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
9466 Black Mountain Road, Suite 150, San Diego, CA 92126, United States
Services
End-to-end cGMP process development and manufacturing support for biologics, including formulation and quality control to support clinical and commercial supply.
Technical and development support for gene-delivery products and therapeutic proteins including antibodies and antibody–drug conjugates.
Assay design, optimization, characterization, qualification, and method validation to support development and regulatory submissions.
Management services for third-party outsourcing including bid preparation, contract negotiation, and end-to-end project coordination with CMOs and CROs.
Regulatory strategy and support for interactions with FDA and EMA across development stages from pre-IND through BLA/registration.
Process development services leveraging advanced bioreactor control platforms to enable flexible process definition and small-footprint development workflows.
End-to-end cGMP process development and manufacturing support for biologics, including formulation and quality control to support clinical and commercial supply.
Technical and development support for gene-delivery products and therapeutic proteins including antibodies and antibody–drug conjugates.
Assay design, optimization, characterization, qualification, and method validation to support development and regulatory submissions.
Management services for third-party outsourcing including bid preparation, contract negotiation, and end-to-end project coordination with CMOs and CROs.
Regulatory strategy and support for interactions with FDA and EMA across development stages from pre-IND through BLA/registration.
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
News & Updates
Somatek hosts a casual networking event for the San Diego life sciences community at their facility.
Somatek will attend the 2023 BioProcess International US West conference in San Diego, focusing on accelerating market entry for biologics.
CG Oncology's IPO was successful, with their bladder cancer treatment receiving FDA fast track and breakthrough therapy designations.
FDA approved the first bispecific T-cell engager for small cell carcinoma, a significant advancement in immuno-oncology.
FDA plans to replace animal testing with validated new approach methodologies such as organ-on-a-chip systems and computational modeling.
A majority of older Americans want to know if they have Alzheimer’s before symptoms appear, and they support early treatment options.
Somatek hosts a casual networking event for the San Diego life sciences community at their facility.
Somatek will attend the 2023 BioProcess International US West conference in San Diego, focusing on accelerating market entry for biologics.
CG Oncology's IPO was successful, with their bladder cancer treatment receiving FDA fast track and breakthrough therapy designations.
FDA approved the first bispecific T-cell engager for small cell carcinoma, a significant advancement in immuno-oncology.
FDA plans to replace animal testing with validated new approach methodologies such as organ-on-a-chip systems and computational modeling.
A majority of older Americans want to know if they have Alzheimer’s before symptoms appear, and they support early treatment options.