Technical Papers

300 Results

Article on Viral Clearance for Biopharmaceuticals

Article on Viral Clearance for Biopharmaceuticals

Catalent Pharma Solutions | 24-Aug-2015 | Technical / White Paper

Viral clearance studies are mandated prior to entering clinical trials and for commercial launch of biopharmaceuticals.  These studies are a key component...

Glass to plastic: a gas barrier PFS for biologics

Glass to plastic: a gas barrier PFS for biologics

Nemera | 13-Jul-2015 | Research Study

Gas permeability remains a main challenge of plastic prefilled syringes, preventing an increased uptake in some applications. Nemera has developed an innovative...

Elemental Impurities for ICH Q3D, USP, and EP

Elemental Impurities for ICH Q3D, USP, and EP

SGS Life Science Services | 15-Jun-2015 | Technical / White Paper

This white paper describes the risk assessment, implementation, and validation of the new elemental impurity guidelines. In order to meet the new standards...

Maintain Product Integrity with Moisture Protection

Maintain Product Integrity with Moisture Protection

Colorcon Inc. | 01-Jun-2015 | Technical / White Paper

Many active pharmaceutical ingredients and solid oral dosage tablets are sensitive to moisture, potentially resulting in degradation or poor product performance....

Development of a coated ODT formulation

Development of a coated ODT formulation

Roquette Pharma Solutions | 20-Apr-2015 | Case Study

Orally Disintegrating Tablets (ODTs) are patient friendly delivery systems being far more convenient than the traditional “tablet and a glass of water”....

GELITA® RXL technology prevents cross-linking

GELITA® RXL technology prevents cross-linking

Gelita AG | 06-Apr-2015 | Data Sheet

The GELITA Pharmaceutical Competence Team has developed a new technology: GELITA® RXL (Reduced Cross-Linking gelatine) that adds extra value to gelatine...

Amino Acid Analysis According to Ph.Eur 2.2.56

Amino Acid Analysis According to Ph.Eur 2.2.56

SGS Life Science Services | 23-Feb-2015 | Technical / White Paper

Employing spectrophotometry and liquid chromatography quantitation of Ninhydrin-positive substances achieves 0.05% reporting sensitivity as required by...