AmbioPharm, Inc. Submits IPO Prospectus as a Global Leader in Peptide Manufacturing

August 30, 2022One of the Peptide Manufacturers with the Largest Global Production Capacity: AmbioPharm, Inc.(AmbioPharm) announced that it will submit an Investigational New Drug (IND) application in the fourth quarter of 2022 for OK-100, a lipopeptide analog developed in collaboration with biotechnology company OKYO Pharma Limited (OKYO) for the treatment of dry eye disease, followed by the initiation of Phase II clinical trials.

Over the past two years,AmbioPharmwith Amytrx Therapeutics, ONL Therapeutics, Adalvo, etc.Establishing Partnerships with Large Peptide Drug Development Companies, custom-developing corresponding peptide products for indications such as retinal detachment, macular degeneration, glaucoma, diabetes, immune disorders, heart disease, endocrine disorders, atopic dermatitis, herpes zoster, psoriasis, chronic pain, and hereditary angioedema.

From milligram-scale to projects exceeding 100 kg, AmbioPharm delivers higher-quality products at lower costs by streamlining chemical synthesis operations right from the source. Leveraging the review and release authority of its internal quality control department, AmbioPharm can fulfill custom non-GMP peptide orders in just 3–4 weeks.

AmbioPharm was established in 202005, but itsThe management team has accumulated over 200 years of experience in peptide development and manufacturing.。AmbioPharmDr. Juncai Bai, Executive Director, Founder, Chairman of the Board, and Chief Executive OfficerResponsible for process development, scale-up, and cGMP manufacturing of peptide products. His involvement in peptide process development includes liquid-phase chemical process development and the 40 kg-scale manufacturing of a 22-amino acid peptide product.

Dr. Bai Juncai

Dr. Mike Pennungton, Chief Scientist at AmbioPharmDr. Mike has dedicated his career to the research and development of peptides, having published over 130 scientific papers on the synthesis and development of therapeutic peptides for human diseases. At AmbioPharm, Dr. Mike is primarily responsible for providing technical guidance in the contract manufacturing of synthetic peptides, PEGylated peptides, and peptide-protein conjugates, with projects covering GMP, non-GMP, and clinical trial applications.

Dr. Mike Pennungton

AmbioPharm is currently inSouth Carolina, USA (Headquarters)andShanghai, ChinaEquipped with a manufacturing plant, itsAll development and manufacturing processes comply with the cGMP regulations required by the U.S. FDA., andRegularly Subject to FDA Review. A total of bilateral factoriesEmploys nearly 700 chemists and industry professionals, providing production, customization, and testing services for GMP, non-GMP, general-purpose peptides, vaccine-active peptides, cosmetic peptides, and other products to clients including biotechnology companies, pharmaceutical companies, clinical research laboratories, daily chemical companies, and food companies.

The facility in South Carolina has recently completed its expansion, now offering approximately 7,670 square meters of manufacturing space that includes capabilities for purification, lyophilization, quality control, and microwave-assisted solid-phase peptide synthesis (SPPS). In Shanghai, China, more than 375 chemists and staff members are vigorously advancing peptide synthesis and manufacturing operations. Currently, an advanced manufacturing building spanning over 26,000 square meters is under construction; once operational, it will more than double synthetic capacity and add six new large-scale production lines.

South Carolina Plant (Headquarters), USA, and Shanghai Plant, China

AmbioPharm has established a partnership with manufacturers of amino acid derivatives and solvent raw materials,Producing the highest-quality peptide products at the lowest cost in the industry. ThroughConduct large-scale purchasing at the upstream source to reduce costs, more importantly, AmbioPharm has establishedSolvent Recovery System, capable ofReduce manufacturing costs by approximately 50%, whileReduce Solvent Waste, achieving sustainabilityGreen Production。

AmbioPharm is also one of the world's largest custom GMP peptide manufacturers., capable of providing customized peptide products of any scale and type.Depending on the project, AmbioPharm usesSolid-Phase Peptide Synthesis (SPPS)、Liquid-Phase Peptide Synthesis (LPPS)andSynthesis of Hybrid Solid-Liquid Phasesmethods for producing corresponding peptide products. AmbioPharm operates 30 solid-phase reactors and 20 liquid-phase reactors, with capacities ranging from 1 L to 5,000 L; its high-performance liquid chromatography (HPLC) columns range in diameter from 5 cm to 100 cm, enabling purification scales from 1 g to 30 kg.

