API Manufacturing | Peptides APIs

Delivering Your Fundamental APIs for Drug Development

Few decisions in pharmaceutical operations are as critical as selecting the right cGMP contract manufacturer to produce your Active Pharmaceutical Ingredient (API). As your CDMO partner, CordenPharma brings decades of API development and manufacturing experience to deliver the high quality Drug Substance you need for the success of your project.

CordenPharma’s understanding of the development process, and access to resources throughout its network of facilities, allow for the fast and reliable supply of APIs. We provide seamless technology transfer from research laboratories to our integrated network of commercial cGMP manufacturing facilities, with capabilities including:

Diverse reactor capacity ranging from 20 L to 28,000 L
Comprehensive asset classes across small molecules, peptides, and oligonucleotides
Variable potencies extending down to exposure limits of 1 ng/m³

With state-of-the-art facilities and a dedicated team of project management experts, our comprehensive API services are tailored to meet your specific pharmaceutical development and production requirements. Benefit from our extensive infrastructure, with proven experience in producing commercial products that are distributed into worldwide regulated markets.

Peptides
Oligonucleotides
HPAPIs
Small Molecules

Peptides

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Need complex peptide APIs for your final drug product? Our scientists have mastered the core principles of synthesizing advanced peptide APIs, and bring them to bear on every project, large or small. The CordenPharma Peptides technology platform delivers specialized expertise across multiple cGMP facilities in our integrated network, from early stage to commercial supply of advanced peptide APIs.

Oligonucleotides

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Need high quality oligonucleotides for your oligo-based drug? We draw upon decades of experience in solid-support assisted manufacturing, along with extensive purification capabilities to support your oligonucleotide manufacturing projects. Our expert chemistry teams design and produce custom oligos tailored to your specific quality standards, and deliver them through the Oligonucleotides technology platform. From DNA to RNA to modified nucleotides and backbones, we supply sequences of various lengths and complexity.

HPAPIs

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Need expertise in highly potent containment manufacturing? With over 30 years of experience in the development and production of highly potent APIs (HPAPIs), the extensive capabilities and expert teams of our Highly Potent & Oncology technology platform apply a profound understanding of highly potent containment manufacturing to supply clinical to commercial HPAPIs tailored to your requirements. Our API facilities can scale up from laboratory scale to 12,000 L vessels, and handle compounds of potency down to below 1ng/m³.

Small Molecules

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Need a reliable small molecule supplier with ample capacity? The heart of our API manufacturing expertise remains our Small Molecules technology platform. With a combined 200+ years of manufacturing knowledge, our integrated facility network provides over 1.2 million liters of volumetric capacity, with reactors ranging from 20 L to 28,000 L. We are the CDMO partner you need for high quality small molecule APIs at all scales, be it grams to metric tons.

API Services

Producing the final commercial API at the appropriate scale is just one part of the journey. Through years of experience supplying complex APIs, CordenPharma has targeted and developed specialized API support services to make your API project journey run as smoothly and successfully as possible. From continuous manufacturing utilizing expert flow chemistry and enhanced purification methods, to identifying, developing and obtaining the best solid state API crystalline form, we support customers with full analytical, validation and regulatory services at all phases of development.

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Flow Chemistry

Continuous manufacturing, and in particular flow chemistry, remains a highly attractive technology option for pharmaceutical and biotech innovators. Although slightly more expensive upfront costs are required to establish the methodology, the long-term savings from reduced manufacturing costs and eliminated scale-up and development cycles, as well as greater scale and manufacturing flexibility, can far outweigh larger starting costs. The inherent de-risking potential of this technology offers significant cost-saving and a valuable strategy for mitigating risks in your operations.

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Solid State

Identifying, developing, and obtaining the best crystalline form of an API is crucial in drug development. It has a significant impact on the effectiveness of the drug product formulation and bioavailability of the finished dosage form. Our Solid State Centre of Excellence is a dedicated resource of experts to support your API projects with crystallization investigations such as solubility tests, salt screening, polymorphism screening, and optimization of crystallization processes, to address the critical parameters needed to deliver the most suitable crystalline form of your API.

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Purification

Ensuring the effective purification of your API is fundamental to a successful scale-up, efficient commercialization, and a secure supply chain. Our purification services span a wide range of scales (from grams to multi 100 kgs), and phases (from Phase 1 to commercial manufacturing), with solutions including reverse and normal phase preparative chromatography, Supercritical Fluid Chromatography (SFC), and Tangential Flow Filtration (TFF). We work with you to tailor an optimal purification program based on your objectives and goals, at every stage of the drug development cycle.

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Speed to Market
Quality and Compliance
Flexibility and Transparency

Speed to Market

In pharmaceutical development money is time, and time is of the essence. We understand the urgency of producing critical medicines, and are here to support the management of your supply chain timelines, regardless of the development phase. Our expert teams have decades of experience using cutting-edge technologies across our integrated facility network to help bring your complex modalities to market quickly.

Quality and Compliance

Quality is the most important ingredient for therapeutic effectiveness, and thus, commercial success. Our commitment to seek the highest standards of quality and compliance is at the core of CordenPharma. By continuing to invest heavily in ongoing compliance programs with budgeted investments in improvements such as compliance-enhancing IT solutions, we make no compromises in this area. Our objective is to not only meet, but surpass applicable regulatory requirements and legislations to provide services that elevate and ensure product integrity for you and the patients you serve.

Flexibility and Transparency

Navigating through your drug development lifecycle can present challenges. CordenPharma understands that a successful CDMO / pharma innovator partnership requires regular touchpoints of insight, feedback and alignment along the way. With this in mind, we have made a collaborative commitment across the entire organization, from executive leadership and project management teams to facility operators, to react with flexibility and transparency to your changing needs and strive every day to steer your project towards our common goal: the health and well-being of your patients.