Japanese pharmaceutical companies are engaging CDMOs earlier in the development cycle, as increasing complexity in peptide programs places greater strain on in-house capabilities, according to officials at Neuland Laboratories, which is attending CPHI Japan this week. The company says it has seen a notable shift in demand over the past 12–24 months, with more early-stage programs seeking external support.
This trend is being driven in part by growing activity from venture-backed biotech companies and spinouts emerging from large pharmaceutical R&D organizations, reports a Neuland spokesperson, who adds that as these programs advance into clinical development, demand for specialized CDMO capabilities is increasing.
Neuland has observed a rise in peptide-related engagements from Japanese companies, particularly at the preclinical and early clinical stages, where technical requirements are more demanding, notes Sharadsrikar Kotturi, PhD, CSO at Hyderabad, India-based Neuland Labs.
Peptide development presents several challenges compared with traditional small molecules, explains Kotturi. Analytical complexity remains a key issue, with structural characteristics making characterization, impurity detection, and purity assessment more difficult, he continues. Scaleup is also constrained by the availability and quality of protected amino acids, which can affect manufacturing timelines, cost, and overall success rates.
Regulatory expectations further add to the burden, points out Kotturi. Demonstrating purity, consistency, and process control to authorities such as Japan’s Pharmaceuticals and Medical Devices Agency requires extensive data, while shifting requirements introduce additional hurdles during development and approval. Simultaneously, pricing and regulatory pressures in Japan are increasing the operational load on drug developers, he states. Frequent drug price revisions are pushing companies to improve cost efficiency, reinforcing the case for outsourcing.
“The bottleneck isn’t discovery anymore. It’s execution,” says Kotturi. “In peptides, programs are running into challenges around analytical complexity, scaleup, and the availability of key raw materials such as protected amino acids.”
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