The market for biologics, or biopharmaceuticals, is newer than you might think, but its impacts are wide-reaching and revolutionary. Biologics were introduced in 1982 and have become commonly used for a variety of well-known treatments and medications.
From hormones such as insulin to gene therapies and vaccines, the biopharmaceuticals field is a staple in maintaining the health of our populations in many relevant ways.
COVID-19 placed biopharmaceutical manufacturing companies in the spotlight as the world watched funding, research hours, and other resources being poured into developing a life-saving vaccine.
So, what does the development of biologics entail? And how does the biopharmaceutical manufacturing process differ from pharmaceutical manufacturing?
What is biopharmaceutical manufacturing?
Biopharmaceutical manufacturing is the process of developing biologics that are “synthesized…in bioreactors by living organisms such as yeast, microbes or mammalian cells.”
The biopharmaceutical manufacturing process will differ based on the organization and the substances they are working with, but the goal is to implement large-scale operations that produce consistent, quality batches of product for global populations.
The field of biologics is projected to see rapid growth over the next five years, fueled by a focus on biomedical engineering and a demand for more robust treatments for chronic illness.
Is biopharmaceutical manufacturing different than pharmaceutical manufacturing?
While biopharmaceutical manufacturing deals with products from natural sources, such as humans, animals, and other microorganisms, traditional pharmaceutical manufacturing often refers to the process of creating chemically synthesized drugs.
This is a critical difference.
Biologics require expert handling, as they are more prone to contamination and other environmental factors that can negatively affect the quality of the final product – which can result in harm to any user of the biopharmaceutical substance.
Biologics and Biopharmaceutical Cleanroom Environments
Due to the sensitive nature of biologics, biopharmaceutical manufacturing environments will often require cleanrooms to be used at different stages of filling, packaging, and processing to ensure the integrity of the final product.
These cleanrooms would typically be categorized between ISO Class 5-9, often requiring an aseptic environment and stringent cleanroom gowning procedures. Should any factors contribute to increasing particle count, and therefore the risk of contamination, in these biopharmaceutical cleanrooms, the purity of the biologics can be called into question.
Clean-Manufactured Cleanroom Apparel for Biologics
Clean manufacturing in accordance with current Good Manufacturing Practices (cGMPs) can help reduce particulate count on cleanroom apparel to help maintain your biopharmaceutical manufacturing environment.
With 99.999% bacterial and particle filtration efficiencies, Lakeland CleanMax offers both sterile and non-sterile configurations of our clean-manufactured cleanroom apparel line. Constructed with bound seams for additional reinforcement and low-linting microporous laminate film, our coverall, frock, and other configurations provide quality protection for your people, product, and process.
CleanMax is designed with your team in mind. Specially folded and packaged to reduce handling during donning, you optimize your cleanroom gowning process for greater confidence in your environment.