Nucleic Acid Drug Evaluation and Bioanalytical Services

CD Formulation offers specialized nucleic acid drugs evaluation and bioanalytical services. Our experienced team uses state-of-the-art instrumentation to deliver high-quality bioanalysis and evaluation to support drug pharmacokinetics, pharmacodynamics, immunogenicity, and biomarkers from drug development to scale-up.

Why Nucleic Acid Drug Evaluation and Bioanalysis?

From the perspective of industry regulations, conducting bioanalytical, pharmacokinetic (DMPK), and pharmacodynamic evaluation studies as early as possible in the initial stages of new drug development will play a crucial role in enhancing the efficiency of drug research and development and reducing the risk of failure in later stages. Currently, bioanalysis plays an essential role in providing data support throughout all phases of new drug development. During the drug evaluation and bioanalysis process, it is essential to have access to large-scale and highly advanced instruments, and an internationally recognized laboratory information management system. Additionally, in accordance with regulations, these instruments must adhere to the bioanalytical guidelines and regulatory requirements, and comply with the professional standards of bioanalytical services.

Fig.1 Digital PCR for nucleic acid. (Wang L, et al., 2016)

Explore Our Nucleic Acid Drug Evaluation and Bioanalytical Services

At CD Formulation, we specialize in nucleic acid drug evaluation and bioanalytical services, focusing on three key areas: safety, exposure, and efficacy. Our team is dedicated to helping our clients evaluate the safety of their drugs, measure exposure levels in a variety of biological matrices, and assess efficacy. Whether it's a small nucleic acid analysis or an mRNA vaccine bioassay, our expertise and cutting-edge technology ensure that we deliver the most accurate and reliable results.

Our services encompass method development, transfer, validation, and sample analysis. Additionally, we offer methodology validation programs, bioanalytical solutions, and review all aspects of GLP/GCP project protocols, progress, and reports to guarantee accurate, reliable data that complies with filing requirements. Presently, we specialize in nucleic acid drug evaluation and bioanalytical services, which include:

Customized Analytical Method Development

Our bioanalytical laboratories support method development and validation strategies with a wide range of cutting-edge technologies, state-of-the-art equipment, and solutions. Unlike other analytical services, our team of experts customizes the optimal solution for your drug development to help you achieve your goals. We evaluate key reagent needs and recommend the best reagent options.

Our Technology Platforms for Nucleic Acid Drug Evaluation and Bioanalytical Services

Immunoassay Platforms

• ELISA
• MSD (Meso Scale Discovery)
• ELISPOT
• Flow Cytometry

Mass Spectrometry Platforms

• LC-MS/MS
• MALDI-TOF MS

Molecular Biology Platforms

• RT-qPCR (real-time quantitative PCR)
• Digital PCR
• Northern Blot
• WB-seq (Western Blot Sequencing)
• Single Cell Sequencing

Imaging Technology Platforms

• PET (Positron Emission Tomography)
• Fluorescence Imaging

Bioinformatics platforms

• PK/PD Modeling and Analysis Software
• Biomarker Analysis Software

Why Choose Us for Nucleic Acid Drug Evaluation and Bioanalytical Services?

• With experienced scientists in the field of pharmaceutical bioanalysis, advanced instrumentation (LC-MS/MS, ELISA, MSD), we are able to provide sponsors with a full range of pharmacokinetic research services.
• Our Bioanalytical Center operates according to the highest quality standards and provides professional research services to our clients. We assist them in shortening their drug submission and marketing authorization cycles, ensuring high-quality compliance.
• We have established a quality management system to capture any non-compliance or deviation identified during a study and implement effective corrective and preventive action mechanisms.
• We are recognized as a preferred partner for many biopharmaceutical companies because of our strict quality standards and transparency at all stages.

CD Formulation's bioanalytical and drug evaluation services can assist you in optimizing your drug development program and ensuring that you have the technical insight required to successfully complete your bioanalytical studies. Contact us, our pharmacologists have the expertise and flexibility to help you with complex assay development and validation for the quantitative analysis of drugs, metabolites, and biomarkers in biological samples.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.