Biopharmaceuticals products are molecules that are components of biological systems (or analogs of or antagonists of comparable biological molecules) that are used in the treatment of human and animal health and disease. The applications of biopharmaceuticals include: agonist and antagonist of important receptors and enzymes, replacement products to treat genetic defects, the induction of protective immune responses (vaccines), and the inhibition of inappropriate immune responses (treatment of allergy and autoimmunity). They can also be combinations of biological molecules like antibodies with cytoxic compounds and agents, such as antibody-drug conjugates that are being used today in cancer therapies.
Particle Sciences brings decades of experience to the formulation and delivery of Biopharmaceuticals. While we use traditional methods, our patent pending, non-covalent approaches are truly differentiated. Through the use of electrostatic and hydrophobic interactions we create formulations that meet your performance needs while minimizing the regulatory, product characterization and product release burden. We can:
Particle Sciences facility includes cGMP analytic and bioanalytic labs and our physical characterization capabilities are second to none. In our clean rooms, including ISO 5 suites, we can handle highly potent compounds and DEA controlled substances. In addition to a host of formulation techniques, we have lyophilization and spray drying capabilities.
Particle Sciences has assembled a set of technologies aimed specifically at improving the performance of Biopharmaceuticals. Below is a sampling of our approaches. Please contact us with your specific needs to see how we can be of assistance.
Antibody-Drug Complexes: Using our proprietary approach, your targeting ligand or therapeutic large molecule is attached to a nanoparticle that is loaded with the API(s). For example, a nanoparticle loaded with an oncology agent used as a core that is decorated with your targeting moiety, a monoclonal antibody for instance. This provides a greater drug-to-ab ratio and, because the actives are not covalently modified, a smoother regulatory path.
Encapsulation: Using solid lipid nanoparticles or oil core nanoparticles provides extended delivery and, for oncology agents, tumor targeting
LyoCell®: Combines a lipid based approach with nanoparticles. Leveraging the power of reverse cubic phase geometry, the hydrophobic and hydrophilic domains in these nanoparticles are never more than a few nanometers apart giving the particles unique solubilization properties. The technology uses GRAS ingredients and is useful in virtually every dosage form.
PegPlus®: Particle Sciences proprietary PEGylation technology
Virus-Like Particles: Particle Sciences uses custom fabricated nanoparticles as the core to which we bind your antigen and, if used, adjuvant. Through this patent pending technology, we can rapidly produce variations with different antigen and adjuvant densities and ratios. This formulation technology can be optimize for both immune potency and safety profile.