In accordance with GMP regulationsAmbioPharm provides customers with research and development, custom synthesis, and purification validation services for peptides, organic compounds, and bioactive peptides. Bioactive peptides typically exhibit analgesic, antidiabetic, anti-hormonal, antibacterial, anti-inflammatory, antioxidant, antihypertensive, antithrombotic, and laxative effects. The bioactive peptides that AmbioPharm can manufacture include, but are not limited to, antimicrobial peptides, host defense peptides, cell-penetrating peptides, enzyme inhibitors, GLP-1, GLP-2, hepcidin, neuropeptides, and RGD peptides. These peptides feature low toxicity and high specificity, and are commonly used in the production of pharmaceuticals, food products, cosmetics, and veterinary drugs, as well as in medical diagnostics.

In 2021,AmbioPharm and CEM Corporation, a Global Leading Supplier of Laboratory Instruments(hereinafter referred to as “CEM”) establish a partnership.CEM Offers Its Microwave Solid-Phase Peptide Synthesis System, integrating microwave synthesis technology into AmbioPharm's GMP peptide manufacturing, inImproving Peptide Product PuritywhileSignificantly reduce the required reagents and materials.More importantly, through the optimized coupling method for high-temperature reactions in this system, it is possible toEnabling the Manufacturing of Longer and More Complex Peptide Products。

In addition to manufacturing peptide products in accordance with GMP standards, AmbioPharm alsoProcess Development and Analytical Services for Non-GMP or GLP-Grade Peptide Products. These products have a broader target audience, which can include universities, research institutions, biotechnology companies, and pharmaceutical companies. In addition to supporting product research at various scales, AmbioPharm also provides customers with additional analytical and storage services.

AmbioPharm is a manufacturer of generic peptide active pharmaceutical ingredients (APIs) and a highly efficient, high-quality CDMO. AmbioPharm also collaborates with generic drug companies to develop generic peptide drugs for established global commercial markets.

As part of AmbioPharm’s vaccine services, the company brings over a decade of experience in manufacturing active peptide components for various peptide vaccines. In addition to producing high-quality, high-value peptide products in strict compliance with cGMP standards, AmbioPharm also provides expert guidance in three key areas: product analysis, process development, and production oversight.

As an experienced CDMO specializing in active pharmaceutical ingredients, AmbioPharm operates cosmetic peptide production lines of appropriate scale. Leveraging its expertise in all types of peptide synthesis—from solid-phase to liquid-phase or hybrid solid-liquid methods—AmbioPharm is capable of synthesizing cosmetic peptide ingredients ranging from the simplest to the most complex structures.

While developing peptide products, AmbioPharm alsoUsing High-Performance Liquid Chromatography (HPLC)andUltra-Performance Liquid Chromatography (UPLC)Develop correspondingAnalysis and Validation Tool。

These tools enable monitoring of side reaction processes and purity standards, while limiting any related residual substances in the product. By controlling the quality of the final active pharmaceutical ingredient (API), AmbioPharm minimizes manufacturing steps and product degradation. This provides formulators with the longest possible labeled drug shelf life under appropriate storage conditions.

Product DevelopmentIn this regard, AmbioPharm utilizes both HPLC and UPLC methods to isolate related substances and degradation products in key products, and provides reports on method development.Method ValidationIn this regard, AmbioPharm utilizes both HPLC and UPLC to develop analytical method validation protocols, execute analytical method validation, and provide method validation reports.

AmbioPharm demonstrates unparalleled advantages across all dimensions, including capabilities, experience, financial strength, quality, functionality, and global reach.

Building on its existing high-quality, high-capacity technologies, AmbioPharm is now committed to expanding socially and environmentally responsible, cost-effective operations, thereby enhancing environmental stewardship and respect. Its commitment and contributions to the environment have become an integral part of its management structure, manufacturing processes, and corporate culture.

From September to December, AmbioPharm’s professional sales and technical representatives will attend peptide- and life science-related seminars in China, the United States, the United Kingdom, Germany, Japan, Austria, and other countries around the world, providing additional insights for peptide drug development.