Biologics Special Services

Wide Range of Special Drug Product Services

Lonza DPS offers a wide range of special services for biologics molecule drug products.

Industry-leading Forensic Chemistry Labs

We have experience in designing, performing and reporting extractables and leachables studies for container closure systems as well as process and manufacturing equipment

Fast-track Particle Contamination Root Cause Investigations

Together with our particle lab, our forensic chemistry group offers fast-track particle contamination root cause investigations in drug product processing

Our forensic chemistry group can help you with designing, performing and reporting extractables and leachables studies for container closure systems as well as process and manufacturing equipment.

Visible, subvisible and submicron particle characterization

Our particle testing lab can help design an adequate subvisible and submicron particle-control strategy including specification setting to meet current health authority requirements and beyond.

Our forensic chemistry particle testing lab offers fast-track particle contamination root cause investigations in drug product processing and manufacturing and provides best inputs into regulatory filings and questions.

Packaging and device characterization (surface morphology, computer tomography)

We perform glass delamination assessments, fogging studies and characterization by Scanning Electron Microscopy and computer tomography to generate valuable insights, such as potential stability liabilities, and potential container issues that may occur during processing and manufacturing.

Drug and device combination product functionality testing

Our team has in-depth experience with drug and device functionality testing (such as injectability) as well as access to the required equipment to thoroughly characterize and optimize the necessary parameters, to ensure successful functionality throughout the shelf-life.

Ensure patient safety and success for your parenteral drug program

Preclinical administration set and testing
The preclinical compatibility testing ensures the use of compatible administration sets to eliminate any risks to the GLP preclinical safety/toxicity studies due to incorrectly dosed and/or unstable drug product or incompatible devices.

Clinical administration setup and testing
Demonstrating in-use stability and administration device compatibility is essential to ensure patient safety and the success of the clinical study. We will help you choose the right setup, execute a time-critical compatibility study and ensure acceptance by global health authorities.

Microbiological in-use time definition and testing
We will support you with risk assessments and evaluations to define microbiological in-use times for use in clinical studies and commercial use.

Pharmacy manual and trainings
We can help you to develop protocols on how a specific product should be handled and used (we can also provide training and materials to clinical centres)

Our locations

Location where this service is provided

Basel, Stücki Technology Park, Switzerland

The Drug Product Services (DPS) group is located in Basel, Switzerland with state-of-the-art analytical, formulation and drug product processing equipment, and unparalleled expertise in parenteral drug product development, manufacturing and testing.

The DPS team is highly experienced in the development, manufacture and analysis of parenteral formulations and finished drug products for injection, infusion or implant of a variety of product types and molecules. The drug product analytical development and quality control group has industry-leading technical, scientific and regulatory expertise in method development, product characterization and testing of biopharmaceuticals and parenteral small molecule formulations.

Regulatory expertise

Pathway to success in Regulatory filings

Extensive Regulatory Expertise

We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.

Dedicated Regulatory Affairs Contact

We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.

Keep Pace with Regulatory Thinking

Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.

Biologics

Related Insights

Visit Knowledge Center