Creams - particle size and shape | IMG | General topical skin cream | Automated analysis of drug crystals in topicals and creams using the Morphologi G3 automated image analysis system |
Creams - particle size, Zeta potential | DLS / ELS | Encapsulated retinol system, retinol (vitamin A), waxes, anionic and ionic surfactants | Optimizing topical skin care formulations and production |
Creams - particles Chemical Identification | MDRS | General topical skin cream | Component-specific particle characterization of the active components in a pharmaceutical-topical formulations |
Excipients - crystalline/amorphous ratio | XRD | Filler and dilutant: alpha-lactose monohydrate | Crystallinity determination - Quantification of low amounts of amorphous material in a crystalline matrix and vice versa |
Excipients - particle size | IMG | Milled lactose fines (LH210), coarse lactose carrier (LH100), and blended with budesonide | Understanding the properties of dry powder inhaler formulations through combined cascade impaction and automated image analysis measurements |
Excipients and additives - Protein stabilization | ITC / DSC | ProX, Polysorbate-80, and phenol | Applications of Isothermal Titration Calorimetry and Differential Scanning Calorimetry in biopharmaceutical formulation development |
Gels - crystalline particle size and shape | MDRS | Benzoyl peroxide and adapalene in Epiduo gel | Microstructure of crystals in a topical drug product |
Liquids - size distributions in microemulsions | DLS | API, oil surfactant, and alcohol in water | Microemulsion characterization using dynamic light scattering |
Liquids - nanomaterial dose | NTA | Cerium (IV) Oxide, Titanium dioxide nanoparticles | Time-resolved description of nanomaterial dose under relevant biological and environmental conditions |
Manufacturing - materials identification in Quality Control | XRF | General pharmaceuticals | Material identification by FingerPrint |
Manufacturing - trace elements | XRF | Cd, Pb, As, Hg, Co, V, Ni, Tl, Pd, Ir, Rh, Ru, Se, Pt, Mo, Cu, and Cr | Non-destructive elemental analysis of impurities in pharmaceuticals according to ICH Q3D and USP <232> |
Manufacturing - virus stability | DLS | Three adeno-associated virus (AAV) samples | Measuring the concentration of Adeno-Associated Virus (AAV) with multi-angle dynamic light scattering (MADLS) |
Nasal spray - APIs in mixtures | MDRS | Inhalers | Supporting dry powder inhaler formulation development using component-specific particle characterization |
Ointment - particle size and shape | IMG | General ointment | Automation of QC microscope measurements of a pharmaceutical ointment using the Morphologi particle characterization system |
Oral solid dosage - analytical methods review | Various | White paper - review article | Analytical techniques with a place in the oral solid dosage formulation toolkit |
Oral solid dosage - Bioequivalence | MDRS | Painkillers | Confirming the pharmaceutical equivalence of Oral Solid Dose (OSD) products using MDRS and the Morphologi 4-ID |
Oral solid dosage - API particle size | LD | Tablet prepared as a suspension | Determining the particle size of active pharmaceutical ingredient within oral solid dose products using the FPIA-3000 dynamic imaging system |
Pastes - elemental identification | XRF | Toothpaste | Fast toothpaste identification by FingerPrint |
Powders - particle agglomeration | IMG & MDRS | General examples including APIs | Identification of Agglomerates Using Automated Image Analysis |
Powders - particle size | MDRS | Cold remedy formulations compared | Deformulation of a pharmaceutical formulation using the Morphologi ID |
Protein formulations - aggregation | NTA | Protein aggregates | High-resolution sizing and concentration measurements of sub-visible protein aggregates using NTA |
Protein formulations - aggregation | MDRS | Lysozyme (spiked with latex spheres) | Characterization of protein aggregates by Morphologically Directed Raman Spectroscopy |
Protein formulations - antibody interactions | DLS | Monoclonal antibodies (mAb), human serum albumin (HSA), and Immunoglobulin G (IgG) | Using A2 and kD to assess protein interactions in formulations |
Protein formulations - lipid encapsulation, particle size changes | DLS | Lipid polymer | pH and Temperature Responsive Novel Nanoparticles Characterized by Dynamic Light Scattering |
Protein formulations - liquid formulation stability | DSC | Monoclonal antibody, lyophilized | Using Differential Scanning Calorimetry to accelerate liquid formulation development for protein biopharmaceuticals |
Protein formulations - long term stability | DSC | Antibodies and Fc-conjugated proteins | Correlating long term biotherapeutic stability with a fast analytical technique |
Protein formulations - size, aggregation, stability | SEC | Human Ig in phosphate-buffered saline | Protein stability measurements amplified: Combining SEC-MALS and DLS to maximize data output |
Protein formulations - role of stabilizers vs pH | DLS | Recombumin | Formulation stability evaluation using light scattering techniques |
Stabilizers - crystal structure with temperature and humidity | XRD | Trehalose | 2D XRD at non-ambient conditions |
Stabilizers - crystal structure with temperature and humidity | XRD | Trehalose | Temperature- and humidity-controlled XRD |
Protein formulations - stability | DLS | Insulin in phosphate-buffered saline (PBS) buffer | Assessing the self-association and stability of Insulin under varying formulation conditions using Taylor Dispersion Analysis |
Protein formulations - stability in solution | DSC | Proteins | Use of microcalorimetry and its correlation with Size Exclusion Chromatography for rapid screening of the physical stability of large pharmaceutical proteins in solution |
Protein Formulations - stabilizing excipients | DLS | Arginine | Investigating the effects of excipients on the earliest stages of aggregation - Aggregation inhibition by arginine |
Protein formulations - Stabilizers vs temperature | DLS | Recombumin | Using Light Scattering to Study the Thermal Stability of Recombumin |
Protein formulations - viscosity | SEC | Bovine serum albumin in histidine and arginine buffers. | Effect of excipients on protein formulation viscosity |
Sprays - particle size | LD | Hairspray | Characterizing personal and domestic aerosol products using the Malvern Spraytec |
Tablet Coating – particle size | LD | Tablet coating containing Titanium Oxide | Optimizing the processing of pigments using particle size analysis |
Therapeutic Antibodies - characteristics for stability | DSC | Parent and engineered monoclonal antibodies | Engineering monoclonal antibodies to enhance drugability: A case study |
Therapeutic Antibodies - molecular weight | SEC | Antibodies, in phosphate-buffered saline (PBS) | The power of multi-detector SEC in the analysis of antibodies |
Therapeutic Antibodies - molecular weight | SEC | Immunoglobulin G (IgG) | Molecular weight measurements of an antibody using Viscotek SEC-MALS 20 |
Therapeutic Antibodies - purification, elution buffers | DSC | Antibody purification - various elution buffers | Manufacturing biotherapeutic faster using Differential Scanning Calorimetry (DSC) |
Therapeutic Antibodies - stability | DSC | Genetically tailored antibody fragments | Selecting the most stable biotherapeutic antibody using Differential Scanning Calorimetry |
Therapeutic Antibodies - stability in buffer solutions | DSC | Antibodies in a range of buffers | Preformulation and stability studies of biotherapeutics using DSC |