Our Drug Product Services team is highly skilled in the development of biopharmaceuticals including standard monoclonal antibodies, recombinant proteins, fusion proteins and antibody-drug-conjugates.
Pharmaceutical development services are available for liquid and lyophilized drug product dosage forms and are integrating development of the drug product formulation, drug substance composition, container closure systems such as vials, stoppers and caps or syringes, drug product process manufacturing process and adequate target product profile to ensure quality, compliance, usability and competitiveness of the drug product being developed.
The service offerings comprise the complete array of development activities for parenteral Drug Products, ranging from:
- early-stage formulations
- late-stage formulations for commercialization
- post-launch formulation optimization
- container closure system selection and qualification
- design and testing of simulated administration to preclinical study subjects and healthy volunteers and patients in clinical studies
- manufacturing process setup and design, selection of unit operations and process ranges, selection of processing materials such as disposable tubing and filters and process development and characterization
- tech transfers
- manufacturing of supplies for preclinical (GLP) and clinical studies (GMP manufacture)
Our highly skilled team is experienced in designing an appropriate and cost-efficient development strategy, enabling fast development timelines with appropriate quality and mitigation strategies. Our experts can support most challenging projects and target profiles, including intravitreal and subcutaneous products and understand requirements and typical requests from health authorities globally in depth. We support Quality-by-Design (QbD), accelerated and Breakthrough Therapy submissions.
Our Drug Product Services team works closely with our Drug Substance sites across the Lonza network enabling an integrated and high quality One-Stop-Shop from a single service provider.
We aim to provide fit-for-purpose solutions tailored to your drug program - all services are available as integrated packages or as standalone.