Development Services

Through our off-shore affiliates, Stason offers API synthesis that includes custom manufacturing of organic molecules from milligram to kilogram quantities. Stason also develops new processes for the synthesis of target molecules, including biotransformation processes for the preparation of chiral molecules. Additional services include:

• Custom manufacturing of chemicals in kilogram quantities.
• Optimization of existing synthetic processes or methods.
• Screening biocatalysts for the resolution or asymmetric synthesis of drug molecules and development of biotransformation process.

Stason manages qualified API plants, and has sourced & qualified a number of ingredient providers. We maintain a comprehensive list of pharmaceutical/chemical raw material, and product intermediates. This list includes items for pilot, clinical and commercial quantities. In addition, we have access to sophisticated raw materials and excipients. Should you require a chemical raw material that is not on our list, we can identify and qualify a suitable vendor.

Characterization studies for your product can be conducted prior to formulation. Pre-formulation is a critical activity often overlooked in the development of new or existing medicines. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development. These include:

• Polymorphism
• Excipient-Excipient Compatibility
• API-Excipient Interaction Studies
• pKa/Log P Determination
• Hygroscopicity Studies
• Phase Solubility Determination
• Photostability of API
• Degradation Pathway Determination
• Matrix Stability Evaluations
• Container-API interactions
• Prototype Evaluations
• Particle Size/Solubility Studies

Please contact us for a customized plan for the design and execution of a pre-formulation study, to meet your development objectives.

Reliable and reproducible analytical methods are essential to both the pharmaceutical development process and the evaluation of drug product to meet the standard of potency, purity and stability. Analytical chemists will work to develop, qualify and validate methods, or refine existing analytical methods to meet these demands. We also have a DEA analytical permit for CII-CIV products.

• Method development, validation and routine testing.
• Identity, quantitation, potency, content uniformity.
• Process contaminants, impurities, degradants, excipients.
• Lot release and stability assessment.

The formulation strategy is the result of a thorough analysis of the pre-formulation data report, the intended manufacturing process, any patient compliance issues, and any strategic and regulatory goals of the company.

Comprehensive evaluation of drug candidates during pre-formulation is critical to the formulation development process. Certain candidates present specific challenges such as: low bioavailability, poor solubility and/or permeability, and poor physical stability. Formulation development can be helpful in overcoming many of these issues. Our approach includes:

• Pre-Formulation Solubility & Stability Evaluations
• Comprehensive Excipient Screening & Vendor Qualification
• Prototype Development
• Formulation Optimization & Finalization
• Identified Specification
• Supporting Documentation & Data Package in CTD/eCTD format meeting QoSr Requirements.

Most quality assessment today relies on end-product testing. However, the future of CMC review is based on Quality by Design (QbD), and the CMC Regulatory Decision is based on CMC Quality & Performance.

Based on our commercial production experience, we can provide advice on “Design for Manufacturability” and solutions to provide cost effectiveness in your final product. An optimized formulation assures efficient technical transfer, optimal stability and scalability.

If Scale-up and Post Approval Changes (SUPAC) become necessary for our clients, we will: develop cost-efficient strategies to ensure the acceptability of scale-up & post-approval changes, long-term stability commitment on post-change batches for new drug applications (NDAs) & abbreviated new drug applications (ANDAs)—per 21 CFR 314.70, and supplements & other changes to an approved application.

To facilitate process optimization and SUPAC needs, Stason will conduct a comparative study on the various types of supplemental amendments regarding SUPAC modifiers including: SUPAC-Immediate Release solid dosage forms (SUPAC-IR), and SUPAC Modified Release oral dosage forms (SUPAC-MR). Once this study is completed, we will develop strategies for changes that need an approved supplement, but may be submitted as changes being effected, or in the next annual report under the SUPAC terms. We will validate the changes, and with our expert regulatory personnel, provide a mechanism to obtain substantial regulatory acceptance of the post approval changes.