Drug Product Development and Manufacturing
Selecting the right cGMP contract manufacturer to produce your final manufactured and packaged drug product is an important decision. As your CDMO partner, we provide development and manufacturing services for oral solid dose (OSD), non-sterile liquid and rectal dosage forms, and parenteral dosage forms for all phases of clinical development through commercialization.
This broad spectrum of capabilities also allows formulations of highly potent and oncological compounds. All of our state-of-the-art facilities are equipped with automated primary and secondary packaging lines with full labeling and serialization capabilities.
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Non-Sterile Dosage Forms
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Sterile Dosage Forms
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Drug Product Support Services
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Pharma Packaging Services
Non-Sterile Dosage Forms
How We DeliverWe offer drug product development and manufacturing services for oral solid dose (OSD) and other non-sterile specialty dosage forms for all phases from clinical development through commercialization.
Oral Solid Dose
Our three facilities focused on the development and manufacture of oral solid dosage forms have capabilities in conventional processing technologies (wet and dry granulation, fluid bed) for tablets (standard, minitablets) and capsules (direct API, powders, pellets, minitablets), including aesthetic and enteric coating.
Non-Sterile Liquids
We have multiple sites that develop and manufacture non-sterile liquid dosage forms including suspensions, drops, and nasal sprays. We have various compounding (mixing, homogenizing) equipment and automated bottle filling lines for all of these dosage forms.
Rectal Dosage Forms
We have extensive expertise in developing and manufacturing rectal dosage forms (suppositories, enemas). Core capabilities include compounding (mixing, homogenizing) for liquid and semi-solid drug products, as well as automated filling lines.
Sterile Dosage Forms
How We DeliverWe offer drug product development and manufacturing services for sterile dosage forms for all phases from clinical development through commercialization. We offer solutions, suspensions, emulsions, lyophilized powders, and lipid nanoparticle (LNP) formulations, using both aseptic and terminal sterilization technologies. We have multiple packaging solutions including vials, ampoules, cartridges, and pre-filled syringes (PFS).
Sterile Liquids
We have extensive expertise in developing and manufacturing injectable liquids including specific techniques such as sterile emulsion technology and LNP formulations. Various forms of packaging are available.
Sterile Powder-Lyophilized Vials
We also offer development and manufacturing of sterile powder-filled vials and lyophilized vials for various types of active ingredients (e.g. small molecules, peptides, proteins, monoclonal antibodies, oligonucleotides).
Drug Product Support Services
How We DeliverOur drug product support services include bioavailability enhancement capabilities for solubility-challenged APIs and lipid nanoparticle (LNP) formulation development.
Bioavailability Enhancement
As a part of our Early Phase Drug Product Innovation Centre of Excellence, bioavailability enhancement capabilities are available for addressing formulations containing solubility-challenged APIs. We have enabling technologies such as spray drying, hot melt extrusion, nanomilling, and micronization to address absorption issues, as well as access to a portfolio of lipid excipients for SEDDS / SMEDDS formulations that can address permeability issues.
LNP Formulation Development & Manufacturing
We offer LNP formulation development, incorporating different technologies (from microfluidics to jet impingement) as well as proper diafiltration / concentration to allow you to manufacture targeted nanoparticle formulated drugs encapsulating your biological payload (e.g. mRNA, RNA, oligonucleotides).
Pharma Packaging Services
How We DeliverCordenPharma is an internationally approved expert in contract manufacturing and packaging of many different dosage forms. Various primary and secondary packaging technologies are available across our network of facilities throughout Europe and the US including bottles, blisters, and sachets.
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 legislation 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 touch-points 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.
Want to find out more?
Get in touch with our team of experts to explore bespoke end-to-end CDMO support of your complete drug lifecycle
at any scale.