The Partner You Need for Sterile Injectable Drug Products
Expertise in sterile injectable development and manufacturing is fundamental in bringing effective parenteral medications to patients. CordenPharma has over 25 years of experience producing sterile injectable drug products, with quality and compliance central to all of our activities and projects. We offer substantial global regulatory and filing experience, delivering to over 110 different markets. Our cGMP sterile manufacturing site is fully inspected by global regulatory agencies including, but not limited to, EMA (AIFA), FDA, ANVISA, TGA.
We offer you access to broad manufacturing capabilities starting from early formulation development, and clinical manufacture through to full commercial scale, covering both aseptic fill and finish, as well as terminal sterilization technologies for Pre-Filled Syringes (PFS), vials (liquid and Lyo), ampoules, and cartridges in a wide range of filling volumes. With various processes and filling lines and an overall annual capacity of ~100 million units, our injectable platform offers the flexibility to support you with multiple programs in parallel, at any scale and stage of drug development or commercialization.
Our core injectable capabilities include:
- Contract development & manufacturing expertise for sterile liquids & lyophilized solids
- Lipid NanoParticle (LNP) formulation development & GMP manufacturing
- Full range of services including formulation development, analytical development, clinical & commercial manufacturing
- Wide range of injectable drug product formats (ampoules, vials, pre-filled syringes (PFS) & cartridges)
- Capability & compliance to sustain aseptic fill & finish or terminally sterilized injectables
- Aseptic fill & finish of complex modalities (e.g. peptides, LNPs, oligonucleotides & biologics)
LNP Formulation & Manufacturing
- Our sterile injectable facility provides the benefit of housing LNP formulation and cGMP manufacturing in the same facility as our aseptic fill and finish lines.
- We provide LNP development and cGMP manufacturing, incorporating different scalable technologies, such as microfluidics and jet impingement, as well as Tangential Flow Filtration (TFF) equipment for diafiltration and concentration of LNP formulations to manufacture targeted nanoparticle-formulated drugs encapsulating your biological payload (e.g. mRNA, RNA, Oligos).
- Additionally, all chemical, microbiological and LNP analyses are performed on site, and the same facility and equipment can be used for polymer, peptidic and other types of nanoparticles.
Integrated Supply for LNP Manufacturing
Our supply model provides you with integrated fill and finish and LNP drug product services with easy and streamlined access to custom peptide and oligonucleotide APIs, as well as custom and standard lipid excipients (e.g. glycero-phospholipids, sphingolipids, phosphocholine, pegylated, and cationic lipids).
This simplified end-to-end service reduces your risk and cost associated with technology transfers, and ultimately provides faster production and delivery timelines.
Your Benefits > Our Strengths
1) Versatile Support Throughout Your Injectable Drug Product Lifecycle > Wide & Balanced Range of Injectable Services
Benefit from our integrated injectable services from early formulation development and clinical testing through filing and commercial supply.
2) Focus on Reliable Safety Expertise > Quality is the Foundation of Every Step Your Project Takes
Rely on the integrity of our robust quality, regulatory compliance, and manufacturing standards from initial process development through product delivery, supported by substantial global regulatory and filing experience (EMA, FDA, PMDA).
3) Lipid NanoParticle (LNP) Technology > Fully integrated Offering for Lipid Supply, LNP Formulation, Aseptic Fill & Finish
Get access to our state-of-the-art R&D LNP lab for formulation screening, and select the appropriate lipids from our broad lipids portfolio. Benefit from scale-up into GMP manufacturing directly at the fill and finish facility.
Downloads
Seamless Integration Across the Supply Chain
Working and coordinating with several providers can be demanding and time-consuming when outsourcing a project. We aim to streamline your process, improve efficiency and reduce costs by consolidating multiple services in one organization. As your CDMO partner, we work alongside you to understand and anticipate your project needs.
We deliver them through seamlessly integrated technologies and services from across our expert global network that support the development and manufacture of pharmaceutical and biotech innovators’ complex modalities. Our bespoke end-to-end solutions span your supply chain, covering all stages from drug development to commercialization.
