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What You Can Expect from Us

FDA Application

Is yours a research-level study or is the goal to be included in an FDA submission?

Typically these projects require the development of an assay to show potency (e.g. drug release assay) or to demonstrate efficacy in an IND submission. Often a client company will need or want to demonstrate the “lack of” immunogenicity of their drug.

Our team of scientists will lead you through the type of assay you might need. During these communications our scientists will discuss the pros and cons of the various approaches so that you will be able to make an informed decision.

PROTEIN PRODUCTION, PURIFICATION, ANALYSIS

Our scientists will consult with you on optimizing protein production, protein purification and analytical analysis. If your protein is generated via recombinant methods, we will employ the appropriate affinity methods of purification. Should you wish a homogeneously purified protein, we will discuss the strategies with you prior to final purification.

Of course, if you have a protein purification strategy, we will gladly employ your purification scheme. With many of the protein purification protocols, we will develop a purification scheme to monitor increase in yields and specific activity. Should you not have a method to quantitate protein activity; our scientists will consult with you about assay development.

Need extra help in completing research in order to progress to development? We can help.

EFFICIENT: Often this research service is conducted as a “research” project with the understanding that it may lead into a GLP or GMP project. Thus, vendors and suppliers are always selected with the quality and sustainability required for the more rigorous laboratory or manufacturing practice.

CONSISTENT: Reagent lots are selected so that critical reagents are in sufficient supply so that there will be no change in the lot when the project progresses to development.

KNOWLEDGEABLE: If a client needs to study pharmacodynamics, such as receptor binding, intracellular metabolism, activation of secondary signals, our scientists will be able to aid in these in vitro studies.

CAPABLE: With a full cell culture facility and years of cell biology experience, mechanistic studies can be fully integrated into your program. We employ scientists who bridge the various fields of classical biochemistry, cell biology, immunology and molecular biology.

COLLABORATION: Our scientists can consult with you to further your research project whether it is a small segment of your program or a full-blown project.

Pre-Clinical and Clinical Services