Drug Product
We recognize the importance of our clients’ requirement to develop robust and compliant formulations. With our analytical development services supporting our pre-formulation work, we can perform full physico-chemical characterization using modern analytical techniques in-house for rapid turnaround times.
We specialize in working with customers to understand their needs and develop the best possible formulation. All formulations are developed via a science-based approach, whereby considerations of API solubilization capacity, bioavailability and manufacturability are carefully balanced.
Formulation Development
- Formulation development for new chemical entities (NCE)
- Optimization of existing formulations
- Feasibility Studies
- Excipient Compatibility selection and optimization
- Physicochemical Testing
- Process Scale-Up
- Technology Transfers
- Batch manufacture as per GMP guidelines
Stability studies
Stability studies are an essential component of pharmaceutical development. At Biopin-Aambal, we have the capabilities to evaluate drug stability in a range of environmental conditions with changes in humidity, temperature and light.
We can execute:
- ICH stability studies and testing
- Accelerated studies
- Photostability studies
- In-use stability studies
- Ongoing stability studies
Manufacturing
Our manufacturing partners offer non-GMP and GMP drug product manufacturing services in a variety of dosage forms, including:
- Oral tablets
- Oral solutions and (nano-)suspensions
- Topical products
- Powder and granule-filled capsules
- Semi-solid and liquid-filled capsules
- Self-emulsifying drug delivery systems
- Nano-carrier drug delivery systems
Small-scale manufacturing services are available and we offer:
- Preclinical batches
- Non-GMP pilot batches
- GMP clinical supplies
- Validation batches
