“Biopharmaceuticals now represent the major pipeline of blockbuster drugs for the coming years,” said Mike Brailsford, general manager at Parker Bioscience. “The move from traditional chemical-based processes for pharmaceutical manufacture to biological processes has been growing for the past 15 years.”
Today, this trend is now “fully established,” said Brailsford – a shift which has led to global investment in new biopharmaceutical manufacturing facilities as well as the conversion of existing facilities to biologic facilities.
“This move is driving consistent double-digit growth in this market which is expected to continue for the foreseeable future,” Brailsford told us, noting that “single use products are critical to this market as without this cleaning of equipment between batches is very difficult to manage.”
Parker Bioscience today announced the launch of a new automated single-use system.
The SciLog SciPure FD System combines fully the automated bulk filtration and dispensing of biopharmaceutical products with a shipping solution to safeguard product integrity, according to the company.
The company created a patent-pending bottle design that has been validated down to -89˚C while undergoing a validated shipping study (ASTM D4169).
To meet increasing demand for biopharmaceutical services, Parker Biosciences late last month announced a multi-million dollar expansion at its UK-based site.
The phased investment program next month will see the addition of a new class 7 clean room facility for the manufacture of single-use assemblies used in biopharmaceutical manufacturing.
“These assemblies are supplied to biopharma customers fully assembled and sterilized ready for direct use in their sterile clean room facilities in the manufacture of drug products,” said Brailsford.
The expansion also will include a new manufacturing area for single use sensing technologies, which Brailsford explained allow users to monitor process parameters such as temperature, pressure, and conductance.
In November of this year, the company will complete office refurbishment for its expanding workforce, which includes “a significant intake of younger employees into new areas of the business and to support our business growth,” Brailsford said.
The quality control (QC), research and scientific support laboratories also will be expanded at this time. The facilities will provide capabilities including microbiology testing, scanning electron microscopy, through to pilot scale facilities. Additionally, a new facility for the development, manufacturing, and commissioning of automated manufacturing systems will be added.
To “meet the demands of the growing business,” Parker will complete construction of a new warehouse in early 2019, Brailsford explained.
By late 2019, the existing clean room manufacturing area will be redeveloped and upgraded to class 8. The floor area available for manufacturing filter products also will be expanded.