Adoption of continuous manufacturing brings tangible benefits to pharma companies

Abstract

The development of agile, continuous manufacturing (CM) systems will be one of the most significant changes in the pharmaceutical industry in the next fewyears. Continuous manufacturing has more advantages compared to batch manufacturing. Many big pharma companiessuch asPfizer, Eli Lilly,andJohnson and Johnson have established new facilitiesforcontinuous manufacturingof APIand formulation. Omnichemand Lonza(Contract Manufacturing Organization) arealso expanding their manufacturing facilitiesto accommodate continuous reactors for production of APIs.

Introduction to continuous manufacturing

Most of the pharma companies use batch manufacturing for the production of active pharmaceutical ingredients. Batch manufacturing is a discrete process in which the feed or raw material is initially loaded or introduced into the fermenter at the beginning of the process and the final product is unloaded or removed after the reaction time.

Continuous manufacturing is a continuous process where the APIs are produced in highly-automated closed units under optimized conditions. Currently, biosimilar manufacturing is carried out in Perfusion Bioreactors, which is a continuous manufacturing process. It helps to save time and costs, is flexible, and increases productivity.

Big pharma companies such asJohnson and Johnson, Eli Lilly, Glaxo Smith Kline, and Pfizer have understood the advantage of installing continuous manufacturing systems in their facilities. Lonza had already installed continuous manufacturing system at its facility in Visp, Switzerland for the production of vitamin B3 nutrient,Niacin. Nearly 40 tons of the drug is produced per day meeting half of the world demand for Niacin. Also Janssen Pharmaceuticals produces Prezista (HIV Drug) through continuous manufacturing process. Janssen claims the continuous manufacturing methodology can reduce operating costs by as much as 50percentand provide increased production volume while requiring less API and reducing waste.Janssen can now produce 600 mg tablets, which integrates weighing, milling, blending and compression. Janssen and Johnson and Johnson manufacture about 70percentof their highest volume products by using continuous manufacturing technology.