Solutions for
Solutions For Complex Biopharmaceuticals and their characterization
AuriSignum provides a comprehensive solution for biopharmaceuticals for a seamless, high quality, single-stop-shop approach : ranging from assistance in drug discovery, process development, detailed product characterisation and ultimately ending in manufactured product release. Our regulatory expertise, proven competencies, advanced facilities and experienced personnel help speed-up timelines and maximize efficiency to shorten the time-to-clinic and lower development costs.
Partnering with biotech companies at every stage of the development lifecycle of biosimilars
This enables us offer unique solutions to various biotech companies:
Small and medium biotech companies requiring a complete auditable, and compliant product characterization dossier at every regulatory submission.
Biotech companies engaged in clinical studies that require bioanalytical studies.
Biotech companies which are engaged in phase III or post marketing surveillance that often require bioanalysis and immunogenicity studies.
Biotech companies engaged in development of biosimilar products requiring to establish biosimilarity with the innovator product involving head-to-head, simultaneously-carried-out comparisons.
CQA Determination
- Compendial/ Non Compendial Methods Development
- Analyses of Multiple Innovator Product batches
- Establish Critical Quality Attributes and Quality Target Profile for the new Biosimilar Product
Process Development
Pilot Plant Studies
- Release Testing for
- Tox studies
- Developing Release Specification for the new Biosimilar
- Stability indicating method development and validation
Scale-up and Process validation
Analytical Method validation & transfer
- Analytical Method Development (if not available)
- Analytical Method validations
- Analytical Method Transfers
Toxicology Studies
Dossier Submission
- Biosimilariy Establishment
- Product Characterisation
- Stability and Degradation
- Pathways for Biosimilarity
Phase1 PK/PD Studies
- PK and PD related Bioanalytical Method Development
- Method Validation
- Bioanalysis of
- Human samples
Phase III + Immunogenicity
- Efficacy related Bioanalytical
- Method Development
- Method Validation
- Bioanalysis of Human samples
- Immunogenicity related Bioanalytical Method
- Development
- Method Validation
- Bioanalysis of Human samples
Market Authorization
Solutions For Complex Biopharmaceuticals and their characterization
AuriSignum provides a comprehensive solution for biopharmaceuticals for a seamless, high quality, single-stop-shop approach : ranging from assistance in drug discovery, process development, detailed product characterisation and ultimately ending in manufactured product release. Our regulatory expertise, proven competencies, advanced facilities and experienced personnel help speed-up timelines and maximize efficiency to shorten the time-to-clinic and lower development costs.
This enables us offer unique solutions to various biotech companies:
Small and medium biotech companies requiring a complete auditable, and compliant product characterization dossier at every regulatory submission.
Biotech companies engaged in clinical studies that require bioanalytical studies.
Biotech companies which are engaged in phase III or post marketing surveillance that often require bioanalysis and immunogenicity studies.
Biotech companies engaged in development of biosimilar products requiring to establish biosimilarity with the innovator product involving head-to-head, simultaneously-carried-out comparisons.
Partnering with biotech companies at every stage of the development lifecycle of biosimilars
CQA Determination
- Compendial/ Non Compendial Methods Development
- Analyses of Multiple Innovator Product batches
- Establish Critical Quality Attributes and Quality Target Profile for the new Biosimilar Product
Process Development
Pilot Plant Studies
- Release Testing for
- Tox studies
- Developing Release Specification for the new Biosimilar
- Stability indicating method development and validation
Scale-up and Process validation
Analytical Method validation & transfer
- Analytical Method Development (if not available)
- Analytical Method validations
- Analytical Method Transfers
Toxicology Studies
Dossier Submission
- Biosimilariy Establishment
- Product Characterisation
- Stability and Degradation
- Pathways for Biosimilarity
Phase1 PK/PD Studies
- PK and PD related Bioanalytical Method Development
- Method Validation
- Bioanalysis of
- Human samples
Phase III + Immunogenicity
- Efficacy related Bioanalytical
- Method Development
- Method Validation
- Bioanalysis of Human samples
- Immunogenicity related Bioanalytical Method
- Development
- Method Validation
- Bioanalysis of Human samples