Formulation & Process Development

The development of new pharmaceutical product is a core activity at Custom pharmaceutics which must be performed consistently and in accordance to established pharmaceutical guidelines. These include, but not limited to:

• ICH Q8 Pharmaceutical Development
• ICH Q9 Quality Risk Management
• ICH Q10 Pharmaceutical Quality System
• ICH Q14 Analytical procedure development
• FDA Guidance for Industry

The aim of NPI development at Custom is to design a quality product and its manufacturing process to consistently deliver its intended performance, described by the Quality Target Product Profile (QTPP). The information and knowledge gained from the development activities provide the scientific understanding to support the establishment of the product specifications, and the drug product control strategy.

New product development at Custom follows a risk-based approach where formulation attributes and process parameters are assessed based on the extent to which their variation can have impact on the quality of the Drug Product Critical Quality Attributes (DP CQAs). As the product knowledge increase over the development lifecycle, the risk assessment is reviewed and updated, and additional activities are planned to mitigate any outstanding risk until a product control strategy is defined and fully data supported.

Formulation development goes through several stages that are aligned to the clinical programme:

• Quality Target Product Profile definition
• Formulation Design and Process Selection
• Process Optimisation and Control Strategy Definition
• Process Validation

In the early stages formulation development Custom can accelerate the early clinical programme by formulating simple drug in capsules, using our Quantos dispensing technology, whilst also generating data to support further development for future clinical phases.

With our clinical and commercial capabilities we can take a project on at any stage of the product lifecycle, from pre-clinical or Phase 1 as well as during the later stages of development for phase 2/3 and launch.

Our formulation development starts with the end in mind: we work with you to define your drug product Quality Target Product Profile.

Predictive tools compaction simulators, ASAP, expertise in packing selection and controls.

• API solubility assessment
• API material characterisation
• API developability
• Excipient compatibility
• Solid form screening and characterisation

Our scientists follow a Quality by Design methodology, utilising risk management tools to develop high quality formulations with robust and reliable manufacturing processes.

We use well-designed and executed experiments to generate high quality data, enabling effective decision-making and reducing risks as the development progresses.

Our facilities include a formulation development laboratory and a GMP pilot plant operated by dedicated, experienced technicians and formulation scientists.

This provides us with the unique requirements for your product and allows us to take a ‘molecule first’ approach to development.

Drugs are seldom administered to patients as pure compounds, instead they are formulated into medicinal products: but many that start their development journey don’t make it to market, failing for a variety of reasons from inefficacy or toxicity to commercial or manufacturing problems. We help spot those potential pitfalls early by investigating the physical and chemical properties of drug substances (in isolation or in combination with excipients), identifying early predictors and generating information vital to the formulator in developing stable and safe dosage forms with good bioavailability.

“The team at Custom are flexible, pragmatic and a pleasure to work with. Apart from being timely in responding, Custom works to a high standard and they are also very transparent which builds trust.”

Our scientists follow a Quality by Design methodology, utilising risk management tools to develop high-quality formulations with robust and reliable manufacturing processes.

We use well-designed and executed experiments to generate high-quality data, enabling effective decision-making and reducing risks as the development progresses.

Our facilities include a formulation development laboratory and a GMP pilot plant operated by dedicated, experienced technicians and formulation scientists.

• Solid oral dosage forms (Tablets, Capsules and Powders)
• Modified release
• Age-appropriate formulations e.g., paediatric
• Bio-enhanced formulations
  • Amorphous solid dispersions, including spray drying
  • Co-crystal preparations
• Process Development and Optimisation
• Process Scale Up