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
Nr. of Employees
small (1-50)
Pyramid Labs
3598 Cadillac Avenue Costa Mesa, CA 92626
Services
Pre-formulation and formulation design for liquid and lyophilized parenteral products, including stabilization strategies for sensitive biologics and integration with packaging and process transfer.
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 GMP production with automated filling lines, packaging, labeling and regulatory support for pre-approval inspections and global distribution.
Formulation and process development for lyophilized products with lab-scale and commercial freeze-dryers and capacity planning for large clinical and commercial vial runs.
Method development, transfer, qualification/validation and routine testing including chromatography, mass-spectrometry detection, physicochemical and microbiological assays to support lot release and stability.
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.
Pre-formulation and formulation design for liquid and lyophilized parenteral products, including stabilization strategies for sensitive biologics and integration with packaging and process transfer.
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 GMP production with automated filling lines, packaging, labeling and regulatory support for pre-approval inspections and global distribution.
Formulation and process development for lyophilized products with lab-scale and commercial freeze-dryers and capacity planning for large clinical and commercial vial runs.
Method development, transfer, qualification/validation and routine testing including chromatography, mass-spectrometry detection, physicochemical and microbiological assays to support lot release and stability.
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
News & Updates
Announcement of CEO appointment and planned expansion/doubling of commercial fill–finish capacity.
Announcement of a growth investment by Audax Private Equity to support company expansion.
Discussion of CDMO responses to client relationship changes and support for emerging modalities.
Announcement of a new high-speed fill–finish line at the Costa Mesa site.
Blog post on trends in autoinjector delivery, the role of formulation and sterile fill–finish in device programs, and market growth projections.
Announcement of CEO appointment and planned expansion/doubling of commercial fill–finish capacity.
Announcement of a growth investment by Audax Private Equity to support company expansion.
Discussion of CDMO responses to client relationship changes and support for emerging modalities.
Announcement of a new high-speed fill–finish line at the Costa Mesa site.
Blog post on trends in autoinjector delivery, the role of formulation and sterile fill–finish in device programs, and market growth projections.