Orocidin develops novel cGMP manufacturing process in collaboration with Syngene

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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 99% and a single maximum impurity of less than 1%.

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 50%. Improved solubility enabled smoother purification, and a tailored single-step reverse-phase HPLC purification process was established, resulting in a final peptide purity exceeding 99%, with a single maximum impurity of 0.4% and total impurities of 0.6%.

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 10%. It demonstrated reproducibility and consistency in line with clinical requirements while highlighting Syngene’s role in developing scalable GMP peptide production methods.

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 100% of Orocidin A/S, a Danish preclinical-stage biotech company developing next-generation therapies for periodontitis and 100% of Bio-Convert A/S, a Danish preclinical-stage biotech company dedicated to revolutionizing the treatment of oral leukoplakia. For more information about Nordicus, please visit: www.nordicuspartners.com, and follow us on LinkedIn, X, Threads and BlueSky.

Cautionary Note Regarding Forward-Looking Statements:

This press release may contain forward-looking statements that involve substantial risks and uncertainties. You can identify these statements by the use of forward-looking terminology such as “may,” “will,” “should,” “expect,” “anticipate,” “project,” “estimate,” “intend,” “continue,” “confident” or “believe” or the negatives thereof or other variations thereon or comparable terminology. You should read statements that contain these words carefully because they discuss our plans, strategies, prospects and expectations concerning our business, operating results, financial condition, prospects of being listed on Nasdaq and other similar matters. We believe that it is important to communicate our future expectations to our investors. There may be events in the future, however, that we are not able to predict accurately or control. Any forward-looking statement made by us in this press release speaks only as of the date on which we make it. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. 

For further information, contact:
Mr. Henrik Rouf
Chief Executive Officer
hr@nordicuspartners.com
Tel +1 310 666 0750

FAQ

What did Orocidin (NORD) announce on October 20, 2025 about QR-01 manufacturing?

Orocidin announced a developed cGMP-compliant manufacturing process for QR-01 in collaboration with Syngene, producing material for a Phase IIA study.

What purity and impurity levels did Orocidin achieve for QR-01 (NORD)?

The final QR-01 peptide achieved >99% purity with a single maximum impurity of 0.4% and total impurities of 0.6%.

Does Orocidin (NORD) have cGMP material to start clinical trials for QR-01?

Yes. Orocidin completed first production of cGMP material intended to allow initiation of a Phase IIA pilot efficacy study.

What manufacturing yield did Orocidin report for QR-01 cGMP production (NORD)?

Orocidin reported an overall cGMP manufacturing yield of 10% after scaling the process.

What technical challenges did Orocidin and Syngene address producing QR-01 (NORD)?

They addressed sequence-induced aggregation, incomplete coupling/deprotection, poor solubility, oxidation sensitivity, and purification aggregation.