Orocidin develops novel cGMP manufacturing process in collaboration with Syngene
Orocidin (OTCQB: NORD) announced development of a cGMP-compliant manufacturing process for QR-01, a 37-amino-acid peptide intended as a potential treatment for aggressive periodontitis, in collaboration with Syngene on October 20, 2025.
Key technical outcomes include a tailored SPPS approach, crude peptide purity >50%, final purity >99%, single maximum impurity of 0.4% (total impurities 0.6%), and a reproducible cGMP process with an overall yield of 10%. The produced cGMP material enables initiation of a planned Phase IIA pilot efficacy study in humans.
Orocidin (OTCQB: NORD) ha annunciato lo sviluppo di un processo di produzione conforme alle cGMP per QR-01, un peptide di 37 amminoacidi concepito come potenziale trattamento per la parodontite aggressiva, in collaborazione con Syngene il 20 ottobre 2025.
Risultati tecnologici chiave includono un approccio SPPS su misura, purezza del peptide grezzo >50%, purezza finale >99%, singola impurità massima 0,4% (impurità totali 0,6%), e un processo cGMP riproducibile con una resa complessiva del 10%. Il materiale cGMP prodotto consente l'inizio di uno studio pilota di efficacia di fase IIA pianificato sull'uomo.
Orocidin (OTCQB: NORD) anunció el desarrollo de un proceso de fabricación conforme cGMP para QR-01, un péptido de 37 aminoácidos destinado a ser un posible tratamiento para la periodontitis agresiva, en colaboración con Syngene el 20 de octubre de 2025.
Los resultados técnicos clave incluyen un enfoque SPPS a medida, pureza del péptido crudo >50%, pureza final >99%, una única impureza máxima de 0,4% (impurezas totales 0,6%), y un proceso cGMP reproducible con un rendimiento global del 10%. El material cGMP producido permite inicios de un estudio piloto de eficacia de Fase IIA en humanos.
Orocidin (OTCQB: NORD)은 QR-01에 대해 cGMP 준수 제조 공정의 개발을 Syngene와의 협력으로 2025년 10월 20일 발표했습니다. QR-01은 공격적인 치주염에 대한 잠재적 치료제로 의도된 37개의 아미노산 펩타이드입니다.
주요 기술적 결과로는 맞춤형 SPPS 접근법, 원료 펩타이드 순도 >50%, 최종 순도 >99%, 단일 최대 불순물 0.4% (총 불순물 0.6%), 재현 가능한 cGMP 공정 및 총 수율 10%이 포함되며, 생산된 cGMP 물질은 예정된 인간 대상 Phase IIA 파일럿 효능 연구의 시작을 가능하게 합니다.
Orocidin (OTCQB: NORD) a annoncé le développement d'un processus de fabrication conforme cGMP pour QR-01, un peptide de 37 acides aminés destiné à être un traitement potentiel pour la parodontite agressive, en collaboration avec Syngene le 20 octobre 2025.
Les résultats techniques clés incluent une approche SPPS sur mesure, une pureté du peptide brut >50%, une pureté finale >99%, une impureté unique maximale de 0,4% (impuretés totales 0,6%), et un processus cGMP reproductible avec un rendement global de 10%. Le matériel cGMP produit permet le démarrage d'une étude pilote d'efficacité de phase IIA chez l'humain.
Orocidin (OTCQB: NORD) kündigte die Entwicklung eines cGMP-konformen Herstellungsprozesses für QR-01 an, ein 37-Aminosäuren-Peptid, das als potenzielle Behandlung für aggressive Parodontitis gedacht ist, in Zusammenarbeit mit Syngene am 20. Oktober 2025.
Zu den technischen Hauptergebnissen gehören ein maßgeschneiderter SPPS-Ansatz, rohe Peptidreinheit >50%, Endreinheit >99%, eine einzelne maximale Verunreinigung von 0,4% (Gesamtverunreinigungen 0,6%), und ein reproduzierbarer cGMP-Prozess mit einer Gesamtausbeute von 10%. Das produzierte cGMP-Material ermöglicht den Beginn einer geplanten Phase-IIA-Pilotwirksamkeitsstudie am Menschen.
Orocidin (OTCQB: NORD) أعلن عن تطوير عملية تصنيع متوافقة مع cGMP لـ QR-01، وهو ببتيد مكوَّن من 37 حمض أميني مقصود أن يكون علاجاً محتملاً لأمراض اللثة الشديدة، بالتعاون مع Syngene في 20 أكتوبر 2025.
