Clinical Manufacturing
For over 24 years, Pyramid Labs has supported the development and manufacturing of clinical drug products. Our expert team has successfully guided multiple clients through the approval process, unlocking the full potential of their programs. We are your trusted CDMO partner for comprehensive aseptic fill-finish services for both vials and syringes.
OUR CAPABILITIES
Full-Service Clinical Manufacturing
We offer sterile aseptic manufacturing services for clinical products, including formulation, lyophilization, and filling into both vials and syringes. Our manufacturing, quality and regulatory teams have extensive experience supporting clients through all regulatory phases.
- Vial Filling for 2 mL-20 mL vial sizes
- Syringe Filling for .5 mL-3 mL syringe sizes
- Hypak™ filling and stoppering system enables volumes <1-100+ liters
- Clinical freeze dryer for lyophilization in batches of up to 7,000 vials
- Packaging & Labeling
- Storage & Distribution
OUR PROCESS
A Long-Term Focus
We help clients consider the long-term strategy of their development program, optimizing decision-making in early stages to achieve optimal efficiency and costs in later phases.
01
Early Stage
We can develop or optimize your formulation and process to help you achieve success in the clinic and make your clinical program commercially ready.
02
Late Stage
Whether you need Ph III material or beyond, we have more than three decades of experience helping our clients make it through the last critical clinical stages and bring their GMP drug product onward through FDA approval.
03
Storage and Distribution
Our controlled-access and video-monitored labeling and packaging suites are adjacent to controlled-temperature storage for seamless transfer between areas before shipment to your clinical sites.
OUR FACILITIES
Liquid or Lyo, Vial or Syringe
For over 24 years, Pyramid Labs has been a cornerstone in clinical manufacturing and sterile fill and finish. Whether it’s liquid or lyophilized, vial or syringe, we can scale our capabilities to align with the needs of your clinical program. Our GMP-compliant facilities boast advanced equipment, including a 100% weight-check IMA vial filler, Cozzoli syringe filler and a state-of-the-art Telstar lyophilizer.
Ready to take the next step?
Reach out to us today to discuss your project needs. We're here to help!