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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Advancing Reconstitutable Injectables: Aseptic Powder Filling & Dual Chamber Delivery
Spray-dried powders, gravimetric filling, and dual-chamber syringes are converging into one development pathway for reconstitutable injectables, raising the question of how formulation, filling accuracy, and device design should be evaluated together.
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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.
FORMULATION DEVELOPMENT APPLICATIONS & STUDIES
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Building Confidence In Combination Product Development
Early compatibility testing with realistic placebo models helps mitigate formulation risks, ensuring accurate dosing, predictable injection times, and long-term stability.
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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.
FORMULATION DEVELOPMENT SOLUTIONS
- Upadacitinib API Development For Regulatory Purposes
- A Streamlined Approach For The APC Labeling/Conjugation Of Antibodies
- ACQUITY Premier Analytical Solution
- Accelerate Molecules Through Development With Translational Pharmaceutics®
- Custom Organ-Chip Models For A Wide Variety Of Applications
- Human ADME Studies: Human Metabolism Data For Regulatory Submission
- API Stability Combined With Rapid Disintegration
- LABIO 4.0 Marino Golinelli R&D Pharmaceutical Center
- Is NSA Sabotaging Your Lab's Productivity
- Getting Solid Form Right The First Time