.26 -- 5 FDA Approval Categories In 2025

FROM THE EDITOR

FEATURED EDITORIAL

Unpacking The EU's Mutual Recognition Agreements For Pharma

By Sabine Paris, Ph.D., GMP Compliance Adviser

The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing

By Srihari Rangarajan, Nathan Silverman, Adam Cooper, et al.

INDUSTRY INSIGHTS

How To Increase Success In Topical Drug Development With Automation

MedPharm

Advances In Analytical Method Selection And Technology Transfer

By Srinath Kashi Ranganath, Thermo Fisher Scientific

Formulation Development Of Enterically Protected Spray Dried Dispersions

Pace® Life Sciences

Modernizing Your Way To Success In Cell And Gene Therapy Manufacturing

By James Jardine, MasterControl, Inc.

Toxic Treatments: Controlling Exposure Risks In ADC Manufacturing

Flow Sciences Inc.

Recommended Mixing Technologies For Producing Capsule Shells

By Christine Banaszek, Charles Ross and Son Company

Solving The Inhalation Puzzle: A CDMO's Guide To Dry Powder Development

Lonza

The Rise In Aseptic Manufacturing Solutions With Smaller Footprints

By James Calle, AST

The Importance Of Reliable Mixing In ITC Experiments

By Morgan Ulrich and Calliste Scholl, TA Instruments

Pharma Company Digitizes Paper Logbooks To Increase Data Accessibility

Tulip

Accelerate GMP Certification With Annex 1-Compliant Aseptic Automation

Cytiva

Less Mess, Less Stress, Best Expressed: An Alternative To Spray Drying

By Chris Brough, AustinPx

3D Screen Printing: Enabling A New Generation Of Complex Formulations

Adare Pharma Solutions

Innovations In Pregastric Absorption Drug Delivery And ODTs

Catalent

Filling Syringes With Spray-Dried Powders

3P innovation

Mitigating Early Development Risks

Samsung Biologics

The Evolution Of EAM/CMMS In Pharma Manufacturing

Blue Mountain

Asian Companies Leverage MES At Manufacturing Facilities

Koerber Pharma

Benefits Of Isolator Technology In Fill-Finish

By Sabrina Zirkle, Jubilant HollisterStier

Process Intensification: Your Guide To "Doing More With Less"

Cytiva

Connected Data: A Catalyst For Compliance And Smarter Decision-Making

By Unjulie Bhanot, IDBS UK HQ

Innovative Technology For Developing, Scaling Peptide-Based Therapeutics

Cambrex

Mitigating Powder Flow And Static Issues

Grace Fine Chemical Manufacturing Services

Increasing Manufacturing Workspace Efficiency In Biopharma

By Matt Hicks and General Counsel, Federal Equipment Company

Ensure Quality Control With Innovative Software

Thermo Scientific Product Inspection

Vial Adapter Transfer Device Compatibility With Cell Therapies

West Pharmaceutical Services, Inc.

A Universal Approach For Single Cell Mass Spectrometry Based Proteomics

Tecan

Unlock Robust And Reliable Stability Data With The Right Partner

By Mahesh Koté and Kyle McQueen, SGS

Reflecting On 2025: Innovation And Investment

ROIS

Cis-Targeted Immunotherapies Need Large CDMO Expertise And Flexibility

By Julie Trulson, Ph.D., Asher Biotherapeutics

Unlock The Power Of Efficient Measurement Instrumentations

By Danny Vandeput, Emerson

The Influence Of Economic Factors On Manufacturing

Asahi Kasei Bioprocess

Cleanroom Changes In 2026 For Better Contamination Control

Contec, Inc.

Aseptic Process Design And Simulation Under Annex 1 Guidelines

Cytiva

Tablet Manufacturing Technologies For Solid Drug Formulation

MilliporeSigma

Why Leaders Can't Afford Delays In Document Review

By Nicola Pearson, Ideagen

Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation

Cambrex

Predicting Hepatotoxicity With The Liver-Chip

Emulate

CDMO Audit Coverage: Key Focus Areas And Compliance Objectives

Afton Scientific

Streamline Your Fill And Finish Process Of Ready-To-Use Cartridges

By Chiara Mussoi, Product Manager Cartridge Platform, Stevanato Group

Comparison Of 96-Pin Extraction Device To Rapid Equilibrium Dialysis

By M. James Ross and Olga Shimelis, MilliporeSigma

Antibody-Drug Conjugates: Next Generation Of Targeted Cancer Treatments

Lonza

Supporting The Unique Needs Of Your Sterile Injectable

Pfizer CentreOne