FEATURED EDITORIAL
A Guide To QbD For Small Molecule Drug Product Manufacturing Excellence
By Navneet Kaur, Alkermes, Inc.
Leveraging the quality by design (QbD) approach to achieve manufacturing excellence is game-changing. This article shares QbD principles, benefits, and successful case studies.
CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides
By Kishore Hotha, Ph.D., Dr. Hotha’s Life Sciences LLC
INDUSTRY INSIGHTS
Illuminating The Pathway To Efficient Drug Development For Small Biotechs
By William Powers, Singota Solutions
Fluid Bed And Melt Granulation In Pharmaceutical Manufacturing
By Brian C. Anderson and Daniel Mateo-Ortiz, AbbVie
What Pharma And Biopharma Should Know About Container Closure Integrity
By Martin Gabler and Christian Kolić, Koerber Pharma
Oligonucleotide Synthesis: Scale-Up Made Simple
By Stefan Hyde and Yvonne Duckworth, Asahi Kasei Bioprocess
Finding The Right Aseptic Processing Approach
AST
Tablets And Capsules: Overcoming Similar Obstacles In Production
Natoli Engineering Company, Inc.
The Pain Of Change – Could Suppliers Be Part Of The Cure?
By Matt Cokely, Ecolab Life Sciences
Dynamic Precision Weighing Challenges And Innovations
Mettler-Toledo Product Inspection
Why DSC Testing Is A Critical Step In Developing Biosimilar Drugs
By Calliste Scholl, TA Instruments
The Write Side Of AI: Augmenting Capabilities, Not Replacing Them
By Jenny Minigh, inSeption Group
Patient-Centric Solutions To Optimize Medication Adherence
Catalent
Maximize Lab Productivity Anytime, Anywhere With System Monitoring
Waters Corporation, Informatics & Software Division
Considerations For Large-Scale API Production
MilliporeSigma
Overcoming The Challenges In Fabs And Fc-Fusion Development Programs
Lonza
Revolutionizing Viral Infectious Disease Research And Drug Discovery
Emulate
Five Best Practices To Ensure Quality Active Pharmaceutical Ingredients
Pfizer CentreOne
A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration
Cytiva
Fundamentals Of Real-Time Viable Particle Monitoring: How Does It Work?
By Patrick M. Hutchins, Ph.D., TSI Incorporated
Using Advanced Technologies To Formulate Complex Molecules
Five Of The Most Useful Transformations In Modern Organic Synthesis
By Dr. Paolo Braiuca, Thermo Fisher Scientific Bioproduction
Configurations Replacing Bespoke Packing In Cold Chain Distribution
By Lee Stopher, Peli BioThermal
A Practical Packaging Components Checklist For Emerging Biotechs
By Abigail Hisler, West Pharmaceutical Services, Inc.
Migrating Peptide Mapping Methods With Innovative Technology
By Duanduan Han, Robert E. Birdsall, and Karen Nyholm, Waters Corporation
Soluble Versus Insoluble Expression In Microbial Fermentation
By Nikolay Krumov and Jonas Mueller, Lonza
Maintain Sterility And Ease In CGT Development, Including Cryopreservation
By Troy Ostreng, CPC
Applying Automation To The Manufacture Of Drug Delivery Devices
By Ryan Moran, SMC Ltd.
Rethinking Manufacturing Processes To Identify Green Opportunities
By Geert Schelkens, Ajinomoto Bio-Pharma Services
Why And How To Replace Dye Ingress Test By Deterministic CCIT Methods?
Pfeiffer Vacuum Inc.
The Use Of Cell Therapy Isolators To Reduce Batch Contamination
Dec Group
Six Reasons To Consider HVLD Vs. Vacuum Decay For Pharma Products
By Brian Ball, Nikka Densok USA, Inc.
Chronic Inflammation And The Risk For Alzheimer's Disease
Danaher Life Sciences
The Benefits Of Incorporating Lean Methodologies Into Project Management
By Patrick Hayes, CAI
Converting Spaces For GMP Operations
AES Clean Technology, Inc.
Reducing Wastewater Incineration And Carbon Emissions
By Dr. Niklaus Künzle and Dr. Andreas Sieber, Lonza
Late-Stage Serialization Customization: A Key Differentiator For CDMOs
By Barbara Michaela Schulz, GF
Transforming Quality Processes And Collaboration
Veeva
Blended Learning: An Approach To Operator Training
Better Therapeutic Outcomes From Better Drug Delivery
Celanese
Generics Manufacturing And Changing Equipment Needs
By Justin Kadis, Federal Equipment Company
Extractables And Leachables: Risk Management And Analytical Solutions
By Matthew St. Lawrence, Todd Sprouse, and Erik Feldmann, Ph.D., Cambrex
Mastering Manufacturing Challenges: Lessons From A CDMO's EUA Project
Jubilant HollisterStier
The Fusion-Based, Solvent-Free Process Disrupting Spray Drying
AustinPx
Considerations When Outsourcing Your Packaging Operations
By Yves Massicotte, Ropack Pharma Solutions
Using Zydis ODT To Solve Delivery Challenges For Tolerogenic Vaccines
