Issue link: https://www.e-digitaleditions.com/i/1499609
8 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2023 PharmTech.com WACOMK A - STOCK.ADOBE.COM T o protect patient safety, drug developers and manufacturers must consider every possible route of contamination of the drug substance (DS) or drug product (DP) through all stages of production. Even with a terminal filtration step, the risk of introducing contaminants downstream remains. Therefore, aseptic processes must be employed from the filling lines, containers, and stoppers to the air in the surrounding manu- facturing space to maintain a sterile environment throughout fill/finish. The growth in the aseptic processes equipment mar- ket reflects the importance of aseptic processing in the biopharma industry, with a compound annual growth rate (CAGR) of 7.2% and a projected market worth of $12.9 billion by the end of 2027 (1). This article explores the aseptic processing strategies biologics developers can integrate to safeguard DS and DP from contami- nation and examines the monitoring tactics helpful in maintaining a sterile environment. The importance of sterility Biologics are t y pically administered through par- entera l means and are direct ly injected into t he bloodstream. Administration via injection circum- vents many of the body's natural defenses and is a major reason the sterility of the final product is v ita l to sa fet y. Avoid i ng st r i ngent ster i l it y mea- sures by using oral dosage formats is not a suitable option for delivering biologics as the gastrointes- tinal system rapidly degrades them, making them ineffective in treating patients. Therefore, to pro- tect patients from serious infectious diseases such as meningitis and sepsis, sanitary manufacturing processes are critical in biologics production (2). Another fundamental step in assuring patient safety is to comply with regulatory requirements. Regulatory bodies, including FDA and the European Medicines Agency, have published stringent guidance and rec- ommendations for sterile DPs produced by aseptic pro- cessing (3,4). As well as providing guidance on steril- Aseptic Processes Safeguard Biologics Jeong Jin-hyeok is principal scientist in drug product at Samsung Biologics. Aseptic techniques must be practiced throughout all stages of biologics production.