A Delaware-based public-private biopharmaceutical institute is making broad recommendations meant to push that industry forward.
The year-and-a-half-old National Institute for Innovation in Manufacturing Biopharmaceuticals, or NIIMBL, has its headquarters in Newark. The institute’s recently published roadmaps seek to unite stakeholders and enhance the manufacturing capabilities of biological medicine across the industry.
Biopharmaceuticals are medicines with living cells. They are used to treat and prevent some of the most debilitating diseases.
NIIMBL Associate Institute Director Chris Roberts says there’s typically a 10 to 15-year lag between the early stages of discovery and launching a new biopharmaceutical product.
He says the roadmaps provide ways to reduce that time, as well as the time and cost of production, to make the medicines more accessible.
“To help those new ideas, those next-generation ideas that are being worked on right now and dreamt up—ones we haven’t even thought of—to streamline how quickly and how cost-effectively those can reach the patient,” said Roberts.
NIIMBL took the lead in publishing the roadmaps but was joined in the process by biomanufacturers, academics and scientists from federal agencies.
The roadmaps offer technical improvements in manufacturing. They also encourage regulators and biopharma companies to communicate early in the development process to avoid possible roadblocks later.
Each document addresses one product line to include vaccines, gene therapies and bi-specific antibodies and antibody-drug conjugates.
Roberts describes each as its own separate modality.
“Those types of medicines have their own technical challenges, but these roadmaps really help to identify what the, sort of, low-hanging fruit is and also what the longer term, larger investments are going to need to be and in what areas,” said Roberts.
The roadmaps also discuss workforce development and training needs in the biopharma industry.
NIIMBL and the University of Delaware broke ground last year on a new $156 million biopharmaceutical building at the university’s STAR campus. It’s expected to open in 2020.
Both NIIMBL and university officials say the new development will create jobs in Delaware.