Development

Development

Whatever your drug product entails in production, we want to ensure it makes it to clinic as soon as possible and with the highest quality result achievable. Our staff will help you with your method, formulation, or lyophilization development to ensure your product is has a smooth transition to production. 

Formulation Development

We offer first-in-human formulation development, supply material for preclinical studies, and conduct research-level stability studies. BSM can also offer formulation optimization, process development, process optimization, and scale up studies. Our process engineering team will perform formulation development using materials and equipment representative of future GMP manufacturing.

Information gathered during formulation development is shared with BSM’s quality control group to allow them a head start in their analytical method feasibility, evaluation, and development.

Lyophilization Development

We have both a clinical-scale and commercial scale lyophilizer, capable of filling up to 3,500 10R vials and 35,000 10R vials respectively. To complement this service, we also offer lyophilization development for clients looking to optimize their lyophilization cycle or simply those interested in freeze-drying their product.

We can develop your lyophilization formulation, lyo cycles based on thermal properties, and scale-up the lyo process when you move on in your clinical trials or to commercialization.  We also offer the unique ability to handle the development through commercialization to finalize your process for a successful commercial presentation.

Method Development

BSM is capable of designing methods to obtain desired analytical measurements with the appropriate characteristics. During method development the accuracy, precision, linearity, and specificity will be assessed as well as system suitability requirements. Our team will provide a development report detailing the laboratory work that was performed and expectations for performance of the method. A draft test method will also be provided.

Following method development, BSM can perform method qualification or validation, as appropriate for the development phase of the product.

Upcoming Webinar:

Wednesday, June 1st | 1PM EST

Enhancing sterility assurance in isolator-based aseptic filling