The pharmaceutical industry has the reputation of being resistant to change. The prevailing wisdom is that drug companies are unwilling to invest in unproven manufacturing technologies because of the high cost of validating them.
And, although the pandemic has seen more firms adopt innovative systems, “investing at risk” is still a new idea for most companies involved in drug production.
The contract manufacturing sector is the exception. A successful CDMO is one that can complete multiple customer projects quickly and for the right price. As a result, contractors have always invested in innovative methodologies to keep pace with evolving demand.
This trend is accelerating, according to ABI Research analyst Michael Larner, who authored a report on the CDMO sector’s digital transformation. He says CDMOs are investing in digital technologies because to work with multiple customers more effectively.
“Like in the electronics markets, contract drug manufacturers have a key role when it comes to bringing products to market,” he explains. One of the biggest challenges for these types of manufacturers is re-configuring the production line from one client to another. And also introducing continuous manufacturing rather than spending time switching from one batch to another.”
Larner says although current cGMP regulations require that manufacturers have well-documented SOPs, many still collect and store data on paper, which increases the likelihood errors are made.
“As a result there is a growing need for contract manufacturers to create digital threads tying together all the information relating to a drug from the lab, to the production line, supply chain and patient,” he tells GEN.
The need to keep track of multiple manufacturing projects is particularly important for CDMOs that are involved in the production of personalized medicines, according to Larner.
“Pharmaceutical firms will be able to create drugs and medicines that are a tailored to the individual’s needs” he continues. “This development will require manufacturers to convert production lines to a more individualized process driving investments in production planning and recalibrating the machinery on the shop floor.”
Fighting fakes and hackers
Digital technologies also have a role to play in helping CDMOs and their customers secure supply chains and manufacturing operations. Larner points out that regulators, governments, and patients need to trust the quality, efficacy, and authenticity of the drugs and vaccines being produced, which means any contract manufacturers involved must protect their operations.
“There is a need to eliminate counterfeit drugs from the supply chain before they reach patients is a critical priority. The Drug Supply Chain Security Act (DSCSA) focuses on improving transparency in drug supply chain,” he continues. “Allied to the previous point, computer viruses are mutating, and contract manufacturers need to invest in security software to shore up their networks.”
Larner maintains that cross industry collaboration will help CDMOs and the biopharmaceutical industry make the best use of digital manufacturing technologies, from both a product quality and data management standpoint.
“BioPhorum is the best example of industry wide collaboration between manufacturers and technology suppliers,” he says. “The BioPhorum digital maturity model helps both parties to understand the types of investments required to move from a pre-digital to fully adaptive plant.”