Supplier profile
Contact details
Within the Pharma/Biotech Division of Bertin Group (60 people, 8 M turn over in 2007), Ellipse Pharmaceuticals provides SMART Innovation & Pharmaceutical Development Services for New Chemical Entities and Biotech-derived drugs.
Our services include Preformulation and Formulation of new therapeutic actives adapted to the clinical development stage, Generic or Generic Plus formulations, Life Cycle Management strategies, Process troubleshooting and manufacturing technical assistance.
Ellipse Pharmaceuticals has developed specific expertise and know-how in the following: Modified release formulations including Multiple units systems, Parenteral formulations (IR, SR liquid & freeze-dried), micro/nano-emulsion systems, patented formulations for mucosal application.
Our strength is to offer bo ...th a fully integrated package and customized solutions taking advantage of a single project manager as your dedicated contact, a well-equipped formulation platform, a lab offering a large set of analytical techniques, a board of experts covering all aspects of pharmaceutical development.
Bertin Pharma / Biotech Division: The ONE - STOP SHOP for pharmaceutical & biopharmaceutical companies:
PHARMACEUTICAL DEVELOPMENT
-Preformulation
Chemical entities and Protein-based drug including highly potent products
Full API profiling (Physico & chemistry characterization, Caco-2 and MDCK cells , Human blood-brain barrier, BCs classification, Kinetics & Metabolism)
Original approaches for improving solubility of Class 2 molecules (encapsulation, micro and co-micronisation using the Precellys)
-Formulation
Dry, liquid and semi-solid formulations
Screening of the formulation options depending on the API characteristics, the clinical development stage and the IP environment
From lab to pre-pilot scale
-Manufacturing process development & validation
-Technical support for the manufacturing of clinical & pilot batches / Troubleshooting
-Analytical Services
Two platforms respectively dedicated to small molecules and peptides/proteins
Analytical development and validation on the finished dosage forms
Analytical support during formulation development
Stability studies (tailored conditions and ICH)
Quality Control
-Regulatory Affairs
Regulatory strategy, Audits
IND, NDA,IMPD, CTD Module 3
CE Labelling (Medical device)
Follow-up questions from agencies
ADME & IMMUNOGENICITY
-Animal & Human pharmacokinetics
-In vivo & in vitro metabolism profile
-Alternative in vitro models
-Bioanalysis of NECs, proteins & oligonucleotides
-Assessment of immunogenicity
BIOTRANSFORMATION
Generation & production of NCEs or metabolites using natural micro-organisms & recombinant yeast strains over-expressing human CYPs
IMMUNOPHARMACOLOGY & BIOSAFETY
-AIDS, TSE
-Vaccines & Adjuvant
-Inflammation & Immunomitoring
-Allergy & Asthma
BIOMARKERS
-Assay development & validations
-GLP compliant PK-PD studies
-Broad range of EIAs Read more
Our services include Preformulation and Formulation of new therapeutic actives adapted to the clinical development stage, Generic or Generic Plus formulations, Life Cycle Management strategies, Process troubleshooting and manufacturing technical assistance.
Ellipse Pharmaceuticals has developed specific expertise and know-how in the following: Modified release formulations including Multiple units systems, Parenteral formulations (IR, SR liquid & freeze-dried), micro/nano-emulsion systems, patented formulations for mucosal application.
Our strength is to offer bo ...th a fully integrated package and customized solutions taking advantage of a single project manager as your dedicated contact, a well-equipped formulation platform, a lab offering a large set of analytical techniques, a board of experts covering all aspects of pharmaceutical development.
Bertin Pharma / Biotech Division: The ONE - STOP SHOP for pharmaceutical & biopharmaceutical companies:
PHARMACEUTICAL DEVELOPMENT
-Preformulation
Chemical entities and Protein-based drug including highly potent products
Full API profiling (Physico & chemistry characterization, Caco-2 and MDCK cells , Human blood-brain barrier, BCs classification, Kinetics & Metabolism)
Original approaches for improving solubility of Class 2 molecules (encapsulation, micro and co-micronisation using the Precellys)
-Formulation
Dry, liquid and semi-solid formulations
Screening of the formulation options depending on the API characteristics, the clinical development stage and the IP environment
From lab to pre-pilot scale
-Manufacturing process development & validation
-Technical support for the manufacturing of clinical & pilot batches / Troubleshooting
-Analytical Services
Two platforms respectively dedicated to small molecules and peptides/proteins
Analytical development and validation on the finished dosage forms
Analytical support during formulation development
Stability studies (tailored conditions and ICH)
Quality Control
-Regulatory Affairs
Regulatory strategy, Audits
IND, NDA,IMPD, CTD Module 3
CE Labelling (Medical device)
Follow-up questions from agencies
ADME & IMMUNOGENICITY
-Animal & Human pharmacokinetics
-In vivo & in vitro metabolism profile
-Alternative in vitro models
-Bioanalysis of NECs, proteins & oligonucleotides
-Assessment of immunogenicity
BIOTRANSFORMATION
Generation & production of NCEs or metabolites using natural micro-organisms & recombinant yeast strains over-expressing human CYPs
IMMUNOPHARMACOLOGY & BIOSAFETY
-AIDS, TSE
-Vaccines & Adjuvant
-Inflammation & Immunomitoring
-Allergy & Asthma
BIOMARKERS
-Assay development & validations
-GLP compliant PK-PD studies
-Broad range of EIAs Read more
Categorie
- Recherche Pharmaceutique