Development of Custom APIs

Economic pressures are driving an ongoing shift in pharmaceutical product development as companies strive to improve return on investment and speed time to market. Choosing the suitable active pharmaceutical ingredient (API) is critical to the success of any project, making early and comprehensive characterization an absolute requirement.

API's detailed physicochemical characterization helps manage and mitigate the uncertainty and risks inherent in early-stage drug development. Win fast, fail fast approaches are critical to long-term success, allowing rapid identification of APIs that can be developed that meet likely processability, bioavailability, and safety requirements.

Custom API with AbbVie

AbbVie Contract Manufacturing combines experience in custom API development, discovery, and manufacturing with a deep understanding of how to apply physicochemical analysis in drug development. Used throughout the pharmaceutical development workflow, our systems help answer questions about API stability, bioavailability, and quality to support, and processability:

* Selection of viable candidates

* Understanding Critical Material Attributes (CMA)

* Implementation of quality scaling in API manufacturing

* Application of quality by design (QbD) by defining the physicochemical design space

API developers can equally gain access to unique and personalized professional backing to help quickly identify the right medicine candidates via Amplify Analytics and a highly flexible and scalable range of services.

Physicochemical analysis for early decision-making

 1. API Bioavailability

The low solubility of most current APIs adds to the complication of seeing to it that a molecule has sufficient bioavailability for practical use. Methods such as the Developmental Classification System (DCS) and the Manufacturing Classification System (MCS) help identify candidate molecules that are susceptible to meeting bioavailability necessities and will succeed in scaling up and manufacturing.

Common strategies used in API strategy to advance solubility consist of size reduction of particles, identification and selection of different polymorphs, and use of amorphous forms of the molecule.

AbbVie Contract Manufacturing help answer the following questions:

* What solid shapes are available?

* Are there multiple polymorphs?

* What is the impact of particle size reduction on the stability of the particles and the polymorph?

* The amount of amorphous content that is present, and how amorphous structures can be characterized and defined?

2. API Stability

Understanding API stability in a robust way is an essential part of lead candidate optimization, sodium screening, and process development. Polymorphic transitions can cause changes, such as altered dissolution rates, reduced drug efficacy, and possible adverse reactions, and their presence can lead to patent issues.

Therefore, the selection of polymorphs and the verification of polymorphic steadiness with time are crucial. This gets more crucial when selecting an amorphous form of the API to increase solubility, as unpredicted crystallization of an insoluble form can be lethal.

Ensuring that all polymorphs are known, and their behavior is understood helps manage API stability and reduce the risk of late polymorphs that could jeopardize further development.

AbbVie Contract Manufacturing help answer the following questions:

* What polymorphic forms of the API are possible?

* How will these polymorphic forms behave?

Contact us today for your custom active pharmaceutical ingredients.