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Integrated support across drug substance and drug product development

Peptide CMC Solutions

An integrated CMC approach is essential for advancing peptide candidates efficiently toward the clinic. Our capabilities combine scalable peptide synthesis and purification with formulation development to maintain continuity across CMC stages and reduce technology-transfer complexity.

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Supporting Peptide Development from Start to Scale

BioDuro connects peptide process development, scale-up, manufacturing, and formulation so programs can move forward with fewer handoffs. This helps teams address challenges earlier and keep development moving toward the clinic and beyond.

Seamless Transition

Early CMC considerations help reduce transition risk and support smooth progression from process development into scale-up and manufacturing.

Built for Peptide Complexity

Multiple synthesis approaches, including SPPS, LPPS, and hybrid strategies, support diverse peptide modalities, while formulation solutions address peptide-specific challenges in stability, bioavailability, and delivery.

Scalable & Reliable Delivery

Flexible drug substance scale-up supports development from early-stage programs through commercial GMP manufacturing, complemented by end-to-end unnatural amino acid capabilities and structured CMC support toward IND readiness.

Drug Substance Process Development

BioDuro develops peptide synthesis processes using SPPS, LPPS, and hybrid approaches, with strategies tailored to the structural and process requirements of each molecule.

Our process development capabilities support a broad range of peptide modalities, including linear, cyclic and macrocyclic, modified, and conjugated peptides, as well as complex chemistries involving unnatural amino acids and other structural modifications.

Scale-Up & Drug Substance Manufacturing

At kilolab scale, BioDuro translates laboratory processes into manufacturing-ready workflows, integrating synthesis and purification to address scale-dependent challenges early and facilitate efficient technology transfer into GMP production.

Commercial GMP manufacturing extends this process knowledge into large-scale production, preparative purification, and downstream operations, helping preserve process robustness and product quality while enabling reliable supply as programs advance.

Drug Product Development

Peptide formulation development requires strategies tailored to the molecule’s physicochemical properties and intended delivery route. BioDuro addresses key peptide development challenges through formulation and product development approaches.

Poor Oral Bioavailability

Permeation enhancers, pH modulation, lipid-based delivery systems, ASD, particle size reduction, and site-specific delivery strategies.

Chemical & Physical Instability

pH optimization, excipient screening, oxygen/light control, lyophilization, and formulation screening to improve storage stability.

Aggregation & Adsorption Risk

Surfactant selection, ionic strength adjustment, container-closure compatibility, and control of bubbles, silicone oil, and shear stress.

Decision Uncertainty

Concentration and viscosity optimization, device compatibility assessment, injection force evaluation, and dose accuracy support.

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QA & EHS RSM and Intermediates Kilo and Pilot Scale API High Potency API GMP API Manufacturing API Manufacturing Drug Substance Manufacturing Pre-formulation Formulation Development Stability Studies QC Testing & Release Route Scouting & Optimization Process Safety Assessment Preparative Purification Capacity Peptide Chemistry Sugar Chemistry Flow Chemistry Process R&D