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ONE PARTNER CDMO Helps Navigate Supply Chain

Edition 3 / October 2021
Integrated Supply Article > Navigating Pharmaceutical Supply Chain: The Right Partner is ONE PARTNER

Edition 3 / October 2021

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Clemence Buisan, Senior Manager, Sales & Key Account Management Cordenpharma, headshot

Author
Clemence Buisan,

Associate Director, Sales & Key Account Management
CordenPharma International


Navigating Pharmaceutical Supply Chain: The Right Partner is ONE PARTNER

Graphic showing API, sterile injectable, oral solid dosage and packaging fully integrated CDMO manufacturing services

CordenPharma’s Fully Integrated Supply Offering spans from the manufacturing of APIs and Excipients to Sterile Injectables, Oral Solid Dosage Drug Products and Packaging.

Visit Us In-Person at CPhI Worldwide 2021
To Discuss Our Fully-Integrated Services
Nov 9-11 | Milan, Italy

Increasing Drug Development Complexity

The combination of drug complexity with a high number of stakeholders on one end, and the rise in regulatory pressure on the other, has made the supply chain a difficult task to manage. Pharma companies and regulatory agencies are investigating the whole process with greater scrutiny by requesting more details at every step in the supply chain to secure product quality. CDMOs in turn have to constantly evaluate, adjust, invest and reinvent themselves to address these requirements based on the market challenges. Is your CDMO up to the task?

Working and coordinating with several providers can be demanding and time consuming when outsourcing a project – especially during the pandemic period over the last 18 months. Constantly increasing drug development costs are pushing the pharmaceutical sector to challenge its growth strategy and adjust to address risk. Furthermore, newly developed drugs have reached a high level of complexity, which then adds more challenges to the supply chain management. Examples of sophisticated drugs include the use of novel drug delivery systems like Lipid NanoParticles for mRNA vaccine development, conjugations, and complex formulations requiring special excipients. Drug development is an inherently complex endeavor, involving numerous scientific disciplines and a high degree of scientific uncertainty.

World map graphic showing global connections of the pharmaceutical supply chain’s integrated services.

Integrated Supply services help our customers navigate the Pharmaceutical Supply Chain

CMC Controls Are a Key Driver for Your Successful Launch

Chemistry Manufacturing and Control (CMC) is a critical element of the drug development process, involving the manufacture of bulk Active Pharmaceutical Ingredients (APIs) and their final Drug Products (DP) for use in the clinic, along with a myriad of supporting activities. CMC management is a demanding and complex undertaking, which is frequently underestimated. It requires a high level of scientific & technical expertise, a full understanding of the relationships and interdependencies between synthesis, formulation & quality control, coupled with established interpersonal skills to facilitate close coordination of the diverse range of activities required to deliver a successful project.

CordenPharma’s integrated supply offering provides APIs that can then formulated into Oral Solid Dosage Tablets or Injectable Drug Products.

CordenPharma’s integrated supply offering provides APIs that can then formulated into
Oral Solid Dosage Tablets or Injectable Drug Products.

CordenPharma’s Fully-Integrated Services

Although end-to-end visibility should be the key driver of the supply chain, it is often currently missing, or rather fragmented and unclear. Clarity doesn’t necessarily relate to which stakeholder is producing which product in the chain, but more importantly tied to management of the quality and regulatory aspects associated with various manufacturing process changes and their impact on the final product. This landscape thus demands very close collaboration and transparency between all stakeholders involved.

CordenPharma has the privilege of being one of the few CDMOs in the industry with both end-to-end Fully-Integrated Supply services and backward integration of critical starting materials, available through our sister company Weylchem. This has proven to greatly benefit our customers with reduced complexity in their supply chain and faster speeds to market for their pipeline.

With several multi – site projects per year, we strongly believe Integrated Supply is the most effective solution for all types of customers, from virtual biotechs to big pharma. Our Fully-Integrated Supply solution guides you in every step along your outsourcing path from the manufacturing of back-integrated non-GMP starting materials to secure your supply chain, through pre-clinical & commercial development and manufacturing of GMP intermediates, APIs, Excipients, finished dosage Drug Products & Packaging.

CordenPharma’s integrated supply graphic for peptides to injectables, lipids to LNP formulation, HPAPIs to oral solid dose.

From starting materials through APIs, Excipients, Drug Product and ultimately Secondary packaging, CordenPharma is your ONE PARTNER CDMO, providing you with fully-integrated services spanning the complete product life cycle, from pre-clinical to commercial.

Our Integrated Supply Offering

  • >> Raw Materials and Regulatory Starting Materials from our sister company Weylchem
  • >> Small Molecules APIs to Oral Solid Dosage Drug Products, for efficient and reliable clinical & commercial supply
  • >> Peptide APIs to Sterile Injectable Drug Products, with peptide development & commercial manufacturing capacity, and sterile Fill & Finish vial & Pre-Filled Syringe cartridges
  • >> Lipid Excipients to Lipid NanoParticle (LNP) Formulation for Injectable Drug Products, with greater manufacturing capacity for both, ideal for vaccine development
  • >> Highly Potent APIs to Oral Solid Dosage Drug Products, with development & commercial capacity for tablets and coated tablets
  • >> Secondary Packaging
  • >> Logistic Supply to Clinical Center

Your Integrated Supply Benefit

  • >> Shorter Time-to-Market with overall shorter development & manufacturing timelines
  • >> De-risking the Supply Chain
  • >> Harmonized Quality System & Project Management Organization
  • >> Reduced customer project management resources required with only one vendor
  • >> Cost savings (audit, QC release, project management)
  • >> One dedicated Project Manager to help navigate your way to project completion with straightforward communication
  • >> Ease of logistics in shipping materials within CordenPharma’s facility network

Through our network of eight integrated cGMP facilities across Europe and the US organized under five Technology Platforms – Peptides, Lipids & Carbohydrates, Highly Potent & Oncology, Injectables, Small Molecules – we have fostered an efficient exchange between API & Drug Product teams to decrease your development time to market.

In this multi-faceted environment, dealing with a ONE PARNTER CDMO reduces complexity and efficiently supports the direct impact you have on patients. CordenPharma’s team strives for excellence every day to deliver on-time, high quality products with integrity, transparency and flexibility.


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