Parenteral Drug Product Formulation Development

Life-cycle management and line extension formulations

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.

Early-stage services

Our early-stage pharmaceutical development formulation is supporting a fast to clinic approach while also considering the future commercial image and target product profile. We tailor the early-stage formulation strategy according to the molecule format, type and specific sequence. Our approach aims to guarantee significant speed, whilst ensuring quality, never compromising patient safety 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.

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

Late-stage services

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 robust, in relation 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 and potential integration with a parenteral device such as autoinjector or pump are just a few considerations for a robust formulation.

Our formulation experts have deep knowledge and hands on experience in developing formulations for commercialization.

Formulation robustness testing

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.

Life-cycle management and line extension formulations

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.