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Drug product manufacturing encompasses a number of activities including selection and qualification of the right primary packaging, manufacturing of non-GMP drug product batches for toxicological and stability studies as well as GMP batches for clinical and commercial supply of different biologic modalities. Additionally, our experienced team can execute technology transfers with a focus on details to ensure success, as well as doing time-critical root-cause investigations as part of deviation management.

There is a lot more to drug product manufacture than filling vials, syringes and devices. Our extensive drug product capabilities include selection and qualification of the right primary packaging.

 

  • Development, Tox batch and Reference Standard manufacturing

    Regulators require that the batch used for toxicological studies is comparable to and representative of the Phase 1 clinical material. This is to ensure patient safety, and to assess any difference in the manufacturing process between the two lots. Accordingly, using a technical DP batch of adequate quality that is manufactured representatively for the tox study increases the likelihood of having comparable material and the success of the development program. Additionally, performing stability testing on the non-GMP tox batch will provide stability data that supports shelf life setting of clinical GMP material. This approach can accelerate the timeline for IND submission.

    Our state-of-the-art pilot-scale aseptic manufacturing capabilities allow the supply of liquid and lyophilized drug product batches that is representative of clinical drug product which we will provide. Our tox supply is of adequate quality and includes compounding up to 20 L of bulk drug substance and automatic filling of vial sizes ranging from 2R to 20R vials, as well as syringes or cartridges. This material is suitable for Reference Standards.

    We can also supply high-potent drug products such as Antibody-Drug Conjugates (ADCs) for toxicological study and/or stability and regulatory purposes. We have the ability to freeze-dry under the most-adequate EHS protection approaches.

  • Our DPS team offers clinical and commercial DP GMP manufacturing of biologics (microbial or mammalian proteins), as well as peptides and oligonucleotides both as liquid and lyophilized products. This is either within our own manufacturing facilities or at approved and qualified third parties.

    Our experienced DPS team will perform thorough risk assessment that will be discussed with customers, execute engineering batches as required, create PPQ protocols and batches,  generate submission relevant reports and prepare the regulatory submission.

    Our state-of-the-art DP fill & finish facility has a proven track record of 10 years' successful operations. Together with our development and drug substance offerings, we support a fully integrated offering from gene to product, which simplifies project planning and execution.

  • Deviations are not uncommon during manufacturing, and root-cause investigations (RCIs) are necessary to identify the underlying causes. This is followed by putting the appropriate corrective and preventive actions in place. Many times, such RCIs are time-critical and require broad expertise and sound scientific knowledge to rapidly identify the underlying causes. Our Drug Product Services team can support a large variety of challenges that may be encountered during development and/or drug product manufacture. Our experts can support assessments as well as RCIs, and generate required data to close out the investigation.

  • Primary packaging is in direct contact with the formulated biologic throughout its shelf-life, and can thus have significant impact on its stability and performance. The selection of the appropriate primary packaging (e.g. type of glass, its lamination material, lamination and dimensions of the stopper) are important selection parameters. The preparation process of the primary packaging for aseptic manufacturing (e.g. sterilization and depyrogenation process) also has an impacts on the properties of the primary packaging and its compatibility with the active ingredient. With prefilled syringes, the type of siliconization, amount and distribution of silicon oil impact product stability as well as functionality. Finally, container closure integrity (CCI) is affected by the crimping parameters, and needs to be carefully qualified.

    Our DPS experts will support the selection and qualification of the right primary packaging that is compatible with the drug product formulation.

  • A thorough understanding of the product liabilities as well as the details of the manufacturing process and capabilities, together with the regulatory requirements are required for a successful tech transfer. Due to our DPS team’s long experience and solid technical expertise in aseptic drug product manufacturing, they will design the suitable clinical/commercial manufacturing process for your molecule, generate the required source documents for manufacturing and, if required, accompany the manufacturing on-site for rapid technical support. 

Meet the expert

Dr. Franziska Riesen, Head Drug Product Manufacturing

Franziska Riesen brings to Lonza more than 14 years of experience in sterile and aseptic drug product manufacturing and Quality Assurance. Before her current role at Lonza, Franziska worked at Roche in various functions, with responsibilities that included managing the manufacturing of liquid products in vials and pre-filled syringes, and leading cross-functional contract manufacturing teams. She also represented the company during inspections and audits, including U.S. Food and Drug Administration (FDA), Japan, and Swiss Authorities.

Prior to her experience in manufacturing, she was responsible for Quality Assurance activities for drug product manufacture and Quality Control, including release, stability, transfers, discrepancy management, corrective and preventive actions (CAPA), change control, and complaint management.


Technologies and products


Unlike other contract development and manufacturing organizations (CDMOs), Lonza is in the unique position to offer complete development and manufacturing services from both mammalian cell culture and advanced chemical synthesis for the production of Antibody-Drug Conjugates (ADCs). From process development to manufacturing scale-up, we are proud to offer more ways than ever to deliver your product.

technology
Chemical Synthesis Technologies
Lonza provides integrated chemical synthesis services for small molecules, from initial route scouting through to commercial-scale process intensification.