Injectables and Parenterals CDMO
Particle Sciences has developed formulations for all routes of parenteral administration, including intravenous, subcutaneous, intramuscular, and implantable dosage forms. Most of our development programs involve injectable formulations, so we have considerable experience developing solutions, suspensions, nanosuspensions, emulsions, semi-solids, and lyophilized powders for parenteral administration.
Ready for your API
We’ve worked with a wide range of APIs, especially those with poor water solubility (BCS Class II/IV) and stability. Our team has experience with highly potent compounds, DEA controlled substances (Schedule I-V), and large molecules, such as proteins, peptides, and nucleotides. We have Grade A aseptic filling suites that allow us to fill vials, syringes, cartridges, and injector devices. In addition, we also utilize Grade A isolator technology that enables processing flexibility. Our ability to handle a range of APIs combined with aseptic processing capabilities help ensure the success of your parenteral product.
A portfolio of drug delivery technologies
Particle Sciences has a number of drug development technologies that allow us to explore different approaches for your drug product. With a portfolio of options to choose from, we partner with customers to find the approach that best achieves their technical and commercial goals. We are also uniquely positioned to transfer in proprietary or academic technologies/processes and bring them into GMP production.
Our technologies include:
- Aseptic Fill-Finish
- Spray Drying
- Hot Melt Extrusion
- Injection Molding
- Tangential Flow Filtration (TFF)
- Powder Filling
Broad expertise: from simple solutions to long-acting drug delivery
Long-acting injectables and other sustained-release products are an area of growing interest that adds complexity to the development process. At Particle Sciences, we are strong in the basics and experts in the complex. While much of our work involves simple solutions and powders, we are best known for more challenging formulations. Whether you are developing a generic or formulating a new chemical entity, we have experience developing and manufacturing long-acting products such as polymeric implants. Our formulation team is complemented by a seasoned quality department and a best-in-class analytical team who develop and validate methods to reliably measure critical quality attributes, such as drug degradation and release rate.
A Purpose-Built Commercial Manufacturing Facility for Complex Drug Products
While CMO market capacity is adequate for mainstream products, there is a lack of manufacturing capacity for the rapidly growing sub-segment of complex drug products. Such a facility requires not only purpose-built infrastructure but also a highly specialized staff. To fill this gap, we have established commercial production for complex drug products, leveraging our decades of know-how as a leading product developer and clinical stage manufacturer. The facility is separate but adjacent to the existing development and clinical trial manufacturing site, offering customers a seamless flow from development through manufacturing – a one-stop shop.
We understand the physical and chemical properties that make biopharmaceuticals and biosimilars different from small molecules. Our team is adept at formulating large molecule therapeutics such as proteins, peptides, and oligonucleotides while maintaining biological activity. We also offer characterization, formulation, and aseptic manufacturing services.
Our formulation team employs a data-driven approach to find solutions for even the most challenging APIs employing a range of technologies to maximize bioavailability, control release rate, and enhance stability. Our scientists work on projects from early-stage development through scale-up and transition to our clinical and commercial manufacturing teams.
Our purpose-built commercial manufacturing facility is ideally suited to sterile and complex drug products, including those with small batch sizes and sterility requirements. We have GMP manufacturing space that features a well-equipped processing room as well as Grade A filling and lyophilization suites.
Our analytical services range from early stage method development through commercial validation. We are expert in complex sample preparation, and our experienced staff will help you design and execute a phase-appropriate analytical strategy.