Our Protocol Driven Process

At Summit Biosciences, we leverage more than a decade's worth of spray-specific approaches for product development. A protocol-driven process enables adherence to ICH principles of a Quality-by-Design philosophy.

Formulation Development

We are equipped to handle the unique challenges presented by solution and suspension development for sprayable drug product development, including:

  • Controlled substance handling
  • Inert-gas processing in early development stages
  • Small-scale filling capabilities
  • Core Competency over an archive of spray development excipients

Efficient and Collaborative Analytical Method Development

Close collaboration among our talented scientists results in efficient analytical methods development, API characterization, evaluation of raw material grades, solubility testing, excipient compatibility, and API forced degradation and stability testing.

Commercially-Ready Sprayable Drug Products with Built-In Quality

Based on Quality Target Product Profiles (QTPP), we use a scientific approach for formulation development (i.e., statistical design of experiments) while controlling for a number of spray-specific parameters as follows:

  • Patentability
  • pH
  • Stability
  • Osmolality
  • Viscosity
  • Sprayability
  • Robustness
  • Processability

Quality Control - Chemistry

Our Analytical Development, Validation and Testing include:

  • Raw material release
  • Spray characterization development and validation
  • HPLC development and validation
  • Gas chromatography
  • ICH stability study design

Raw Material Release

  • DEA approval for handling Category I-IV materials
  • Development of customized or compendial based specifications
  • Raw material release testing
  • Applicable to API, excipients, actuator components, tubing, filters, other materials unique to a program

Spray Characterization Development and Validation

We offer the full complement of guidance recommended and required spray characterization testing including:

  • Development of automated actuation parameters that utilize manufacturer's recommendations as appropriate with product-specific optimization to achieve robust and reliable results
  • Automated actuations performed using the Proveris Vereo® actuators
  • Malvern Spraytec® used to perform droplet size distribution testing
  • Proveris SprayVIEW® used to perform spray pattern and plume geometry testing
  • Eight stage inertial impactor with USP expansion chamber used to perform drug in small droplet
  • Spray content uniformity performed by assay or by weight

HPLC Development and Validation

  • Compendial method verifications
  • Transfer of validated methods
  • Full development and validation
    • Forced degradation evaluation for stability-indicating methods
    • Applicable to both drug substance and drug products
    • Optimization of methods for assay only requirements for testing such as cleaning sample verification or spray content uniformity analysis

ICH Stability Storage and Study Design

  • Controlled and 24/7 monitored DEA-approved chambers
    • 25°C/60%RH
    • 30°C/65%RH
    • 40°C/75%RH
    • 5°C
  • Extra capacity for unique storage conditions
  • Protocol based stability study design
  • Management of stability program

Quality Control - Microbiology

We offer the full complement of recommended and required microbiological testing including:

  • Method development and validation
  • Bioburden testing of components and in-process bulk product
  • Microbial enumeration tests (USP <61> or EP)
  • Tests for specified microorganisms (USP<62> or EP)
  • Sterility testing per USP <71> or EP
  • Delamination tests
  • Container closure integrity testing
  • Environmental monitoring (e.g., airborne and surface bioburden)
  • Sterilization validation of autoclave cycles

Quality & Regulatory Support

We offer Quality and Regulatory guidance and support for projects from development through commercialization for the following areas:

  • Vendor qualifications
  • Quality agreements
  • Risk assessments
  • DEA compliance services for Schedule I-IV materials
  • Support of annual product reviews
  • Validation master plans
  • CMC development
  • Annual Reports
  • FDA correspondence
  • Regulatory life cycle maintenance

Stability Testing

  • Full capability for stability testing
  • ICH and custom conditions
  • Stability storage, administration and testing