Formulation Development
FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES
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From Biomarker Data To Proof Of Mechanism
Biomarker values support mechanism only when the decision, analytical plan, and validation are designed as one chain, with expected direction of change and baseline noise defined before sampling.
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Expert Q&A: Navigating Complexity In Modern Small Molecule Development
Small molecules are growing larger, more potent, and more structurally complex while timelines compress. That combination reshapes scale-up, outsourcing relationships, and the criteria for choosing a manufacturing partner.
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A Connected Approach To OSD Development
See how an integrated OSD development strategy can identify risks early, strengthen process understanding and prepare products for scale-up, tech transfer and commercialization.
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Is Your API Right For A Soft Gel Capsule?
Soft gel delivery systems can enhance bioavailability, enable controlled release, support combination dosing, and handle potent compounds while improving stability and patient adherence.
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How A CDMO Overcomes Soft Gel Formulation Challenges
Softgel development demands careful control of shell properties, liquid fills, and stability. Overcoming formulation challenges improves drug delivery, bioavailability, and shelf life.
FORMULATION DEVELOPMENT APPLICATIONS & STUDIES
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Turning A "Brick Dust" Compound Into A Clinically Viable Oral Formulation
Advanced wet milling and particle stabilization improve solubility, enhance bioavailability, and support scalable manufacturing for complex oral drug development programs.
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Creating A New Dosage Form From An Approved Drug For A New Rare Disease
Advancing approved drugs into new indications requires smart formulation, strong quality controls, and regulatory expertise to overcome challenges and accelerate patient access.
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Improved Oligonucleotide LC–MS Performance
Metal surfaces and PFAS-based ion-pair reagents limit oligonucleotide LC-MS. Inert hardware and ion-pair-free separation modes change recovery, resolution, and spectral clarity in ways worth examining.
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Integrated LC/UV And LC/MS Workflows For Impurity And Degradation
Fatty acid-modified GLP-1 peptides carry hydrophobicity and impurity profiles that strain separation. Pairing LC/UV with mass spectrometry exposes degradation and supplier-to-supplier differences.
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LC/MS Characterization Of GLP-1 Receptor Agonist Oligomers
Liraglutide isomers diverge in oligomerization, while unexpected impurities resist routine identification. Pairing fast screening with targeted sequence analysis supports confident impurity assignment.
FORMULATION DEVELOPMENT SOLUTIONS
- Waters Liquid Chromatography And LC-MS Solutions
- Pharma Services: Support From The Idea To Production
- Solutions For Your Oral Dose Challenges
- Accelerate Molecules Through Development With Translational Pharmaceutics®
- High-Purity Analytical Solvents: Consistent Quality For Critical Applicants
- An Organ-Chip Platform That Generates Human-Relevant Data At Scale
- A Rapid Workflow For High‑Resolution Protein Analysis
- Increase Speed, Sensitivity, And Resolution With UPLC Column Technology
- Cell Culture Media For Viral Vector Production
- Small Molecule Drug Substance: API Capabilities
PHARMACEUTICAL AND FORMULATION DEVELOPMENT NEWS
- Lonza Signs Agreement To Acquire US CDMO Network From Merck KGaA, Darmstadt, Germany, And Significantly Expands Its US Presence
- Bracco To Build New Injectable Drug Manufacturing Facility In North Carolina
- Lonza Further Expands Bioconjugation Manufacturing To Support Growing ADC Demand
- ROSS Portable High Shear Mixing System
- Ardena Launches Online Biomarker Catalogue: 228 Markers, One Quote Request
- Meissner Hosts Ribbon Cutting Ceremony For X-Ray Irradiation Services And Breaks Ground On Phase 2 Of Its Athens, Georgia, U.S.A. Campus
- Global Pharma Manufacturing Community Meets In Berlin For PHARMAP 2027
- LGM Pharma Acquires Sannova Analytical, Expanding cGMP Analytical And GLP Bioanalytical Services
- MVIC And Upperton Pharma Solutions Announce Strategic Collaboration
- All-In-One Solution For Continuous Microbial Monitoring Without Production Interruptions