Your world leading CDMO. Drug Development & Manufacturing.

Our global manufacturing capabilities in complex formulations, high potency, and lyophilization cover a broad range of injectables including nanoparticles, mRNA, MABs, proteins, oligonucleotides, and other biologics across multiple delivery formats from vials and bottles to prefilled syringes and autoinjectors.

Our biotech packaging centers of excellent complement our development and manufacturing services to provide a comprehensive service through the product lifecycle.

We have the capability to deliver at any stage of your sterile fill-finish project with true expertise and to tight timelines, managing solubility and stability challenges as well as assisting with challenging formulation processes.

Our Sterile Formulation Development Services

Based on the results of an in-depth Process Risk Assessment of your current manufacturing process, we will work with you to determine the Critical Process Parameters (CPPs). We will design an experimental plan to investigate and characterize the CPPs. Using the Quality by Design (QbD) approach, we can develop a formulation that will increase product solubility. If an aqueous formulation does not yield the desired concentration, we can use complexing agents such as cyclodextrins or an organic solvent formulation, emulsion, or suspension.

We provide complete pharmaceutical development and manufacturing services for both investigational and commercial products including highly potent molecules requiring specialist handling. Complemented by specialist high potent packaging suites, we are able to take the most potent of products from development to launch.

Our comprehensive pharmaceutical development service offering includes new drug development, early stage formulation, and analytical development for both highly potent and non-potent drug products.

Our strength lies in the integrated nature of our services, combining formulation and analytical development with GMP clinical manufacturing and packaging through a full cross functional project team, coordinated by an experienced team of project managers.

Utilizing our state-of-the-art facilities, we offer unrivaled capabilities and a true focus on customer needs. We provide clinical manufacturing of multiple dosage forms for investigational use including solid oral dose, liquids, and semi-solids.

We are able to offer API directly into capsules and vials using microdosing technology as well as the more traditional development pathways. The microdosing drug in capsule (DIC) and drug in vial (DIV) approach offers time and cost efficiencies as well as the potential to reduce wastage of often expensive APIs.

Following early stage development, we continue with further development, scale-up, and process validation ahead of commercial launch for a variety of dosage forms, all supported by full in-house analytical development and release services.

All clinical manufacturing services are fully supported by a dedicated and experienced team of Qualified Persons, a full analytical laboratory, and a GMP-compliant warehouse.