Pyramid Labs
Contract development and manufacturing organization (CDMO) focused on parenteral drug product development and GMP sterile manufacturing. Offers formulation and process development for liquid and lyophilized products, aseptic fill–finish for vials and prefilled syringes, analytical/QC testing, stability programs, temperature-controlled storage and regulatory support from clinical through commercial supply. Operates an FDA-registered cGMP facility in Costa Mesa, CA with multi-scale lyophilizers, automated filling lines and continuous environmental/process monitoring.
Industries
N/A
Services
Formulation & Development
Pre-formulation and formulation design for liquid and lyophilized parenteral products, including stabilization strategies for sensitive biologics and integration with packaging and process transfer.
Clinical Manufacturing
GMP aseptic fill–finish for clinical supply including low-volume aseptic fills, vial and syringe filling, clinical-scale lyophilization, packaging and controlled distribution to clinical sites.
Commercial Manufacturing
Commercial GMP production with automated filling lines, packaging, labeling and regulatory support for pre-approval inspections and global distribution.
Lyophilization Services
Formulation and process development for lyophilized products with lab-scale and commercial freeze-dryers and capacity planning for large clinical and commercial vial runs.
Analytical Services & QC Testing
Method development, transfer, qualification/validation and routine testing including chromatography, mass-spectrometry detection, physicochemical and microbiological assays to support lot release and stability.
Stability Studies
Long-term, accelerated and in-use stability programs executed under ICH conditions with dedicated controlled chambers, continuous monitoring and validated handling procedures to support regulatory filings.
Formulation & Development
Pre-formulation and formulation design for liquid and lyophilized parenteral products, including stabilization strategies for sensitive biologics and integration with packaging and process transfer.
Clinical Manufacturing
GMP aseptic fill–finish for clinical supply including low-volume aseptic fills, vial and syringe filling, clinical-scale lyophilization, packaging and controlled distribution to clinical sites.
Commercial Manufacturing
Commercial GMP production with automated filling lines, packaging, labeling and regulatory support for pre-approval inspections and global distribution.
Lyophilization Services
Formulation and process development for lyophilized products with lab-scale and commercial freeze-dryers and capacity planning for large clinical and commercial vial runs.
Analytical Services & QC Testing
Method development, transfer, qualification/validation and routine testing including chromatography, mass-spectrometry detection, physicochemical and microbiological assays to support lot release and stability.
Stability Studies
Long-term, accelerated and in-use stability programs executed under ICH conditions with dedicated controlled chambers, continuous monitoring and validated handling procedures to support regulatory filings.
Expertise Areas
- Parenteral drug formulation and stability
- Lyophilization process development and manufacturing
- Aseptic fill–finish for vials and prefilled syringes
- Analytical method development and QC testing
Key Technologies
- Lyophilization (freeze-drying) — lab to commercial scale
- Aseptic filling and syringe stoppering systems
- High-performance liquid chromatography (HPLC/UPLC)
- Mass spectrometry detection