Center of excellence for soft gelatin capsule development and manufacturing


At our facility in Ploërmel (France), we serve the global market with integrated product design, development and manufacturing of specialty soft gelatin and liquid-filled hard capsule (LFHC) drug products.

Lipid-based formulations utilizing soft gelatin capsule or liquid-filled hard capsule technology is a key platform in our bioavailability enhancement suite of technologies. Soft gelatin capsule technology also has proven application as safe and effective dosage form for HPAPI / low-dose applications or hormones, as well as for providing a suitable barrier for light and/or oxygen sensitivity.

The technology is highly flexible and used for new product development as well as life cycle management:

  • Encapsulation of a wide variety of fill formulations
  • Wide array of sizes, shapes, colors and forms
  • Oral, topical, ophthalmic and vaginal delivery

Our Center of Excellence for soft gelatin technology serves a global market, and we have an extensive track record in designing effective lipid/ semi-solid/ liquid formulations, and advancing compounds from feasibility through clinic to commercialization.

Services


Our Ploërmel site provides fully integrated services to take your compound from concept to commercialization. Multiple phase-appropriate production lines are utilized for non-GMP studies and cGMP clinical and commercial-scale manufacturing services.


Powder-in-capsule services for accelerated development


Ploërmel also serves as the European service center for our rapid first-in-human (FIH) studies utilizing Powder-in-Capsule (PIC) and Powder-in-Bottle (PIB) approaches based on our proprietary Xcelodose® Precision Powder Micro-Dosing Technology. These studies are proven to reduce development time to FIH by more than 13 weeks. We have industry-leading capabilities, expertise and capacity for Xcelodose® based studies having produced more than 700 batches with more than 200 compounds across a myriad of drug substance parameters. Ploërmel is equipped with multiple Xcelodose® units for feasibility studies and cGMP clinical manufacture of PIC or PIB-based formulations.

Lonza has more than 20 years' experience in developing and manufacturing specialized drug products based on lipid / liquid-based formulation technologies.

View our webinar

Lipid-Based Formulations for Early Stage Clinical Trials

Soft gelatin capsule development and manufacturing services


At Ploërmel, we offer end-to-end product design, development and manufacturing services for your formulation challenges utilizing lipid/liquid based formulations in either soft gel or LFHC product formats. In addition to standard compounds, we are equipped to support highly potent compounds or hormones throughout the development process to commercialization of these specialized drug products.  Multiple soft gelatin capsule production lines ensure manufacturing and supply flexibility.

Our Ploërmel team is equipped for the full range of pre-formulation and feasibility studies, including liquid-based solubility screening of new chemical entities and in vitro evaluation of lipid-based formulations to predict in vivo behavior. Full analytical services are in place for method development and validation. Dedicated development suites are used for a small-scale lab encapsulation for feasibility assessments, stability data generation and final formulation selection.

The Ploërmel site provides additional formulation technologies and approaches beyond its core softgel capabilities. Lipid / solvent / co-solvent based product development and manufacture of liquid fill hard capsules (LFHC) is also supported with multiple development and production lines.  The choice between the technologies is typically dependent upon application, API characteristics and formulation parameters.

The site can also produce proprietary lipid multiparticulate (LMP) formulations which are finding increased application as a highly flexible approach for taste-masking, controlled release and solubility improvement.

Lonza Ploërmel supplies drug products based on soft gel and liquid-filled hard capsule technology to a global market, and has been inspected by the FDA, ANVISA, ANSM, MEB and AEMPS.

Our team works as an integral component of our development network in the US and Europe, which serves to share best practices and to ensure that the right formulation approach is taken to meet your target product profile and commercial objectives.

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