Formulation Development
FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES
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![GettyImages-2238837244-compliance-meeting-regulation-regulatory]( "Why CMC Continuity Is The Missing Link Between Development And Manufacturing")
Why CMC Continuity Is The Missing Link Between Development And ManufacturingDiscover why CMC continuity is the missing link between development and manufacturing, and how preserving connected product and process knowledge helps reduce handoff risk, accelerate tech transfer, and strengthen manufacturing readiness.
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![paediatric-oral-dose-GettyImages-2251563567]( "Analytical Method Development For Paediatric Oral Dose Products")
Analytical Method Development For Paediatric Oral Dose ProductsThis article explores the key formulation and analytical challenges that pharmaceutical companies face when creating safe, effective, and age-appropriate treatments for paediatric populations.
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![Solubility And Improved Patient Outcomes-GettyImages-2277363545]( "Solubility And Improved Patient Outcomes")
Solubility And Improved Patient OutcomesPoor solubility poses major development challenges. Innovative formulation technologies and careful excipient selection can improve bioavailability and product performance.
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![GettyImages-1417391937-pharmaceutical-spray-drying-with-scientists]( "Overcoming The Obstacles Of Spray-Dried Dispersion Scale-Up")
Overcoming The Obstacles Of Spray-Dried Dispersion Scale-UpSDD scale-up introduces scale-dependent risks that threaten bioavailability, stability, and manufacturability. This white paper details a model-based framework for managing those risks from early feasibility through commercial production.
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![iStock-1248627316-chemistry-beaker-lab-science-experiment]( "Chemoenzymatic N-glycan Conjugation Of Native mAbs Provides Homogeneous, Efficacious ADCs")
Chemoenzymatic N-glycan Conjugation Of Native mAbs Provides Homogeneous, Efficacious ADCsA chemoenzymatic two-stage protocol enables DAR2 ADCs from native, non-engineered mAbs via glycan remodeling at Asn-297 and copper-free click chemistry, with in vivo efficacy outperforming a comparable marketed ADC.
FORMULATION DEVELOPMENT APPLICATIONS & STUDIES
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![Cell and Gene pharma manufacturing bioprocess GettyImages-1166528646]( "Don't Intensify Blindly: Preventing Fouling And Restoring Performance With Targeted Cleaning Of Protein A Resins")
Don't Intensify Blindly: Preventing Fouling And Restoring Performance With Targeted Cleaning Of Protein A ResinsProtein A chromatography intensification can increase productivity, but it may also affect process robustness. Explore key tradeoffs, operational challenges, and practical considerations.
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![GettyImages-899692950-cleanroom-microscopes-scientists-analyze]( "Detect Low-Abundance GLP-1 Impurities With Greater Sensitivity")
Detect Low-Abundance GLP-1 Impurities With Greater SensitivityLow-level impurities can be difficult to resolve using conventional approaches. Discover how a Charged Surface 2.3 µm superficially porous Phenyl-Hexyl column enhances reversed-phase LC-MS analysis.
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![GettyImages-1309780330-HPLC-lab-scientist-chromatography]( "Differentiate Challenging Site-Specific Isomeric Amino Acids")
Differentiate Challenging Site-Specific Isomeric Amino AcidsLearn how high-resolution ion mobility, pre-IMS fragmentation, and product ion analysis can resolve difficult peptide isomers and localize structural differences, supporting confident characterization.
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![Female researcher analyzing scientific samples-GettyImages-2231025177]( "Increase Throughput For Intact Mass Confirmation And Impurity Screening")
Increase Throughput For Intact Mass Confirmation And Impurity ScreeningAccelerate intact mass analysis of GLP-1 analogues with automated purity calculations, sub-ppm mass accuracy, and impurity detection for consistent results in under one minute per sample.
