CMC - Product Development & CTM Manufacturing

Let Frontage help move your pharmaceutical product development program from the preclinical phase into clinical development with expert organic synthesis, preparation and testing of your active pharmaceutical ingredient (API) or organic compound for administration in vivo.

Operating under current Good Manufacturing Practices (cGMP), the Frontage manufacturing facilities are designed with the goal of producing solid oral dosage forms, as well as semi-solid, liquid and sterile products ranging from a few units up to 140 kg for solid dose, 300 kg for semi-solid and liquids and up to 20 liters for aseptic processes.

Our scientific and regulatory consulting group can provide the expertise needed to support the filing of INDs, NDAs and ANDAs with the Food and Drug Administration. Additionally, Frontage scientists have the required knowledge and expertise to support the technical transfer of the process and analytical methods to a sponsor’s facility.

Preclinical/Early phase Formulation Development

After selecting a lead drug candidate, you may face several hurdles to ensuring the successful delivery of the molecule to the target site of treatment. Common challenges are often due to the physico-chemical properties of the drug substance itself.  These include solubility, membrane permeability, stability and interactions with formulation excipients.

With our innovative approach, Frontage excels at solving complex problems with speed and efficiency.  When it comes to formulation development, we have helped clients develop rational and creative strategies by incorporating Quality by Design (QbD) principles.

Finished Product Development

Frontage understands that the correct formulation is critical to the success of your drug candidate. Our staff of skilled scientists bring broad experience and a history of success delivering many complex formulations. We take a collaborative approach with our clients and treat each project uniquely, exploring multiple technology platforms in order to increase the rate of success for each product.

Preformulation studies at Frontage are designed to identify the best form of the drug substance, evaluate its physical properties and learn about its stability. These studies are designed to identify and select the optimal dosage form of your API. Common formulation development and pre-formulation studies include:

  • API-excipients compatibility
  • pKa
  • Log P
  • Solubility in various media and solvents
  • Thermal characterization
  • Droplet size distribution
  • Wettability
  • Density
  • Polymorphic forms
  • Partition coefficient
  • Stability under various conditions
  • Particle size distribution

Frontage has significant experience in developing a wide variety of dosage forms with different processing techniques including:

Oral Solids/Liquids

  • Neat API capsules
  • Powder in capsules/vials
  • Modified release tablets and capsules: extended or delayed release
  • Immediate release tablets and capsules
  • Bi-layer tablets
  • Mini tablets
  • Orally disintegrating and chewable tablets
  • Solutions, suspensions, and reconstituted powders

Topical Semisolids

  • Creams
  • Ointments
  • Gels
  • Sprays

Injectables

  • Solutions
  • Ophthalmic drops
  • Nasal sprays
  • Micro/nano Emulsions
  • Lyophilization (cycle development, phase transfer studies and scale-up)

Quality by Design

Using QbD principles in the drug development process leads to quick prototype development as critical knowledge is gained up front.  This knowledge includes the product attributes, process parameters, material attributes and operation controls required for the formulation and its manufacturing process.

Frontage helps clients implement a rational, stepwise approach to QbD throughout the preclinical and clinical stages of product development. In turn, this approach allows the development team to create an optimized formulation and a robust, scalable process earlier in the timeline. This approach may also avoid the potential for clinical failure of the candidate due to bioavailability or absorption issues.

To achieve these advantages, partner with Frontage team members who are familiar with implementing the QbD concepts in various types of product development programs and have a proven track record of successfully scaled-up processes.  Allow us to add efficiencies and effectiveness to your drug development program.

GMP Manufacturing - Clinical Trial Materials

Flexible, fast and precise, Frontage operates under current Good Manufacturing Practices (cGMP) to produce Phase I & II Clinical Trial Materials in small to large batch sizes with quick scale up to fit your early phase clinical needs.

The cGMP manufacturing facility is designed to produce solid oral dosage forms, as well as semi-solid, liquid and aseptically filled liquid and powder sterile products containing either non-potent or potent compounds.

The Frontage Clinical Trial Materials team develops oral solid dose, liquids (ophthalmic drops and injectables), as well as alternate dosage forms such as nasal sprays.  For more detail, see our Finished Product Development page.

Each of our skilled scientific staff members have significant industry experience and training from the bench to the marketplace. This expertise, combined with our team’s commitment to the success of your project, simplifies the implementation and scale-up of any process.

Frontage is a FDA registered lab with a DEA license for Schedules I-V controlled substances.