03.01.26 -- The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality

FROM THE EDITOR

FEATURED EDITORIAL

The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality

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

What To Know About — And How To Apply For — FDA's PreCheck Pilot

By Kalie E. Richardson, Hyman, Phelps & McNamara

INDUSTRY INSIGHTS

Cold Chain Logistics And Packaging Considerations For Probiotics

Ropack Pharma Solutions

Why The Latest E2500-25 Standard Revision Demands Immediate Action

CAI

A Direct Path To Annex 1 Compliance With Blow/Fill/Seal Technologies

By Marty Reyes, Weiler Engineering, Inc.

Redefining OSD Development Through Foresight And Innovation

Thermo Fisher Scientific

Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence?

BD Medical - Pharmaceutical Systems

OSD Early Stage: Getting Oral Products Into Clinic Early

Upperton Pharma Solutions

A Pathway For Regulatory Success For Devices In Combination Products

By Lauren Richards, West Pharmaceutical Services, Inc.

5 Benefits Of Leveraging Machine Learning In Your Workflows

By Robert Hughes and Joshua Clark, Grace Fine Chemical Manufacturing Services

Rethinking The Laboratory Information Management System

By Patrick Lemay, Tulip

Critical Factors For Robust Cleanroom Contamination Control

Ecolab Life Sciences

A Powerful Non-Destructive Tool For Tablet Characterization

By Rahul V. Haware, Robert Sedlock, Grant Sedlock, et al., Natoli Engineering Company, Inc.

Antibody-Drug Conjugates – Catalysts For Chemistry

Curia

Beyond Pills: The Rise Of Liquid Suspensions For Complex Formulations

By Gus LaBella, Mikart

Chromatography Resins In Therapeutic Treatment Delivery

Bio-Rad Laboratories, Inc.

Unlocking Pharma Manufacturing With Contextualized Data

Aizon

Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

Lonza

The Role Of CDMOs In Supporting Generic Drug Development

Douglas CDMO

Liquid Phase Peptide Synthesis: Regulatory, Analytical, And QC Perspectives

Cambrex

Monitoring And Determining The Cause Of Antibody Discoloration

By Haichuan Liu, Marcia Santos, Andy Mahan, et al., Danaher Life Sciences

An Introduction To High Voltage Leak Detection (HVLD) Technology

By Brian Ball, Nikka Densok USA, Inc.

Mixing Technology Considerations For The Cannabis And CBD Industries

By Christine Banaszek, Charles Ross and Son Company

All Eyes On X-Ray Inspection For Big Box Retailers

By Mike Pipe, Mettler-Toledo Product Inspection

Rethinking Ethylene Oxide (EO) Sterilization

Mesa Laboratories

Sourcing Pharmaceutical And Industrial Equipment In Auctions

Federal Equipment Company

Analytical Strategies To Address Common Development Challenges

Lonza

Unveiling Key Insights From Latest Survey On Lab Data Management

By Unjulie Bhanot, IDBS UK HQ

Quick Tips For An Easy Protein Extraction

MilliporeSigma

A Comprehensive Guide To Sampling Protocols And Robust CCI Testing

PTI Packaging and Inspection Systems

Closing And Following Up After A CDMO Audit

Afton Scientific

Reimagining API Manufacturing – How To Achieve Smarter Flow Chemistry

Curia

Dismantling, Modification, And Relocation Of A Multi-Glove Isolator System

Esco Lifesciences

Richter BioLogics Drives Efficiency And Compliance With Unified Quality

Veeva

Optimizing CMO Partnerships

SMC Ltd.

Scaling For The GLP-1 Revolution: Meeting Global Injectable Demand

By Miguel Ángel Ortega Sánchez, ROIS

New Approaches To Tailored Release Profiles

Adare Pharma Solutions

A Case Study Of The GLP-1 Receptor Agonist, Semaglutide, In Plasma

By Samantha Ferries, Suraj Dhungana, Robert S. Plumb, et al., Waters Corporation

Sustainability By Design In API Manufacturing

MilliporeSigma

Unlock The Potential Of Autologous CGT Through Digital Transformation

By Madalina Miron, Emerson

Bridging The Gap Between Traditional Models And Human Biology

Emulate

Cleanroom Design Paradigm: Converting Spaces For GMP Operations

AES Cleanroom Technology

Finding The Right Aseptic Processing Approach

AST

Advancing Topical Formulations With Innovative Preclinical Models

MedPharm

Flexibility And Capability In Pre-Filled Syringes: The Future Of PFS

Curia

A Word With Susan Li, Peptide Chief Scientist, Asymchem

Asymchem

Evaluation Of A New Multimodal Anion Exchange Resin

Bio-Rad Laboratories, Inc.

Mastering Challenges In Drug Development Through Technology Transfer

Thermo Fisher Scientific

De-Risking Your Bioconjugate's Path To Clinical Manufacturing

Lonza

Determining The Power Numbers For A Single-Use Mixing System

Cytiva