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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.

Highly-concentrated formulations provide drug product developers benefits including enabling subcutaneous self administration and successful intraviteral injections. However, these formulations provide challenges such as container closure system compatibility and manufacturing.
  • Development of Target Product Profile (TPP)

    The target product profile (TPP) serves to provide a format for discussions between a pharmaceutical company and health authorities, that can be used throughout preclinical and clinical development  towards commercialization as well as postmarketing activities. The TPP aims to define the future desired product elements and aspects, that development should strive for. These include overall intent as well as details, including elements relevant for parenteral product development such as indications and usage, dosage and administration (route, e.g., intravenous, subcutaneous, intravitreal, intrathecal, interarterial, and administration volumes), dosage forms (e.g., liquid, lyphilisate) and strengths, primary packaging and device (e.g., vial, syringe, autoinjector, pen in cartridge), storage and handling.

    Our Drug Product Services team helps our customers in defining the TPP, and to tailor the ideal development strategy from a Drug Product perspective, to ensure a robust commercial product in the end, with a most suitable development strategy related to speed but also quality and chance-of-success.

  • Early-stage Pharmaceutical development aims to very quickly develop a formulation that is appropriate for use in preclinical (GLP) studies, early-stage clinical studies (e.g., Phase 1, 2a) and considering the future commercial image and target product profile. Time to Entry-Into GLP Tox and time to IND filing and first Clinical Study start is key, however safety of healthy volunteers, and insurance of product quality to ensure representatives of material is most important. Based on formulatibility and/or information provided by our customers, we tailor the early-stage formulation strategy according to the molecule format, type and specific sequence, in order to guarantee significant speed, whilst ensuring quality and never compromising patient safety, and by having late-stage development and commercialization in mind. Lonza’s formulation strategies consider not only stability, but also TPP-relevant primary packaging as well as drug product manufacturing process designs and patient use.

    Early-stage formulation options are based on our unmatched experience and prior knowledge, and each program outline is discussed and agreed with our customers prior execution. As dosage forms, liquid dosage forms are usually preferred, but freeze-drying (lyophilisation) is also employed where required.

  • Late-stage Pharmaceutical development aims to ensure that the Drug Product design intended for pivotal clinical studies (e.g., Phase 3) and filing of BLA/MAA and commercialization is adequately robust, with regard to stability, but also all other elements of the TPP, including administration and use. The appropriate design of dose strength per unit dose container, appropriate selection and qualification of primary packaging, potentially, the integration with a parenteral device such as autoinjector or pump are just a few considerations for a robust formulation.

    As dosage forms, liquid dosage forms are usually preferred, but freeze-drying (lyophilisation) is also employed where required.

    Our Drug Product Services team has a history of having developed a number of formulations for commercialization.

  • Since the Drug Product must be sufficiently robust for commercialization, it is important to evaluate and study all its parameters and assess them for criticality. This includes choices of excipient suppliers and related excipient quality, choices of primary packaging and related quality, as well as evaluating the impact of qualitative and quantitative changes in the composition (potentially critical formulation parameters), within normal operating ranges during manufacture as well as beyond on the products critical quality attributes (CQA). Such formulation robustness studies support product understanding, evaluating design space and threshold of potential failure, failure modes and finally, setting relevant specifications for the product lifecycle and health authority submissions.

  • Formulations and drug products may undergo further improvements as life-cycle management and line extension activities. For example, it may be found after actual development, that subcutaneous use may be more advantageous over intravenous use, requiring a new formulation to be developed and launch, or finding that a syringe and autoinjector may be preferable and should be launched in addition to a standard vial configuration. These line extensions can help to improve patient convenience and use, may provide competitive advantages and provide options for intellectual property.

    Our Drug Product Services team has experience in evaluating and suggesting options for parenteral product line extensions and life-cycle management and support in developing and launching these.

Formulation of Biologics from Molecule Selection to Clinical Studies

Learn ways to manage the challenges while taking advantage of the benefits afforded by high concentration formulations. Download the Presentation