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![quality control, sterile pharmaceutical manufacturing facility-GettyImages-2277115553]( "Integrated QC As A Development Strategy: Reducing Late-Stage Analytical Risk")
Integrated QC As A Development Strategy: Reducing Late-Stage Analytical RiskLearn how early QC integration, proactive analytical risk management, and cross-functional collaboration can improve validation readiness, reduce development surprises, strengthen release testing predictability, and help protect critical clinical manufacturing timelines.
FORMULATION DEVELOPMENT PRODUCTS & SERVICES
Leica M80 Routine Stereo Microscopes
Easily inspect, screen, observe or document. Handle your daily inspection or documentation, work confidently, and stay flexible in times of change. The modular stereo microscopes of the M series from Leica are the right choice for an abundant variety of tasks in life sciences and industrial applications.
The M50, M60, and M80 allow operators to see a large sample overview, work comfortably under the microscope, and capture images of important details easily.
Our comprehensive pharmaceutical development service offering includes new drug development, early stage formulation and analytical development for both highly potent and non-potent drug products.
The Intabio ZT system couples icIEF separation and UV detection with high resolution mass spectrometry on the ZenoTOF 7600 system.
Standalone instrument with touchscreen and built-in sample ports for small volumes and cuvettes
The SpectraMax® QuickDrop™ Micro-Volume Spectrophotometer quantifies very small amounts of DNA, RNA, oligos, and proteins.
Leica EZ4 W Educational stereo microscopes for college and university
Letting minds meet… anywhere.
These stereo microscopes provide a wireless education solution to the science classroom. The integrated 5-megapixel cameras can live-stream HD images to students’ smartphones or tablets. Students can connect to the EZ4 W either through its own internal Wi-Fi signal or through the facilities network. The EZ4 E exclusively uses the facilities network (WLAN or LAN) to allow students to connect to the microscope. This is an ideal solution if you don`t want to add additional Wi-Fi access points to your existing wireless network concept.
The Powder Rheology Accessory expands the DHR’s capabilities to powders, enabling the characterization of behaviors during storage, dispensing, processing, and end-use.
We have developed an innovative portfolio of affinity chromatography resins to help you solve challenges in the downstream process of next-generation antibody therapeutics. These resins are specifically designed for the purification of engineered monoclonal antibody (mAbs) modalities.
FORMULATION DEVELOPMENT SOLUTIONS
- Multi-Mode Microplate Reader
- Single-Use Chromatography System For Scale-Up Flexibility
- Increase Speed, Sensitivity, And Resolution With UPLC Column Technology
- Robust Methods With Fewer Injections
- Protect Your Lab Instruments From Expected Downtime With FlexCHOICE Service Coverage
- A Human-Relevant Liver Model With Minimal Drug Absorption
- Multiparticulates For Modified Release Systems
- High-Purity Analytical Solvents: Consistent Quality For Applicants
- Solid State R&D And Pre-Formulation
- Which Organ-Chip Design Is Right For You?
PHARMACEUTICAL AND FORMULATION DEVELOPMENT NEWS
- Jubilant HollisterStier Announces First FDA Commercial Product Approval For Sterile Fill-Finish Line 3
- Ardena To Attend CPHI Worldwide Milan 2026, Launching Charity Step Challenge "From Molecules To Miles"
- AST Names Industry Veteran Jon Lenihan As Chief Commercial Officer
- JHS And Altoura Selected For BioTools Innovator VANGUARD Level Up-XR Program
- Syntegon Launches New Pilot Scale Tablet Coater For Small Batches
- Cambrex High Point Completes FDA, PMDA And TGA PreApproval Inspections, Advancing Commercial Manufacturing Capabilities
- CleanSpace Names Pharma Industry Veteran Will Knapp Midwest Sales Director
- METTLER TOLEDO Introduces LightningBuild Program For Four-Week Delivery
- Eurofins CDMO Alphora Expands Kilolab And High Potency Development And Manufacturing Capabilities
- Ypsomed Opens Production Site In China