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  • What We Do
    Our Services

    We offer the pharmaceutical and biotech industries a wide range of services for both Clinical and Commercial products.

    Drug Product Development

    Formulation and process development for liquid & lyophilized products

    Lyophilization

    Development and GMP manufacturing for lyophilized drug products

    Clinical Manufacturing

    GMP manufacturing and distribution for clinical trials

    Commercial Manufacturing

    FDA-registered facility currently making products for global distribution

    Biologics & Novel Modalities

    Drug product development and manufacturing for biologics and other novel modalities

    Analytical Services & QC Testing

    Method development, validation and testing

    Stability Studies

    Long-term, accelerated and in-use GMP stability studies

    Quality Assurance & Regulatory Support

    GMP manufacturing, testing and associated processes

    Labeling, Storage & Distribution

    ICH-compliant temperature controlled GMP storage and global distribution

  • How We Help
    Overview

    Pyramid Labs has helped many clients on their journey from early stage all the way to commercial approval.

    Formulation & Development
    Formulation & Development

    Pyramid Labs has a proven track record of helping clients successfully move from clinical stage to commercial approval.

    Clinical Supply
    Clinical Supply

    Pyramid Labs has a proven track record of helping clients successfully move from clinical stage to commercial approval.

    Commercial Production
    Commercial Production

    Pyramid Labs manufacture multiple commercial drug products for distribution to international markets.

  • About Us
    Who We Are

    We deliver the highest quality from early-stage development through commercial production.

    Our Expert Team

    Our accomplished team brings expertise in formulation, testing, and manufacturing — ensuring top-quality services.

    Work At Pyramid

    Join us in shaping the future of drug development and manufacturing, one breakthrough at a time.

  • News & Events
    News
    Upcoming Events
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Clinical Supply

Our aseptic, sterile clinical manufacturing services span formulation, processing and filling capabilities for both vial and syringe applications, serving biotech and pharmaceutical clients in all regulatory phases. Whether you need pre-clinical services, stability studies or clinical-grade formulation, you will have the combined expertise of our entire team supporting your project.

OUR PROCESS

Clinical Product Processes & Formulations: Any Molecule, Every Challenge.

Relying on our experience, track record and shared commitment, we specialize in processes and formulations for a wide range of clinical products, from simple solutions to even the most complicated delivery systems containing proteins, oligonucleotides, peptides and liposomes.

01

Development

Our capabilities include aseptic filling of various products with equipment designed for low-volume aseptic fills. We are highly specialized in developing and filling compounds with low solubility.

02

Vial & Syringe Filling

We fill a wide range of vials, from 2 mL to 20 mL, with an aseptic filling machine designed for up to 250 mL. Our syringe filling and stoppering system utilizes the Becton Dickinson Hypak™ system, and our liquid processing capabilities range from volumes less than one liter to over 100 liters—at a variety of fill volumes. We routinely fill syringes from 0.5 mL to 3 mL.

03

Lyophilization

Our clinical freeze dryer can lyophilize batches up to 7,000 vials, depending on the vial size. A 213 S.F. lyophilizer is also available for larger clinical batches.

OUR SERVICES

Critical Expertise & Support from Clinical to Commercial

Your late-stage program needs a CDMO with the technical expertise and track record of regulatory success to support the various challenges standing between you and commercial approval. Late-stage clinical supply, process validation and providing guidance during regulatory inspections and approvals are our specialty.

Drug Product Development

Formulation & process development for liquid & lyophilized products

Lyophilization

Development and GMP manufacturing for lyophilized drug products

Stability Studies

Short-term & long-term stability studies at all ICH conditions

Quality Assurance & Regulatory Support

Our dedicated Quality Assurance team ensures that all work is conducted in strict compliance

Labeling, Storage 
& Distribution

ICH-compliant GMP storage. Global distribution

Analytical Services & QC Testing

Method development, validation and testing

Our Capabilities

Our Clinical Know–How. Your Peace of Mind.

We pair the clinical supply services you need with a collaborative culture involving all subject-matter experts and company leaders, up to the top. Uniquely, we’re able to work across development and clinical & commercial manufacturing, so you will have one team dedicated to optimizing your product at every stage.

Contact Our Experts

OUR FACILITIES

Minimal Losses, Maximum Yield

The development of clinical drugs can be expensive. Our systems and practices are designed to minimize losses, ensuring clients have the highest maximum yield of finished product possible. Our state-of-the-art, commercial-scale manufacturing facility can accommodate the transfer and scale-up from Phase 3 clinical to commercial manufacturing.

How Can We Help?

Let us apply our 36+ years of experience to help you solve your drug development and supply challenges. Learn more about what it means to differentiate your development process with Pyramid Labs.

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A trusted drug development and manufacturing partner, 37 years and counting.
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