Dutch contract development and manufacturing organisation (CDMO), BioConnection, is focusing on good manufacturing practice (GMP) services for biopharmaceutical developers.
Amid the booming biologic treatments and cell and gene therapies developments space, with over 1,000 ongoing clinical trials worldwide, the company suggests that developers in early stages should reserve a slot to manufacture their product.
“Arranging a partnership with a contract manufacturing organization can be challenging because the market currently is rather occupied,” Michel Croes, program and business development manager for BioConnection, told us, adding that the company has received orders until Q3 of 2020.
“Developers need to talk with their CMO earlier in the process in order to reserve capacity and time,” Croes told us, explaining the importance of prioritizing manufacturing services over other processes while moving forward in drug development.
According to the company’s executive, before drug developers enter the clinic, “they usually reserve funding from investors, then they ensure the drug options through substance manufacturers, and afterwards they talk with contract research organizations to plan their trials.”
Croes added that by the time developers approach the manufacturers to ensure their supply, most CDMOs are ‘occupied,’ keeping developers from initiating or continuing their clinical programs.
“The simple solution to this, which doesn’t cost a lot, is to speak to a CMO early and make a reservation, so that the program won’t have to stop,” Croes told us, stating that manufacturing services providers charge a reservation fee.
Companies that do not make such a reservation, according to Croes, “end up waiting almost six months, which is a real showstopper, and costs huge investments.”
Capacity shortage
According to Croes, during the last three years the biopharmaceutical industry has seen a ‘huge’ increase in investments, as well as plenty of start-up companies joining the market.
“Big pharma is looking exponentially for smaller companies with great ideas and the acquisitions occur strategically as soon as developers get encouraging data from Phase I,” the executive noted.
“This has led to a pattern of investors funding smaller companies in order to sell them to bigger companies when they reach Phase I or Phase II,” he added.
Therefore, due to increasing demand for early-stage clinical manufacturing, the service providers have made investments in capacity expansions which, however, require time to complete. “In the meantime,” said Croes, “there is a significant shortage on the market for fill capacity.”
Compounding this challenge, the increase in new treatments entering the clinic is likely to continue, he said, noting that big pharmaceutical companies are significantly decreasing their R&D budgets and “look to buy small companies with great R&D, because they are more flexible.”
“Decisions within global companies always take a lot more time compared to smaller companies, and the time to market is very important nowadays,” Croes added, concluding that this trend is here to stay.
“Smaller companies will keep doing preliminary work on their own, before being bought by big pharma.”
