Formulation Development
FORMULATION DEVELOPMENT WHITE PAPERS & ARTICLES
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Nitrosamine Risk Management: Your Questions Answered
Navigate nitrosamine impurities with early risk assessments, trace-level analytical testing, and careful excipient evaluation. Learn strategies to strengthen compliance and optimize testing programs.
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Choosing The Right Solid Form
Mastering polymorph screening helps prevent costly reformulation delays. Explore phase-appropriate strategies, experimental methods, and structural informatics for crystal form selection.
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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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Difficult-To-Purify And Difficult-To-Filter Small Molecules
Poor filterability and stubborn impurities often trace back to the same molecular features, which changes how development teams approach scale-up for larger, structurally complex small molecules.
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Choosing The Right CDMO For Substance Development And Manufacturing
Controlled substance programs demand licensing, closed-system custody, and inspection history well beyond GMP. Sponsors weighing partners must test technical depth against compliance infrastructure.
FORMULATION DEVELOPMENT APPLICATIONS & STUDIES
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From Early Development To Commercial Launch: An End-To-End Partnership
Bringing a critical therapy to market takes early coordination. See how strategic planning helped accelerate an oncology therapy from clinical development to patients.
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Selecting The Right Chromatography Strategy
Difficult small molecule purifications rarely yield to one technique. Modeling, fraction mapping, and preparative HPLC each solve a different problem, and the right choice depends on the molecule.
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Optimizing Particle Properties For Difficult Small Molecules
Crystal morphology and unexpected solid-state intermediates often decide whether a difficult small molecule filters, dries, and scales. Thermodynamic stability may not be the right target.
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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.
FORMULATION DEVELOPMENT SOLUTIONS
- MaxPeak Premier Columns For Protein SEC Analysis
- Comprehensive Support For Regulated Laboratories With FlexCHOICE Service Coverage
- Cutting-Edge Data Integration And Analytics Platform
- Increased Productivity Powered By An Automation Workstation
- Potent, Selective Modulators Of Protein Functions
- ADC And Bioconjugation Center Of Excellence
- Predict And Assign Fragment Ions
- Your End-To-End CDMO Partner
- Our Science-Forward Approach To API Development, Manufacturing
- The Device Of Choice For Applications Requiring Higher Yield
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