تشمل النتائج الفنية الرئيسية نهج SPPS مُخصص، نقاء الببتيد الخام >50%، النقاء النهائي >99%، وجود شوائب فردية قصوى 0.4% (إجمالي الشوائب 0.6%)، وعملية cGMP قابلة لإعادة الإنتاج مع عائد إجمالي قدره 10%. المادة المُنتَجة وفق cGMP تتيح البدء في دراسة نموذجية من المرحلة IIA لاختبار الفاعلية على البشر.
Orocidin (OTCQB: NORD) 宣布开发了用于 QR-01 的 符合 cGMP 的制造工艺，QR-01 是一个由 37 个氨基酸组成的肽，旨在作为治疗侵袭性牙周炎的潜在治疗方案，与 Syngene 合作于 2025 年 10 月 20 日公告。
关键技术成果包括定制的 SPPS 方法、粗肽纯度 >50%、最终纯度 >99%、单一最高杂质 0.4%（总杂质 0.6%）、以及可重复的 cGMP 工艺，总产率为 10%。所生产的 cGMP 材料使得启动计划中的 IIA 阶段人用初步疗效研究成为可能。
- Final peptide purity >99% meeting clinical target
- Single maximum impurity measured at 0.4% (total impurities 0.6%)
- cGMP material produced enabling planned Phase IIA human study
- Successfully transitioned small-scale process to reproducible cGMP manufacturing
- Overall cGMP manufacturing yield of 10% may constrain batch output
- QR-01 showed aggregation, poor solubility, and oxidation sensitivity during development
The partnership addressed complex peptide synthesis and purification challenges to achieve high yield and purity suitable for clinical use
BEVERLY HILLS, California, Oct. 20, 2025 (GLOBE NEWSWIRE) -- Orocidin A/S (“Orocidin”), a subsidiary of Nordicus Partners Corporation (OTCQB: NORD) (“Nordicus” or the “Company”), a financial consulting company specializing in supporting Nordic and U.S. life sciences companies in establishing themselves in the U.S. market, announced the development of a unique, cGMP-compliant manufacturing process. The program was executed in partnership with Syngene International Limited (“Syngene”), a leading integrated research, development, and manufacturing services organization.
QR-01 is an 37-amino acid (37-mer), cationic, amphipathic peptide designed to target and eliminate harmful bacteria, representing a potential treatment for advanced gum disease, or aggressive periodontitis. To advance QR-01 into clinical trials, Orocidin required the production of a peptide suitable for human use, with a target purity of greater than
Orocidin has completed the first production of cGMP material that will allow Orocidin to initiate the first human pilot efficacy study in patients (a Phase IIA study).
Addressing the manufacturing challenge
The development of this complex 37-mer peptide posed several technical challenges due to its chemical characteristics. Rich in hydrophobic and basic amino acids, QR-01 was prone to aggregation during Solid-Phase Peptide Synthesis (SPPS), resulting in incomplete coupling and low crude yield. The N-terminal region, containing multiple lysine and arginine residues, was susceptible to incomplete deprotection and side reactions. Additionally, the peptide exhibited poor solubility, high oxidation sensitivity, and a tendency to form aggregates during purification.
To overcome these challenges, a customized synthesis and purification process was developed in collaboration with Syngene’s chemical development team. A low-loading resin approach was implemented during SPPS to minimize sequence-induced aggregation, while optimization of the chemical cleavage step prevented the formation of TFA adducts. This refinement yielded a crude peptide purity greater than
Seamless transition to cGMP manufacturing
“We were very impressed with Syngene’s professionalism, commitment to scientific excellence, and ability to deliver high-quality work on time. This partnership work was the result of a strong and fruitful collaboration between Orocidin and Syngene by utilizing the highly skilled scientists and state-of-the-art facilities from Syngene to facilitate the development and progress of Orocidin’s QR-01,” said Allan Wehnert, CEO and Founder of Orocidin.
Following the successful completion of small-scale synthesis, the process was transitioned to cGMP manufacturing, achieving an overall yield of
About Orocidin
Orocidin’s mission is to develop the preferred treatment against aggressive periodontitis. Our innovative therapeutic agent, QR-01, distinguishes itself through its unique ability to provide treatment of both inflammation and bacterial infection.
About Nordicus Partners Corporation
Nordicus Partners Corporation is the only U.S. publicly traded business accelerator and holding company for Nordic life sciences companies. Leveraging decades of combined management experience in domestic and global corporate sectors, Nordicus excels in corporate finance activities including business and market development, growth strategies, talent acquisition, partnership building, capital raising, and facilitating company acquisitions and sales. In 2024, Nordicus acquired
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For further information, contact:
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hr@nordicuspartners.com
Tel +1 310 666 0750
FAQ
What did Orocidin (NORD) announce on October 20, 2025 about QR-01 manufacturing?
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