Case Study on GMP Process Development of DOTAGA-Labeled Peptide & POC Products
Presentation at TIDES US 2024
Tim Nieters, MBA (Senior Vice President of Strategic Portfolio Development) presented a case study at TIDES USA 2024 in Boston, MA, covering process development of GMP DOTAGA-labeled peptide and POC-based products.
Peptides are advantageous as therapeutic vectors in PRRT due to their small size, favorable pharmacokinetics, high binding affinity, low immunogenicity and toxicity, and minimal off-target binding.
This case study presents a manufacturing process for DOTAGA-Labeled urea-based peptide PSMA inhibitor API, DOTAGA-(I-y)fk(Sub-KuE). Multigram-scale process development and GMP manufacturing was completed in only ten months. Through optimized synthesis, cleavage, and purification an overall yield of >65% (>98% purity) was achieved.
Dive into Joseph Denby's presentation at NextGen Biomed 2026, where he shares a case study on delivering sustainable, efficient peptide manufacturing at scale through our advanced SPPS process optimizations.
Construction begins on CPC Scientific’s 41,000 sq ft building in Rocklin to establish a new Center of Excellence for Peptide Manufacturing.
Join us as we celebrate a proud milestone: the successful listing of Medtide Inc., parent company of CPC Scientific, on the Hong Kong Stock Exchange!
Sheri Ambriz, MBA took the stage at TIDES USA 2025 in San Diego, CA, to share insights on green approaches to peptide and peptide–oligonucleotide conjugate manufacturing.
Gain insights from Joseph Denby's rapid-fire Q&A spotlight at NextGen Biomed 2025, where he explores the landscape of peptide and oligo APIs, as well as the role of green chemistry in manufacturing.
Backed by nearly 25 years of dedicated service to the pharmaceutical industry, CPC Scientific is a CRDMO specializing in synthetic peptide manufacturing for early-phase, late-phase development, and commercial production with metric-ton scale GMP API capacity...
We ensure the highest quality standards for late-stage and commercial API manufacturing, following comprehensive CGMP guidelines and testing protocols. We provide complete regulatory support for your IND and NDA filings in the USA and all international filings, ensuring global compliance...
CPC Scientific offers a variety of generic peptides used as active pharmaceutical ingredients. With our expertise in ANDA and NCE development, including DMF preparation, NDA submissions, and full regulatory support, we provide efficient and reliable pathways for API regulatory approval.
CPC Scientific combines cutting-edge technology with metric-ton scale API capacity, with annual production capacity of over 1000 kg and per-batch capacity of 20–25 kg. Our pre-qualified workspace allows us to initiate API production sooner than most peptide manufacturers...
We offer both research-grade and clinical-grade oligonucleotide manufacturing services. Using solid-phase synthesis, we provide custom oligo development, scale-up, and analytical testing, supporting clients across the entire lifecycle from early discovery through clinical stages...
As a leading GMP-compliant peptide and oligo manufacturer based in the USA, CPC Scientific treats each program as a true partnership. With our client-first project management approach, we provide complete lifecycle support at every stage, combining personalized project leadership with the seamless coordination needed to scale...
