FORMULATION & PRE-FORMULATION
BioKey offers pre-formulation & formulation development services to help clients determine optimal dosage levels for therapeutic formulations in oral solid (tablets and capsule) and liquid forms.
Pre-Formulation
The BioKey team has extensive experience in a wide range of pre-formulation studies that generate useful data for developing stable and bioavailable dosage forms. These studies include:
- Physiochemical characterization
- Compatibility studies
- Powder & granular characterization
Formulation Development
The BioKey team has extensive experience on a wide range of pre-formulation studies that generate useful data for developing stable and bioavailable dosage forms. These studies include:
- Physiochemical characterization
- Compatibility studies
- Powder & granular characterization
Key Capabilities
- We currently have capability for formulation development of non-sterile solutions, semisolids (gel, cream and ointment), and solids (powder, tablets, and capsules) in our R&D lab and then manufacture of developed drug product in GMP pilot plant.
- Our equipment typically supports batches of up to 25 Kg, although larger batches are possible depending on the products. Small batches are possible for early development studies.
- We are experienced in the development of botanical and nutritional supplements with the possibility of production in our food product pilot plant. We also are able to conduct packaging for systems like metered dose pumps, pouches, and bottles.
- We can store bulk, unlabeled package (bulk packaged) and clinically labeled clinical materials in our GMP area. Upon instructions from the client, we will prepare the necessary patient supplies and ship to the specified site. If required, we will package and label the bulk or bulk packaged material according to a protocol supplied by the client
Additional Capabilities
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BioKey can develop a formula and process for the experimental product for phase 1 and 2 studies. We typically can make batches in our GMP pilot plant. If a formula/process exists, we can transfer it to our facility.
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We work closely with our clients to establish raw material test methods, in-process test methods, and finish product test methods and their corresponding specifications. We also work collaboratively with our clients while generating a Master Batch Record and a Master Packaging Record for the product manufacturing and filling.
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We are able to package and label the bulk material to conform to the need of the clinical trial protocol.
