HPAPIs And Bioconjugates

Tom Gelineau, Director, Business Development, at SAFC, speaks to Pharmaceutical Technology Europe about the market for HPAPIs and the key trends influencing HPAPI bioconjugates.
Aug 31, 2011

On an industry level, how would you characterise the overall market for HPAPIs?

The market is growing rapidly—probably the most aggressive growth rate that we see in the pharmaceutical market today. There is real emphasis on oncology; it is becoming increasingly clear that many potent compounds are more highly effective in this area and an increasing number of our clients are consequently developing such compounds. Success with being able to better target HPAPIs and increase their effectiveness has also increased demand and helped grow the market. I expect this trend will continue.

What would you identify as the key trends influencing the market for HPAPI bioconjugates?

Several different delivery mechanisms are currently being developed, including antibody–drug conjugates and liposomal formulations. They are beneficial because they help the potent drug to target a particular site, which typically results in being able to dose the patient with smaller quantities of highly cytotoxic drugs. Smaller quantities of drugs mean fewer side effects, so patients usually have a better quality of life; for example, hair loss and nausea can be reduced. The targeted delivery approach also allows more of the drug to get to the target area more quickly, so treatment can be shortened.

A key trend here is antibody–drug conjugates (ADCs); we see more highly potent compounds being conjugated to antibodies than probably any other targeted delivery platform.

Have there been any recent developments at SAFC with HPAPIs or bioconjugates that you think have been significant?

Recently, we have been expanding our capacity for HPAPIs. We brought a facility online in January 2011 to produce highly potent compounds by bacterial and fungal fermentation in Jerusalem (Israel). Demand is definitely increasing. Within the past year, we also built a large-scale manufacturing facility in Verona, Wisconsin (US) which enables us to manufacture HPAPIs at a 200kg scale, which is at the higher end of production scale currently available.

We also have plans to build commercial antibody-drug conjugate capability in addition to our conjugation facility in St Louis (US). That capacity is filling up very well, hence our plans to create a further facility to carry out conjugation at commercial scale.