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Pre-formulation Research

Creative Biolabs can provide pre-formulation research through our CreDA™ developability assessment platform to address several important aspects of the formulation, including concentration, solubility, viscosity, and accelerated stability, for the drug candidate selection.

Therapy biologics, especially monoclonal antibodies, often require single doses of several mg/kg, with intravenous injection or infusion being the preferred administration routes. Most diseases, which are treated with antibody-based pharmaceuticals, are chronic and require continuous therapy. With regard to patient convenience and healthcare costs, it would be of great benefit if these drugs could be self-administered through subcutaneous/intramuscular injection by the patient, which would reduce the frequency of medical interventions by a physician or at a hospital. Thus, the availability of highly concentrated antibody solutions (above 100 mg/mL) that can be administered by the intramuscular/subcutaneous injection routes is essential. And the development of corresponding formulations is becoming a major focus during the developability assessment campaign.

Pre-formulation research of the drug candidates. Fig.1 Pre-formulation research of the drug candidates.

The Pyroglutamate Formation Assay

Therapeutic molecules, especially for antibodies, have aroused much attention due to their efficacy in treating a number of human diseases. Recent studies have suggested that these antibodies can trigger many side effects and toxicity in clinical trials, contributing to a high cost and high development fail rate. As a consequence, pyroglutamate formation assays have been generated by Creative Biolabs to evaluate manufacturability and safety profiling. In general, a sequence-structure analysis of specific antibodies will be conducted to reveal the function of pyroglutamate (pE) in antibody construction. Our assay has been widely used for testing pE content and further assess the stabilization of antibodies in vivo.

The Subvisible Particle Analysis

The manufacturability process requires small sample sizes, ranging from 0.1 μm to 100 μm. Meanwhile, the state-of-the-art in vitro and in vivo techniques have been developed to select the lead candidates. Currently, Creative Biolabs offers a wide variety of customized services to quantify the subvisible particle in biotherapeutic drug products. Pilot studies conducted by our labs have indicated that our assay is suitable for measuring the subvisible particulates in the < 10-micron size range. For instance, we have successfully accomplished many subvisible particle analysis projects by using light obscuration (LO). The LO instrument measures the size and number of particles by blocking light through a photosensitive region. The data have demonstrated that LO is a high-throughput technology that can provide a fast, accurate screening process.

Creative Biolabs is recognized as the world leader for providing the most diverse portfolio of the manufacturability assessment solutions for worldwide customers. We have accumulated extensive experience from the accomplishment projects and are very proud of our high-quality, omnidirectional services to meet any special needs of your research. For more detailed information, please feel free to contact us for more detailed communications and information.

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