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.
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 37+ years of experience to help you solve your development and supply challenges. Learn more about what it means to differentiate your development process with Pyramid Pharma Services.