Analytical Development

Pegasus Biotech is a contract research organization (CRO) that specializes in the development of customized assays for vaccines and biologics. Our analytical development team is comprised of experienced scientists with in-depth knowledge of all current analytical techniques and their applications. We work closely with our clients to design, develop, validate, and transfer analytical methods that meet regulatory requirements and support the development and characterization of drug candidates.

Cell-Based Assays:

At Pegasus Biotech, we understand that the development of customized bioassays can be a complex and challenging task. Our team maintains a large selection of cell lines in-house, enabling us to design and develop cell-based assays that are specific to the client's needs. Our experts work closely with our clients to understand their unique requirements and develop an assay that meets their specific needs.

Our custom bioassay development services include the establishment of optimized cell-based assays that evaluate the biological activity of your API. We have extensive experience in developing potency assays, neutralizing antibody assays, and cell-based assays that measure cell viability, proliferation, and apoptosis. We utilize various detection methods, including fluorescence, luminescence, and absorbance, to ensure accurate and reliable results.

ELISA:

Our enzyme-linked immunosorbent assay (ELISA) services include the development and validation of assays for the measurement of various biomolecules. We specialize in developing assays for various applications, including biomarker detection, vaccine development, and antibody quantification. Our team of experts uses the latest techniques and reagents to ensure accurate and reliable results.

Our ELISA development services also encompass reagent generation, antibody generation, and antibody labelling. We have experience in generating monoclonal and polyclonal antibodies against various targets, including small molecules, peptides, and proteins. Our antibody labelling services include the conjugation of antibodies with various detection systems, including fluorescent dyes, biotin, and enzymes, to enhance assay sensitivity and specificity.

qPCR:

Our quantitative polymerase chain reaction (qPCR) services include assay development and validation for the detection and quantification of specific DNA and RNA molecules.. Our experts use the latest instrumentation and reagents to ensure accurate and reliable results. We follow stringent quality control procedures to ensure the accuracy and reproducibility of our assays.

HPLC:

Our high-performance liquid chromatography (HPLC) services include the development and validation of assays for the separation and quantification of biomolecules. We have experience in developing assays for various applications, including purity analysis, impurity identification, and stability studies. Our team uses state-of-the-art equipment and techniques to ensure high-quality results. We have a proven track record of delivering reliable and reproducible results to our clients.

Particle Sizing:

Our particle sizing services include the development and validation of assays for the measurement of particle size and distribution. We have experience in developing assays for various applications, including vaccine development, drug delivery, and nanoparticle analysis. Our team uses the latest techniques and instrumentation, utilizing dynamic light scattering (DLS) to ensure accurate and reliable results. We work with our clients to design assays that meet their specific requirements, ensuring that the data generated is of the highest quality.

Viscosity Measurement:

At Pegasus Biotech, we provide viscosity measurement services that help our clients in the development and optimization of various biologic formulations. Viscosity measurement is an essential parameter for understanding the rheological behavior of protein formulations, which is crucial for predicting their stability, performance, and delivery. Our team of experts has extensive experience in designing and validating viscosity assays for different applications, including formulation development, and stability studies.

Pharmacopeia Compliant Methods:

We understand that developing biologics that meet regulatory requirements is critical for our clients' success. Hence, we offer pharmacopeia-related methods that adhere to the strict regulatory standards set by various pharmacopeias, such as USP, EP, and JP. Our team of experts has extensive experience in developing and validating assays for different pharmacopeial applications, including purity analysis, impurity identification, and stability studies. We use state-of-the-art instrumentation and techniques, such as HPLC, to ensure that our methods comply with regulatory requirements and generate high-quality results. We work closely with our clients to develop customized pharmacopeia-compliant assays that meet their specific requirements, ensuring that their projects are successful and meet regulatory standards.