Development

PMI Bio provides services to support the pharmaceutical development of new formulations or optimize existing formulations. We strive to identify product complexities in order to provide cost-effective developmental work for your compounds. Our capabilities include pre-formulation, excipient and formulation studies of parenteral, oral, topical, and lyophilized formulations, and vehicle delivery studies for poorly water-soluble APIs (e.g.: emulsions or suspension).

Formulation

We design formulation studies with attention to the details, from the use of ingredients, to identification of potential stability problems, compatibility with container/closure systems, and stability of the API under the conditions of pharmaceutical manufacturing.

Capabilities:

  • Solubility
  • pH
  • Degradation
  • Potency
  • Thermal Analysis
  • Liposome and microsphere encapsulation
  • Critical process parameters evaluation
  • Admixture and container/closure compatibility studies
  • Development report in support of CMC
  • Excipient Compatibility Studies

Dosage Forms:

Liquid Formulation Development

  • Parenteral and Oral
    • Solutions
    • Suspensions
  • Topical Solutions

Semisolid Formulation Development

  • Creams
  • Ointments
  • Gels

Our experience helps our clients develop formulations that work within the increased scrutiny of today’s regulated environment.

Analytical Development

Whether starting from scratch or optimizing a client provided method, we create solutions customized to your needs and support that method during each step of the drug approval process. Using compendial or non-compendial methods, we test your product from the raw materials phase to the finished product/end phase.

Capabilities:

  • Develop new analytical methods and define a starting point for analytical lifecycle management
  • Establishment of product and process specific methods to support process development
  • Development of additional characterization methods for reference standards, etc.
  • Method Transfer
  • Method Optimization
  • Method Qualification
  • Method Validation

Process Development

Our highly skilled team works to provide the process solutions to meet your needs by supporting process changes and scale up as products progress through clinical trial phases. We strive to develop robust processes which consistently produce high-quality products on time every time. Our core competencies include but are not limited to manufacturing process design, optimization, and scale-up.

Development Stability

  • Pilot batch production and stability analysis
  • Microbiological Testing
  • Determination of stability indicating methods
  • Stability Screens
  • Stability storage and testing