Drug Development and Manufacturing from PCI

At PCI, we are dedicated to ensuring the success of your product from the very early stages of development, through the clinical lifecycle to commercialization and beyond. With over 35 years of experience in the processing of highly potent molecules and over 25 years of experience in lyophilization and sterile fill-finish, we combine our heritage with state-of-the-art technologies and our highly skilled workforce to deliver a seamless end-to-end solution for each and every drug product. A global network of clinical and commercial scale packaging centers of excellence support our development and manufacturing services. These include specialist high potent and biologic packaging capabilities, delivering both clinical supplies and commercial products to patients globally. Sterile Fill-Finish & Lyophilization 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. High Potent Services 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. High Potent Oral Dose 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. High Potent Sterile Fill-Finish and ADCs Antibody-drug conjugates (ADCs) are transforming oncology treatment and at PCI, we believe that selecting the right CDMO for your new ADC is as important as selecting the right ADC components. As a partner, we offer stability, quality, strategic alignment and a forward-thinking approach in the development and manufacturing of your ADC product, supported by full, temperature-controlled packaging, storage and distribution services from our clinical packaging sites globally. The components required for the successful development of ADCs include Sterile fill-finish, lyophilization and specialist high-potency processing capabilities. At PCI, our Integrated ADC Development Services include: Development, optimization and manufacturing services Process development, process optimization and scale up Formulation development (liquid and lyophilized) and drug product development Regulatory support In addition, our experienced analytical teams will ensure a successful development program. As a global leader of sterile fill-finish, lyophilization and high potent manufacturing services, a dedicated team will support your product lifecycle with method development, method optimization, method transfer and method qualification/validation. To complete our end-to-end service offering and driven by innovation and patient-centricity, our packaging design and development expertise, drug device final assembly, pack and test, and advanced drug delivery packaging capabilities offer flexible solutions for a diverse portfolio of conventional and specialty injectable drug products.