ABOUT CORDENPHARMA INTERNATIONAL
Full-Service CDMO for a Global Market
CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Drug Products and associated Packaging Services. Through a network of cGMP facilities across Europe and the US organized under four technology platforms – Peptides, Lipids & Carbohydrates – Injectables - Highly Potent & Oncology - Small Molecules - CordenPharma experts translate complex ideas, processes and projects at any stage of development into high-value products.
ONE PARTNER Supply Solutions
CordenPharma’s ONE PARTNER Supply Solution spans your complete product life cycle at all stages - from manufacturing of back-integrated non-GMP Intermediates to secure your supply chain, through preclinical & commercial development and manufacturing of GMP starting materials, APIs, finished dosage Drug Products & Packaging - resulting in reduced time & cost. Your project is all the while supported by dedicated regulatory & project management expertise at every step along your outsourcing path.
Your ONE PARTNER Benefits:
- Single point of contact throughout your project for both APIs & Drug Products
- Global SOPs mean shorter tech transfer time for materials & documentation
- Knowledge transfer guaranteed with consolidation of stability testing, analytical methods & physical property
- One CDA / MSA with single data-entry point ensures ease of sharing data internally & externally and speed of execution
- Improved data integrity guaranteed by controlled single-source data with integrated project planning
Battling Counterfeit Medicine Through Packaging Serialization
Medicines need to be packaged in a way that allows counterfeits to be quickly and easily identified, preventing their circulation and/or eliminating drug recalls. An essential element of this process is package serialization. Outsourcing work with contract manufacturers is one such way to be fully prepared for serialization implementation across all production lines.
Pediatric Dosage Form Considerations For Highly Potent Compounds
The development of pediatric medicine poses numerous challenges to pharmaceutical formulators, particularly products intended for infants and very young children. This white paper describes special considerations for selecting appropriate pediatric dosage forms and the benefits of choosing mini-tablets (e.g., orodispensible) for pediatric formulation, particularly for highly potent compounds.
Scale-Up Considerations For Large-Scale Peptide Manufacturing
The chemical and operational challenges and risks of peptide synthesis are magnified when considering the transition from lab-scale preparation to large-scale plant manufacturing. This webinar will identify aspects of scale-up peptide manufacturing that the CordenPharma Colorado manufacturing site has focused on for large-scale development and implementation of commercial peptide APIs. These aspects, along with their associated benefits & challenges, will be presented as topics that an organization needs to consider, identify and manage in order to prepare & develop successful manufacturing strategies and process controls.
Critical Aspects Of A Robust Highly Potent Compound Program
When handling highly potent compounds, protecting workers from exposure is both critical, but also extremely challenging. Unfortunately, installing containment devices is only one step to full containment. This webinar will address five aspects of a robust highly potent compound containment program organized in what CordenPharma refers to as The Containment Puzzle.
Navigating Injectable Combination Device & Drug Product Regulations
Many new pharma development projects and lifecycle management opportunities are exploring the integration of medical devices with drug products as the industry seeks more convenient, user-focused drug delivery solutions. This webinar will introduce the topic of combination device & drug products, provide an overview of the regulatory landscape with a particular focus on injectable drugs.