From the Laboratory to the Clinic

After a promising new drug has undergone initial evaluation, much must to be done before the compound can be tested in humans. Its developer must demonstrate to the relevant regulatory agency (e.g., the FDA in the US) that the compound can provide a potential therapeutic benefit with an acceptable level of risk. Its developer must provide extensive information related to how the compound will initially be studied in humans. And, its developer must prove that the drug can be reliably manufactured in compliance with the FDA's requirements for current Good Manufacturing Practices (cGMPs), which are significant.

We use our experience in all of these areas to develop our own compounds and assist our partners. Of particular interest to our partners is our ability to manufacture TAP compounds in compliance with cGMP. Our partners typically have extensive expertise in the development of novel anticancer drugs and many of them are highly experienced manufacturers of antibodies and/or small molecules under cGMP. The production of these agents, however, is very different from the production of a therapeutic that consists of a defined number of toxic small molecules attached to an antibody in a manner that retains the critical properties of the antibody.

ImmunoGen: Unique Development Expertise

Over the past few years, ImmunoGen has manufactured many different TAP compounds under cGMP. Our development capabilities include:

• Process development - To manufacture a TAP compound, one needs a process that reliably attaches a defined number of molecules of the cell-killing agent to the antibody without significantly altering the binding properties of the antibody and that consistently yields product of high purity and stability. ImmunoGen developed the production process for every TAP compound manufactured.



• Technology transfer - Every process developed has to be transferred from the scientists who create it to the production personnel who need to reliably implement it in a manufacturing setting. ImmunoGen transitions processes seamlessly: we have our own pilot manufacturing facility, staffed with ImmunoGen production and technology transfer personnel who interact regularly with our process development team.



• Process scale up - The amount of product that needs to be produced is fairly small when a TAP compound starts clinical evaluation, but becomes substantial as it advances. Modifications must be made to the manufacturing process so far greater quantities are produced, and these changes must be acceptable to regulatory authorities. ImmunoGen has successfully scaled up production processes for multiple TAP compounds.



• Assay development - Assays need to be developed that can reliably quantitate each TAP compound and assess its purity and other essential characteristics. Such assays are used in quality control release testing. Assays also are used to establish the pharmacokinetics of the compound in preclinical and clinical studies. ImmunoGen has successfully developed quality control, preclinical and clinical assays for many different TAP compounds. In addition, a number of sophisticated techniques, such as high resolution mass spectrometry, are used for detailed analysis of the compounds.



• Formulation development - With any new drug, a formulation must be developed that reliably maintains the critical properties of the product over its desired shelf-life. With a TAP compound, the formulation must prevent the changes that protein biologics can undergo (e.g., oxidation and aggregation) plus changes to the cell-killing agent. Our scientists have created effective formulations for a number of TAP compounds in development by us and our partners.

These capabilities help us attract high quality partners, negotiate excellent financial terms, and derive compensation for the development work we do on behalf of our partners. Very importantly, we use these capabilities to advance our own products.

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