Dear Readers of the Journal of Pharmaceutical Innovation:

It seems that when one opens a pharmaceutical magazine or refereed pharmaceutical journal these days, the bulk of the articles or manuscripts involve biologic agents in one way or another. Indeed, the explosion in the world of immuno-oncology and the abundance of available infused or injected medicines for such afflictions as rheumatoid arthritis and Crohn’s disease have driven biologics to the forefront of pharmaceutical development and commercialization. In addition, the growth in the number of antibody drug conjugates (ADCs) hitting the market is also fueling the publicity machine for biologics.

Despite this growth, the methods of manufacture have not changed in decades. At last summer’s Bioprocessing Summit in Boston, a plenary lecture by a high-ranking R&D head stated this fact. But things are changing. I just read an interesting article entitled “Introducing PAT/QbD to Biotech Production.” The author makes some excellent points about the slowness of bioprocessing personnel to adopt these technologies, which are a mainstay in small molecule production. Now both are being adopted at an ever-increasing rate. During my tenure at Bristol-Myers Squibb, staff in my Process analytical technology (PAT) development group showed that near-infrared (NIR) spectroscopy could be successfully utilized in a bioreactor to monitor both disappearance of reactants and formation of product. Such a technique can help maximize yield in the reactor and thereby lower the cost of goods.

So much for drug substance. The increase in biologic drug substance (BDS) production has led to a parallel growth in parenteral drug product manufacturing, most notably in aseptic processing. The need for additional parenteral production capacity was also driven by the COVID pandemic as an unprecedented demand for sterile fill/finish appeared almost overnight. Contract manufacturing organizations (CMOs) have been scrambling to expand their sterile manufacturing facilities. Consider this quote from an article entitled “Parenteral Drugs: A Growth Industry” “Given the infrastructure and expertise (talent, experience, etc.) required for pharmaceutical fill/finish, a great deal of partnerships have been, and continue to be, struck between Sponsors and CMOs.”

The Journal of Pharmaceutical Innovation regularly features articles on PAT and QbD, and this issue is no exception. You will find manuscripts that discuss many new pharmaceutical developments from both industry and academia. I continue to look for new ways to improve this journal and hope that this editorial stimulates our readers working in the biologics area to consider this journal as an avenue for presenting their work. I am gratified by the number of messages I have received from readers. Please keep them coming! Feel free to write me at sscypinski@comcast.net with any matters on your mind.