Yale Pharmaceutical Research Institute

Yale Pharmaceutical Research Institute, Inc. USA

Formulation and Process Development

Formulation of non-sterile drug products; solids, semi-solids and liquids
Excipient compatibility studies
Excipient selection and ratio determination
Immediate release dosage form development
Modified and sustained release dosage form development
Brand extension formulation development
Dosage form specification development
Blending, drying, granulation and coating development
Manufacturing process optimization
Drug product specification development
Protein and peptide liquid formulation
Schedule II - IV drug product development
DEA Approved

Formulation Evaluation

Content uniformity evaluation
Dissolution testing
Stability assessment
In-vitro bioequivalence determination
Powder flow determination
Compressibility evaluation
Disintegration testing
Friability testing
Tap density testing

Analytical Services

Dissolution testing
Stability testing
Purity testing
Impurity identification
Particle size determination
Compatibility testing
Solubility screening
Hygroscopicity studies
Bio-analytic methods development and validation
Methods qualification and validation
Protein and peptide based characterization
Chromatography and electrophoresis
Controlled drug substances testing (C II - C V)

Clinical Manufacturing

cGMP manufacturing through phase I, II & III
Dosage form preparation and blinding
Open and blinded clinical packaging and labeling
Semi-automated overencapsulation
Granulation, tableting, encapsulation and coating
Schedule II - V control drug manufacturing

Biotechnology Services

Protein preformulation and formulation development
ICH compliant stability studies
Protein characterization - chromatographic and
electrophoresis separation, peptide mapping, isoelectric(IEF)
focusing, SDS Page, Western blot and amino acid analysis
Bioanalytical methods development and validation
Methods qualification and validation
cGMP release

Regulatory Support

SUPAC applications
ICH interpretations
Chemistry, manufacturing and control section preparation for IND, NDA,ANDA submissions
Product development strategies