Specialists in Injectable Products and Processes
Pharmaceutical Development Services
Kamat Pharmatech provides contract development services to pharmaceutical and biotechnology companies. It has helped clients achieve the FDA Approvals and FDA Filings of more than twenty injectable products, including biological, oncology, and potent drugs. The phamaceutical development services we offer are organized in the following activities:
Lyophilization OverviewKamat Pharmatech offers comprehensive lyophilization development services.
Lyophilization is a manufacturing process which removes water from unstable liquid formulations to yield stable dry solids with long shelf-lives. The technique uses near-vacuum pressures and sub-zero temperatures to sublimate the solvent, which is typically water. This is especially useful for biological formulations which are unstable during the atmospheric drying process.
We understand lyophilization of small molecules and biologicals and have helped clients bring their products to the commercial scale.
Our lyophilization services are conducted under the supervision of Dr. Madhav Kamat, an industry-recognized expert in the field of lyophilization. Kamat Pharmatech delivers its lyophilization services with a robust understanding of scientific principles and practical implications.
The following figure is a schematic representation of a typical freeze-drying process:
We are involved with preformulation studies, thermal characterization, cycle design and optimization, quality by design, and scale-up to manufacturing.