Somatek
Somatek serves companies creating next generation biopharmaceuticals, diagnostics, and research tools. They specialize in cGMP bioprocess development, manufacturing, formulation, and quality control, focusing on gene delivery products, biologics, analytics, outsource management, and regulatory guidance. The company supports research products and collaborates with a diverse client base ranging from large pharmaceutical companies to startups, aiming to accelerate innovation in the biotech industry.
Industries
Nr. of Employees
small (1-50)
Somatek
San Diego, California, United States, North America
Services
cGMP bioprocess development and manufacturing
End-to-end cGMP process development and manufacturing support for biologics, including formulation and quality control to support clinical and commercial supply.
Biologics development (viral vectors, proteins, antibodies, ADCs)
Technical and development support for gene-delivery products and therapeutic proteins including antibodies and antibody–drug conjugates.
Analytical development, qualification, and validation
Assay design, optimization, characterization, qualification, and method validation to support development and regulatory submissions.
Outsourcing management and CMO/CRO project management
Management services for third-party outsourcing including bid preparation, contract negotiation, and end-to-end project coordination with CMOs and CROs.
Regulatory guidance and submission support
Regulatory strategy and support for interactions with FDA and EMA across development stages from pre-IND through BLA/registration.
Process development using advanced bioreactor control systems
Process development services leveraging advanced bioreactor control platforms to enable flexible process definition and small-footprint development workflows.
cGMP bioprocess development and manufacturing
End-to-end cGMP process development and manufacturing support for biologics, including formulation and quality control to support clinical and commercial supply.
Biologics development (viral vectors, proteins, antibodies, ADCs)
Technical and development support for gene-delivery products and therapeutic proteins including antibodies and antibody–drug conjugates.
Analytical development, qualification, and validation
Assay design, optimization, characterization, qualification, and method validation to support development and regulatory submissions.
Outsourcing management and CMO/CRO project management
Management services for third-party outsourcing including bid preparation, contract negotiation, and end-to-end project coordination with CMOs and CROs.
Regulatory guidance and submission support
Regulatory strategy and support for interactions with FDA and EMA across development stages from pre-IND through BLA/registration.
Process development using advanced bioreactor control systems
Process development services leveraging advanced bioreactor control platforms to enable flexible process definition and small-footprint development workflows.
Expertise Areas
- cGMP bioprocessing
- Biologics process and product development
- Downstream processing and filtration
- Analytical assay development and qualification
Key Technologies
- Tangential flow filtration (TFF)
- Ultrafiltration–diafiltration (UFDF)
- Nanofiltration for virus clearance
- Bioreactor process control systems