Peptide-based therapeutics, especially GLP-1 agonists, have become essential tools in treating chronic diseases like type 2 diabetes and obesity. But behind their clinical promise lies a manufacturing challenge since peptide production is complex, sensitive to scale, and often resource-intensive.
At TAPI, we’ve turned this into an opportunity.
By embedding Process Analytical Technology (PAT) into every step of the peptide manufacturing process, we’ve developed a smarter and greener platform—already implemented at GMP scale—that elevates process control, accelerates timelines, and reduces environmental footprint.
This innovation is a model for how we support CDMO partners with demanding peptide programs.
A Holistic, Data-Driven Approach
Peptide manufacturing is inherently intricate, with limited in-process monitoring options and high sensitivity to deviations. Our cross-functional R&D and engineering teams tackled these challenges head-on by implementing a comprehensive PAT framework across synthesis, purification, concentration, and lyophilization.
Application of such real-time PAT tools include:
1. Refractive Index (RI) and ultraviolet spectroscopy (UV) monitoring in Solid Phase Peptide Synthesis (SPPS): Used during coupling and deprotection, RI detects deviations in reaction completeness or reagent flow, while UV confirms Fmoc removal via characteristic absorbance. Together, they provide real-time insight into reaction progress and enable early intervention, improving sequence integrity.
2. Conductivity monitoring in wash steps: In-line conductivity sensors measure residues and by products species such as dibenzylfulvene (DBF) and piperidine during resin washing, allowing dynamic wash control based on predefined thresholds. This eliminates unnecessary solvent use and enables DMF recirculation without compromising quality.
3. Near-Infrared (NIR) spectroscopy for piperidine residue monitoring: NIR enables in-line quantification of residual piperidine, ensuring effective washing before each coupling step. This improves process readiness while reducing DMF use.
4. Conductivity and NIR in downstream purification: Conductivity monitoring controls buffer preparation via in-line dilution and defines wash endpoints during desalting and ion-exchange. NIR enhances robustness, and in some cases serves as a real-time control for acetonitrile gradient accuracy in HPLC.
5. UV monitoring in continuous concentration on a Wiped Film Evaporator (WFE): UV-based PAT tracks peptide concentration during evaporation using WFE (wiped film evaporation). Initially applied as at-line IPC, this was upgraded to in-line UV, achieving concentrations up to 100 mg/mL for GLP-1 peptide. This enabled efficient lyophilization while maintaining product homogeneity.
6. Pressure monitoring in lyophilization. Dual pressure sensors (Pirani and Barocel) define robust drying endpoints independent of scale or load. This prevents overdrying, which was previously linked to peptide aggregation, ensuring product stability and process consistency.
The result? Shorter cycle times, enhanced robustness, and right-first-time production—crucial benefits in a field where variability has long been the norm.
Proven at Scale, Ready for Partnership
This isn’t a lab-scale concept. Our PAT-enabled platform is fully operational in GMP manufacturing and has already demonstrated a measurable impact:
- Reduced solvent and energy use
- Minimized human error through real-time monitoring
- Enhanced product consistency across batches and scales
- A digital foundation for future AI and machine-learning integration
Whether you’re looking to de-risk development, scale a late-phase peptide, or secure long-term commercial supply—TAPI brings proven capabilities, advanced infrastructure, and CDMO flexibility to the table.
The TAPI Advantage for Complex Peptides
With decades of peptide experience, dual-site GMP capacity in Israel and Croatia, and modular technologies (SPPS, LPPS, hybrid), TAPI is uniquely equipped to support partners from early development to commercial launch.
As a CDMO, we don’t just offer capacity, we offer chemistry innovation, analytical depth, and strategic thinking. Our teams understand the nuances of peptides and work with you to design scalable, sustainable processes that meet your molecule’s specific needs.
Partner with TAPI for Your Peptide CDMO Needs
From GLP-1 agonists to custom sequences, we’re redefining what’s possible in peptide manufacturing. If you’re seeking a partner who blends cutting-edge technology with reliable execution, let’s talk.
Contact us to explore how TAPI can support your next peptide program.
