The RiteDose Corp. is implementing engineering innovations to its Columbia production lines that the company says will increase production capacity by as much as 25% above industry standards.
RiteDose, born from the inventors of Blow-Fill-Seal technology, is a leading BFS Contract Development and Manufacturing Organization. The innovations will allow the company to meet increasing demand for its products, which include sterile drugs for inhalation and ophthalmology, and to bring new product lines for pharmaceutical companies to market faster, according to a news release.
“Our engineers have made significant changes in our production methodology and processes that will allow us to increase production capacity by up to 200 million units per year — substantially beyond standard industry outputs,” RiteDose CEO Jody Chastain said in the release. “This latest innovation pushes our BFS capacity to more than 2 billion units annually.”
The innovations are part of a $20 million capital avoidance strategy that RiteDose said will create more flexibility in its production capacity and capability.
RiteDose has been a leading CDMO in the BFS arena since the late 1990s when the company, then known as Holopack International, received FDA approval to manufacture and distribute drug products. During the COVID-19 pandemic, the company expanded to include a new 503B Outsourcing Facility to supply sterile injectable products to health care facilities nationwide.
“RiteDose has been an invaluable partner in developing robust manufacturing processes and successfully scaling up manufacturing to support our pipeline of innovative drugs,” Vijay Sabesan of pharmaceutical developer Theravance Biopharma said. “In addition to the extensive expertise in BFS manufacturing, we greatly value their flexibility and collaborative approach.”
BFS is an aseptic fill-finish technology that uses a low-density polyethene processed in a five-step operation. Medical-grade, molten plastic resin is extruded through a nozzle and blown with sterile air to form a tube called a parison, which is then blow-molded into a container shape. The containers are filled with a formulation and sealed, then processed for leak detection, packaging and distribution.