Corden Pharma International GmbH

Your Expert Partner for Standard & Proprietary Lipids & Carbohydrates

• >> A specialized Lipids offering including custom and standard lipids (Glycero-Phospholipids, Sphingolipids, Phosphocholine, Pegylated, and Cationic Lipids).
• >> Lipids for support of mRNA vaccine production including Phosphocholine, Pegylated, Cationic Lipids and highly pure plant-based CP BotaniChol® (cholesterol).
• >> Fully-integrated service offering > from APIs to finished dosage and pharmaceutical services (clinical trial kits preparation, randomization and logistics).
• >> Backward integration for key starting materials > securing the supply chain in terms of costs & quality.
• >> Multiple manufacturing locations across Europe & the USA offering flexibility of supply.

Your Expert Partner for Peptide APIs

• >> Proven track record delivering world class manufacturing services from early stage to commercial supply, including complex products (e.g., Linaclotide, Enfuvirtide, Mifamurtide, Eptifibatide, Glatiramer, GLP analogues).
• >> Proprietary process technologies for cost-effective manufacturing and a robust CMC dossier by reduced chemical steps, increased purity, decreased raw material costs, and green approaches to reduce our carbon footprint.
• >> A unique expertise in Peptides offering access to a wide range of products to meet customer needs.
• >> Fully-integrated supply from peptide APIs to injectable Drug Products, with backward integration for key starting materials to secure supply chain.
• >> Multiple manufacturing locations across Europe & the USA offering flexibility of supply while supporting our Business Contingency Plan (BCP).

Your Expert Partner for Clinical & Commercial Injectable Drug Product Supply

• >> Wide & balanced range of injectable services incl. capability for combining injectable drugs and devices (combination products)
• >> Aseptic and Terminal Sterilization Fill & Finish Technologies forPre-Filled Syringes (PFS), ampoules, liquid and lyophilized vials, supporting a wide range of filling volumes
• >> Substantial Drug Product regulatory and filing experience globally (EMEA, FDA, PMDA)
• >> Full-service CDMO offering, project management & integrated supply from APIs to final Drug Products>> Packaging / labeling
• >> Clinical trial drug kit management (logistics, track & trace,documentation)

One Source for Highly Potent & Oncological Products

• Integrated Supply: APIs & Oral / Sterile Drug Products
• State-of-the-art facilities able to handle API and Drug Product of the highest potency
• Development, clinical trial and commercial manufacturing
• Full-service offering including packaging / labeling and distribution n facilities inspected by all major regulatory agencies

Full-Service Partner of Choice from Advanced Intermediates to Drug Products

• Integrated network of cGMP facilities across Europe and US
• 1,200 m3 of volumetric capacity in 20 L - 28,000 L reactors with various materials of construction
• Clinical (Phase I-III) and ongoing commercial supply to multiple markets around the world (including US, Europe and Japan)
• Kilo to Multi-ton production volumes per annum
• Process development capabilities (including flow / continuous manufacturing)
• All sites FDA and EMEA approved facilities with long history of successful regulatory and customer audits
• Strong EHS programs in place at sites

CordenPharma is one of the leading manufacturers of peptide Active Pharmaceutical Ingredients (APIs) with an unprecedented track record of experience in supporting our customer along the value chain ranging from early clinical to commercial in worldwide markets. Today we support more than 50 cGMP development projects targeting either New Chemical Entities or Generic development activities. Furthermore our expertise covers ancillary areas such as conjugation to carbohydrates, lipids and pegylation. Most notably is the fact that scale does not represent any limitation at CordenPharma. We are the only company in the world who has sufficient capacity to produce peptide APIs from gram scale up to annual quantities of hundreds of kilograms. This is underlined by our experience in the manufacturing of Fuzeon® (enfuvirtide), with CordenPharma being the only company to have produced metric tons of this complex peptide.

