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Particles in an injectable drug product represent a huge risk not only to patient safety – but also to a drug company’s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the FDA Recalls, Market Withdrawals, & Safety Alerts database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination¹.

An enormous growth trend is being observed in the market for biologic drugs; they are being employed ever more frequently as treatments for chronic issues such as cancer and autoimmune diseases. This growth is reflected by the number of companies involved (established and emerging), and in the capital investment for manufacturing facilities for both biologics and biosimilars. Companies must apply a holistic approach to bringing a biologic drug to market. 

There is no doubt biologics and biosimilars will remain one of the hot topics in 2021. This is due to the pandemic period of SARS-CoV-2 and the innovative treatments and vaccines that are under development at accelerated speed. Several questions can arise regarding selection of the proper primary package system for a biologic/biosimilar.

In recent years, an increasing variety of biologic drugs have been developed including vaccines, recombinant proteins, gene and cell therapies. In China, this increased demand will be reflected in a significant growth in the size of the bio-pharmaceutical industry. As a result, the Chinese government is increasing its investment.

Biologics is a rapidly growing market, with a robust R&D pipeline bringing innovative therapies to treat patients. Today, there are 4,000 more active biologic programs in the pipeline compared to 2015, with biologics development programs growing 2.5 times faster than small molecules. New entrants into the biologics market are driving this rapid growth. As of 2018, emerging companies represented 84% of all early phase research.¹ Not only is this segment driving R&D growth, but they are having commercial success in bringing their drugs to market. In 2018, 65% of new drugs launched were patented by emerging companies.¹

Biologic drug products are not new – their development began decades ago; the first monoclonal antibody was commercialized in 1986. ^[1] With the increasing availability of genetic information, and better understanding of subcellular cascades and disease processes, the number of biologic drug products available has increased substantially in response to an exponential growth in targets. ^[2]