Development and manufacturing of parenteral dosage forms 

Our DPS' offering enables customers to meet some of the greatest challenges in patient treatment. Together with Lonza's existing drug substance development and manufacturing capabilities, our new offering enables us to provide fully integrated service solutions for our customers. 

Our DPS services focus is on parenteral dosage forms, including products for injection and infusion for intravenous, subcutaneous, intraocular and other routes of parenteral administration. Services include options for monoclonal antibodies, other biologics including novel formats, drug conjugates, peptides and small molecules that require a parenteral dosage form.

Our DPS services are offered from laboratories based in Basel (CH), providing pharmaceutical development including formulation and drug product process development, and drug product analytical development and quality control. Specialized services are also available including particulate identification, characterization and quantification, excipient and surfactant characterization, extractables and leachables assessment, testing of container closure integrity, and drug/device combination products. In addition, we offer non-GMP and GMP manufacturing services either at our own manufacturing facilities or at qualified third parties.

Drug product services are integrated across Lonza’s technologies in mammalian, microbial, chemistry, bioconjugates, and cell and viral therapy providing an end to end solution for your biotherapeutic. Take a journey into the virtual reality world of Lonza DPS

The Virtual Reality World of Lonza Drug Product

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Phase appropriate services

Development of parenteral dosage forms can be a major challenge due to the increasing complexity of biopharmaceuticals. We provide fully integrated, phase-appropriate solutions to drug product development and manufacturing addressing formulation, process, and primary packaging across drug substance and drug product services. Solutions that can help to differentiate a product and support lifecycle management.

Meet the expert

Prof. Dr. Hanns-Christian Mahler, Head Drug Product Services

Hanns-Christian Mahler has extensive experience in drug product development and manufacturing. For more than 15 years, he worked for Merck and Roche in leadership roles, most recently as Head of Pharmaceutical Development & Supplies Biologics EU (Roche). Hanns-Christian participated in several product IND/IMPD submissions and numerous market launches for high profile products. He has broad industry experience in parenteral formulation and process development, line extensions, primary packaging development, device development, drug product clinical and commercial manufacturing and transfers.

Hanns-Christian studied Pharmacy and holds a Ph.D. from the Institute of Pharmacy at the University of Mainz (DE). In addition, he has Specialist Pharmacist degrees in Pharmaceutical Technology and Toxicology & Ecology from the German Pharmacists Chamber (DE). He made his Habilitation in Pharmaceutical Technologies and is extraordinary Professor for Pharmaceutical Technology at the University of Frankfurt (DE) and adjunct faculty member and lecturer at the University of Basel (CH). He also serves as an expert on EDQM (Ph.Eur) committees and other industry consortia. Having published more than 60 scientific manuscripts and submitted more than 20 patent filings, Hanns-Christian was elected an AAPS fellow in recognition of his scientific achievements in 2013. The Parenteral Drug Association (PDA) awarded him the Distinguished Service Appreciation Award in 2018. This award is given in recognition of special acts, contributions or services that have promoted the success and strength of PDA.

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Second generation container closure integrity testing

Our DPS team has developed proprietary, IP-protected container-closure integrity (CCI) testing. That proprietary system can evaluate CCI using highest sensitive helium leakage pCCI testing for vials, syringes and cartridges and can evaluate specific requirements, such as the impact of stopper height on CCI, as per recent Annex 1 GMP requirements.

Center of excellence

Our DPS activities are performed in Basel, Switzerland. Drug product development services are based in a 3000 m2 facility in the Stücki Technology Park Basel. Additional space of 8000 m2 will be added mid 2020. The DPS unit is comprised of a number of development labs, with state-of-the art analytical, formulation and drug product processing equipment.

Basel, Switzerland

Headquarters, Sales & Support, Research & Development

Muenchensteinerstrasse 38
Basel 4002