CordenPharma’s vertically-integrated supply chain model provides development & manufacturing expertise spanning the complete GMP supply chain. Beginning with regulated Key Raw Materials and Non-GMP Intermediates, our sister organization WeylChem supports back integration to secure your supply chain. CordenPharma’s extensive infrastructure then expands the supply chain by providing GMP Starting Materials, manufacturing Active Pharmaceutical Ingredients (APIs) and commercial-scale Drug Products, including finished dosage formulation, and finally by supplying Pharma Packaging & Logistics > resulting in reduced development & manufacturing time and cost.

Sterile Drug Product manufacturing requires dedicated and specialized capabilities which are in compliance with FDA aseptic guidance and EMA regulatory requirements. CordenPharma has a long track record of experience in manufacturing Parenteral Sterile Solutions and Emulsions in different pharmaceutical forms such as ampoules, vials and pre-filled syringes. Our facilities and equipment design, combined with experienced and trained personnel, are pivotal for success in sterile manufacturing. Currently, two sites of the CordenPharma network are involved in Sterile Liquid Drug Product manufacturing – CordenPharma Caponago and CordenPharma Latina.

CordenPharma’s service offerings include a wide range of products, formulations and services supporting new chemical entities, re-formulations and generics:

• Powder & Granule-filled Capsules
• Powder Granules & Pellets
• Immediate Release Tablets
• Controlled Release Tablets
• Mini-tablets
• Multi-layer Tablets
• Blister & Bottle Packaging

LipidsCordenPharma’s scientists have mastered the chemical total synthesis of complex derivatized phospholipids from multi-gram to multi-kilogram scale and are renowned for their contract lipid and phospholipid manufacturing expertise. Our large-scale proprietary cGMP manufacturing processes start with (S)-1,2-isopropylideneglycerol ((S)-IPG) and extend over a cascade of optimised and fully-scalable conversions leading to a wide range of phospholipid molecule derivatives.

Carbohydrates
CordenPharma is uniquely positioned to provide development and manufacturing services along the value chain ranging from clinical activities through process development, scale-up and GMP manufacturing of Complex Carbohydrates for a wide range of applications.

CordenPharma’s expert lipid manufacturers have mastered the chemical total synthesis of complex phospholipid derivatives from multi-gram to multi-kilogram scale and are renowned for their contract lipid and phospholipid molecule manufacturing expertise. Our large-scale proprietary cGMP manufacturing processes start with (S)-1,2-isopropylideneglycerol ((S)-IPG) and extend over a cascade of optimised and fully-scalable conversions leading to a wide range of phospholipids. 

See https://www.cordenpharma.com/apis/lipids-complex-carbohydrates-api-manufacturing/derivatized-phospholipids for more info.

CordenPharma also pioneered the chemistry and large-scale manufacture of MPEG-conjugated phospholipids which can be accessed through a synthesis cascade, rendering them superior quality phospholipid examples for sensitive liposome formulation processes.

• MPEG-2000-DMPE - CAS No 384835-59-0
• MPEG-750-DSPE - CAS No 147867-65-0
• MPEG-2000-DSPE - CAS No 147867-65-0
• MPEG-5000-DSPE - CAS No 147867-65-0
• MPEG-2000-DPPE  - CAS No 205494-72-0

Luxembourg & Magdeburg, 25 May 2021 -- Chemists at CordenPharma and the Otto-von-Guericke-University of Magdeburg, Germany developed a scalable synthesis of pharma-grade cholesterol based on botanical sources.

CordenPharma is your partner of choice in the development and manufacturing of Highly Potent APIs. Our facilities in Boulder, CO (USA) offer API synthesis from early clinical to commercial supply.

Luxembourg, 13 May 2021 -- In Q4 2020 CordenPharma announced both an expansion of non-GMP capacity at our Centre of Excellence for Peptide Process Development in Frankfurt, Germany, and a major increase in upstream capacity with the introduction of a new 3’000 L Solid Phase Peptide Synthesis (SPPS) vessel in CordenPharma Colorado (US).

Let us accompany you on your Sterile Injectable Drug Product journey under CordenPharma's Injectable Technology Platform. Our CordenPharma Caponango (IT) manufacturing facility produces liquid dosage forms with expertise in GMP Manufacturing, Aspetic Fill & Finish, Terminal Sterilization, Clinical Trials, and Pharma-Logistics.

