Parenteral 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.

We have established expertise and a strong track record in progressing small molecule parenteral products from design, through development and clinical studies, to commercial scale manufacturing. 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.

  • Primary Packaging Development and Qualification

    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 impact on the properties of the primary packaging and its compatibility with the active ingredient. In the case of prefilled syringes, type of siliconization, amount and distribution of silicon oil impact product stability as well as functionality. Finally, container closure integrity 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.

  • Regulatory Authorities require that the batch used for GLP tox studies is comparable to the phase 1 clinical material to ensure patient safety, and any difference in the manufacturing process between the 2 lots should be specified. Accordingly, using a DP batch of adequate quality for the tox study increases the likelihood of having comparable material and the success of the development program. Additionally, performing the DP stability testing on the tox DP batch will provide supportive stability data that can accelerate the timeline for IND submission.

    Lonza DPS’ pilot-scale aseptic manufacturing capabilities allows the supply of liquid and lyophilized development drug product batches, including compounding up to 20 L of bulk drug substance and automatic filling of vial sizes ranging from 2R to 20R vials.
  • A thorough understanding of the product characteristics 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 the Lonza 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.
  • Lonza DPS offers clinical and commercial drug product GMP manufacturing of small molecules both as liquid and lyophilized products. This is either within Lonza’s own manufacturing facilities or at approved and qualified third parties.

    Lonza’s experienced DPS team will perform thorough risk assessment that will be discussed with customers, execute engineering batches, create PPQ protocols, and batches and generate submission relevant reports.

    With Lonza’s own drug product manufacturing facility going live in 2021, disposable technology in compounding and filling will be implemented, tightly integrating the development and GMP offering including fully representative setup (Freeze dryers, disposables, fill) for process development.
  • Lonza DPS offers clinical and commercial drug product GMP manufacturing of highly potent small molecules both as liquid and lyophilized products. This is at approved and qualified third parties.

    Lonza’s experienced DPS team will perform thorough risk assessment that will be discussed with customers, execute engineering batches, create PPQ protocols, and batch records,  generate submission relevant reports and can provide regulatory consulting and submission preparation.
  • Deviations are not uncommon during manufacturing, and root-cause investigations (RCIs) are necessary to identify the underlying causes, followed by putting the correct corrective and preventive actions in place. Many times, such RCIs are time-critical and require wide expertise and sound scientific knowledge are often required to rapidly identify the underlying causes. Lonza’s Drug Product Services team can support with a huge variety of challenges that may be encountered during development and/or drug product manufacture. Our experts can support assessments, RCIs and generate required data to support.