Large Molecule PK/BA Services
Creative Animodel has a brilliant history of providing the large molecule Pharmacokinetics (PK) and bioanalysis (BA) service with adherence to GLP regulations to advance the pharmaceutical industries. Equipped with the state-of-the-art technical platforms, our studies are performed by an innovative expert team that ensures consistent, high-quality, and on-budget data, with a fast turnaround time.
Large molecule drugs, referred to as biologics, are protein-based drugs, which are manufactured in living cells or contain components of living organisms by biotechnology, while the traditional small-molecule drugs are often manufactured via chemical synthesis. As the most advanced therapies available, biologics have been widely applied to treatment of numerous diseases and conditions, especially those hard-to-treat ones, like cancer.
Why Do We Highlight Large Molecule PK/BA Services?
Large molecules are different from small molecules in many aspects, such as size, behavior, mode of action, suitability for certain drug forms and manufacturing process, etc. Compared to small molecule drugs, large molecule drugs require approximately five times of quality assurance tests to ensure purity, potency, and quality. Because with a more complex structure, large molecules are often hundreds of times the size of small molecules, which are highly sensitive to temperature and pH, and susceptible to minor changes of conditions, likely leading to an increased risk of unexpected immune responses. All these factors drive the special concerns for large molecule PK/BA services.
Apart from this, the distinctive ADME characteristics of large molecules also highlight the need for ADME characterization and safety-related studies in drug development of biologics.
Figure 1. The size comparison of atorvastatin, a small molecule, and the other two large molecules.
Large Molecule PK/BA Services at Creative Animodel
The large molecule PK/BA services at Creative Animodel aim at studying the in vivo pharmacokinetics (PK), toxicokinetics (TK), immunogenicity (ADA), and immunoassays of large molecule drugs like monoclonal antibodies, antibody drug conjugates (ADCs), bispecific antibodies.
Figure 2. The comprehensive portfolio of large molecule PK/BA services from Creative Animodel.
Our Capabilities include:
• Expertise in PK/PD, toxicity studies, ADA, and immunoassays, including experimental operations and statistical analysis.
• Advanced technical platforms, such as the LC-MS/MS and ELISA platforms.
• A variety of animal models available to best suit for your research.
• Comprehensive data reports, and more parameters on your request.
• Adherence to GLP regulations.
• Decades of pharmaceutical experience.
Creative Animodel provides a wide range of outsourcing services to support all the stages of drug research and development. With a brilliant pharmaceutical history, we pride ourselves in delivering reliable data both on time and budget. If you have any additional requirements or questions, please do not hesitate to contact us.
Vugmeyster, Y.; et al. Pharmacokinetics and toxicology of therapeutic proteins: advances and challenges. World journal of biological chemistry. 2012, 3(4): 73.