Luxembourg, 19 April 2021 -- In response to the COVID-19 pandemic, mRNA (messenger RNA) vaccines have catapulted to center stage of the pharmaceutical and biotechnology industry. As of early 2021, there are eight ongoing human trials for mRNA vaccines led by Moderna, BioNTech / Pfizer, CureVac, Sanofi / TranslateBio, Arcturus / Duke-NUS Medical School (Singapore), Imperial College London, Chulalongkorn University (Thailand), and Providence Therapeutics.

The Peptides, Lipids & Carbohydrates Platform provides you with advanced Bio-Organic APIs, including synthetic Peptides, Lipids, Carbohydrates & Conjugates, from early-stage to commercial.

If you’re looking for news, product information and market trends from leading pharma companies, the CPhI-Online.com Company Showcases are a great resource for buyers who want to stay up to date, browse product portfolios and find the right partner.

The Highly Potent & Oncology Platform supports your project from clinical through commercial with the development & production of highly potent APIs, Oral Solid Dosage Forms & Injectable Drug Products including ready-for-market packaging, labeling & serialization.

Luxembourg, 7 July 2020 - CordenPharma is proud to announce peptide manufacturing capacity expansion in CordenPharma Colorado, their GMP API facility in Boulder, CO (US). Already known for its unique large-scale peptide offering with a 10’000 L SPPS (Solid-Phase Peptide Synthesis) vessel, and a 100 cm high-pressure reverse phase purification column, CordenPharma Colorado is recognized as the largest worldwide peptide API producer leading the global peptide market.

Our Injectables Platform offers you a broad spectrum of injectable services starting from early-formulation development to full commercial scale, covering both terminal sterilization & aseptic filling. Packaging, labeling & clinical trial kit management round off this service.

Luxembourg, 28 May 2020 -- CordenPharma, a full-service Contract Development & Manufacturing Organization (CDMO) for the supply of APIs, Drug Products & Pharmaceutical Packaging, announces the signing of an amendment to their existing manufacturing agreement with Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients.

Under the Small Molecules Platform we develop and advance your project through all phases to commercial, from advanced intermediates to drug products, from kilogram to multi-ton production volumes annually.

Download this CordenPharma White Paper Below > Get informed about packaging serialization regulatory requirements & deadlines for global markets in this CordenPharma white paper discussing keys to combating the worldwide drug counterfeiting problem. Topics include serialization techniques in the supply chain such as Microscopic RFID Tags, Security Labels, Invisible Inks, and Track-and-Trace Technologies, and a GS1 standard language called Electronic Product Code Information Services (EPCIS). Learn the importance and benefits of choosing the right CMO or CDMO to ensure the utmost level of support in keeping patients safe.

Register for this Live (4-4-18) or on Demand webinar to learn how the most important (and often over-looked) aspect to a robust containment program is the strength of the intangible, softer elements. Discuss how to maximize the success of your engineering control investments and allow for continued alignment to your company’s commitment to providing a workplace free of recognized health & safety hazards.

This recorded webinar archive addresses the necessity of serialization from market compliance to business supply. Expert speaker Mario Scigliano covers all aspects of serialization, from line choice and regulation approach to management of data and related products.

CordenPharma is your Full-Service CDMO partner for the manufacturing of APIs, Drug Products & Packaging. Through an integrated network of cGMP facilities organized under four Technology Platforms - Peptides, Oligonucleotides, Lipids, & Carbohydrates - Highly Potent & Oncology – Injectables - Small Molecules - CordenPharma experts translate complex processes at any stage of development into high-value products. 

