A1M Pharma is developing a recombinant A1M molecule (rA1M) that can be used as a drug. Recombinant means that the drug is produced by modifying DNA in an organism to enable it to start producing a certain substance, for example a drug. One example of this is the successful production of insulin for diabetes sufferers by using E.coli bacteria. A number of drugs have been developed in recent decades using recombinant DNA technology. This discovery has been recognised with a Nobel Prize in Chemistry.
Lena Rosenlöf
Lena Rosenlöf, a senior researcher at A1M Pharma AB, is responsible for the manufacture of ROSgard using recombinant DNA technology.

Can you tell us a little about your current R&D work?
“We developed a process for producing rA1M in our own lab, where we identified the critical parameters for successful production. Using this process on a small scale, we have been able to produce a few grams at a time. Among other things, we have used this material to verify that the rA1M protein we produced has the same properties as the endogenous protein. We have also studied rA1M’s stability in a variety of preparations. To aid us in this work, we have developed sensitive analysis methods used to determine the function and other properties of rA1M, as well as the endogenous protein A1M.”

How have the process and these methods moved on?
“Everything we have developed in the lab has been transferred to a contract manufacturing organisation, which has scaled up the production process and adapted it to meet the specific requirements for industrial, quality-assured production. They have similarly adapted and quality-assured our analysis methods. Consequently, we are ready to produce rA1M material that can be used for toxicity studies and then in clinical trials.”

What do you appreciate most about being a member of the research network of Professor Åkerström and Professor Hansson?
“The team comprises members with wide-ranging expertise – from a deep understanding of the biochemistry of the A1M molecule to extensive clinical knowledge and experience of how pre-eclampsia is diagnosed and treated.”
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