Sterile Formulation Development

Source: PCI Pharma Services

With over 20 years of experience, PCI’s strength lies in our ability to manage products with unique challenges ranging from small molecules presenting with solubility issues or a labile molecule that is only stable as a liquid presentation for a short time.

Whether you are developing a liquid or lyophilized dosage form, we understand that speed and flexibility are critical to the success of your development program. We can screen multiple experimental formulations in parallel to expedite the formulation development phase of your program to enter the sterile fill-finish step. We focus on developing reproducible, scalable, and commercially robust processes, delivering time and cost efficiencies.

Sterile Solubility and Stability

Using a Quality by Design (QbD) approach, we start by performing a pre-formulation study or by leveraging existing data you may have to understand the key physical characteristics of your product. From this understanding of the chemical properties of the molecule we are able to develop the strategy for the development program.

Key studies of your development program may include:

  • Pre-formulation
  • In-use (Bulk) stability
  • Mixing / shearing
  • Order of addition
  • pH ranging
  • Solubility
  • Material compatibility
  • Filter adsorption
  • Freeze/thaw
  • Tonicity (SQ/IM)

Analytical Testing

Our in-house GMP analytical laboratories provide full analytical testing services for your formulation development programs. 

Testing capabilities include:

  • Analytical & microbiological testing
  • In-process & release testing
  • ICH stability & Q1B photostability
  • Analytical method development
  • Method transfers & phase appropriate validation