AuthorsDr. Oliver Schinzinger, Head of Pharmaceutical Development, CordenPharma Plankstadt
Dr. Eva Fahrländer, Scientific Lead, Formulation Development, CordenPharma Plankstadt
Dr. Christoph Rott, Head of Formulation Development, CordenPharma Plankstadt

Get informed about Pediatric Dosage Form Considerations for Highly Potent Compounds in this CordenPharma whitepaper discussing the benefits of Mini-Tablets as an effective pediatric dosage form. Topics include: Age Appropriate Dosage FormsFlexible & Accurate DosingExcipients & Taste MaskingManufacture & In-Process Control TestingChallenges Transitioning from Tablets to Mini-Tablets 

For generic drug companies, CordenPharma supplies more than 50 Active Pharmaceutical Ingredients (APIs), including controlled substances, for pain management, cardiovascular, gastrointestinal, central nervous system, anti-infective and respiratory indications. We manufacture these products using complex and technical expertise while maintaining a long-standing reputation of quality and reliability.

CordenPharma offers a wide selection of Readily Available Derivatized Phospholipids suitable for Research & Discovery for purchase in convenient 1 g and 10 g pack sizes.

Our Fill & Finish Injectable Drug Product facility CordenPharma Caponago, near Milan, Italy, supports local hospitals with Propofol, an effective medicine that helps support COVID-19 patients.

CordenPharma Colorado works hard for continued business continuity and uses 3D Printer to produce Personal Protective Equipment for local healthcare workers during COVID-19.

Speaker: Dr. Robert Topping, Distinguished Scientist, CordenPharma Colorado

Key Learning Objectives
Learn how large is large-scale peptide manufacturing.What are the factors that change on large-scale manufacturing which could impact product quality & process operations?What are the areas of risk encountered when scaling up?Review safety, health & environmental considerations.

Speakers: Mark Chipperfield (Corvus Ltd), Fabio Stevanon (CordenPharma), Umberto Romeo (CordenPharma)
Key Learning Objectives:
Review the fundamentals of combined injectable delivery device - drug products. Get an update on the latest regulation landscape for combined drug-device products, including some technical challenges for injectable Pre-Filled Syringes (PFS) & Auto-injectors. Gain insight into sound Injectable Drug Product strategy from a Full-Service CDMO industry leader. Learn about recent injectable industry changes facing Pharma, especially in the “New Normal” COVID-19 era, and how CordenPharma’s successful response & expanded capabilities can best support your drug development goals. Learn from an R&D Expert on ways to efficiently develop & commercialize an injectable drug.

Your Injectable Roadmap for Combined Drug Product - Delivery Device Regulations & Evolving Capabilities in the New Normal > How a Full-Service CDMO Supports Pharma

WeylChem InnoTec are your innovative partner to the fine chemical, pharmaceutical and electronic industry. We provide world-class analytical, modern developmental and tailor-made manufacturing services. With our competencies in Analytics, Contract Development & Custom Synthesis, WeylChem InnoTec is your agile development partner.

Our Services:AnalyticsContract DevelopmentCustom SynthesisAdvanced technologies
How We Support You in Different Markets:
Organic ElectronicsCatalysts and LigandsSustainable ChemistryPharmaceutical IntermediatesAgrochemicalsVisit weylchem-innotec.com or email [email protected] for more information.

As your ONE PARTNER, CordenPharma provides you with an integrated solution spanning all product life cycle stages, from preclinical to commercial, supported by dedicated regulatory and project management services.

Since 2021 marks the 15 Year Anniversary of CordenPharma, we take a look back to our founding in 2006 with videos highlighting each of our API & Drug Product facility acquisitions that together, formed the foundation of our integrated supply network across Europe & the US. Thus began the journey of transforming former Large Pharma & Biotech assets into a ONE PARTNER CDMO.

Small Molecule and Lipid Excipient Manufacturing in Liestal, CH

Highly Potent Drug Product Manufacturing in Plankstadt, DE

Peptide R&D Non-GMP Manufacturing in Frankfurt, DE

Peptide, Lipid Excipient and Highly Potent API Manufacturing in Boulder, CO, USA

API and Lipid Excipient Manufacturing in Chenove, FR.

Sterile Injectable Drug Product Manufacturing in Caponago, IT

cGMP API Manufacturing in Brussels, BE

cGMP API Manufacturing in Bergamo, IT