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Analytical Laboratories

The leading laboratory for solving complex stability and formulation challenges using world-class science to speed products to market.

Why Work With FreeThink’s Analytical Team

FreeThink is the leader in all aspects of stability/shelf life development, including sponsoring the premier scientific stability conferences. Our advanced accelerated stability software package ASAPprime® is used by most pharmaceutical companies globally. Our scientists publish extensively and are world-class experts in stability.

Our analytical team develops phase-appropriate, stability-indicating methods that quantitatively capture changes in critical quality attributes (CQAs) including chemical (potency, degradation products) and physical (dissolution, crystals growth, polymorph forms, viscosity, appearance) changes using state-of-the-art instrumentation. We quantitatively determine kinetics at a range of statistically designed conditions (temperature, relative humidity, oxygen level) to enable sophisticated stability modeling for shelf life.

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Analytical Laboratories

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Analytical Laboratories

Accelerated Chemical Stability

Accelerated Physical Stability

Analytical Method Development

Traditional Stability

Analytical Laboratories

Accelerated Chemical Stability

Accelerated Physical Stability

Analytical Method Development

Traditional Stability

Accelerated Chemical Stability

FreeThink generates experimental data at a range of statistically designed, highly accelerated conditions to model (using ASAPprime®) the shelf life of products based on CQAs. FreeThink’s scientists are experts at conducting such studies for many purposes, including determining packaging and solving stability problems. Products (solids, liquids, semisolids) include active pharmaceutical ingredients, drug products (small molecule and biological), and consumer products. Our Accelerated Stability Assessment Program (ASAP) studies can be carried out at three levels:

  • Standard ASAP: Analytical methods verified for use, but no formal method transfer or validation necessary. A final report includes details and recommendations.
  • QA Reviewed ASAP: Includes a Quality Assurance (QA) review and signature for all data in the report.
  • Full cGMP ASAP (recommended for market applications (NDAs and ANDAs) and post-approval filings): All work adheres to FreeThink’s SOPs with instruments qualified; analytical methods transferred according to formal protocols; data and reports certified by FreeThink’s experienced QA staff. Customers are invited to audit FreeThink’s quality systems and meet the scientists and QA professional staff.

Accelerated Physical Stability

Shelf life is based on increases in a CQA, whether this be growth of something undesirable (degradation products, color) or decreases in something desirable (activity or potency, dissolution rate).

FreeThink develops analytical methods for quantifying these changes for a wide variety of pharmaceutical and non-pharmaceutical products, including those with multiple actives, actives with no chromophores, and materials with difficult separations.

Developing a stability-indicating method often entails exposing actives to stresses for hydrolytic, oxidative, thermal, and photolytic sensitivity, then developing appropriate methods, most commonly HPLC, UPLC, or GC.

FreeThink scientists are adept at:

  • Screening multiple column chemistries.
  • Varying eluting solvents and gradients to achieve separations based on a phase-appropriate approach: minimal optimization through full optimization/validation.
  • Using charged aerosol detector (CAD), evaporative light scattering (ELS), or MS detection, adjusting the eluting solvents accordingly when the active has no chromophore.

Click here to view a Freethink presentation on developing stability indicating methods.

Analytical Method Development

Physical factors can be CQAs that limit product shelf life. FreeThink scientists develop analytical methods and use statistically designed accelerated stability conditions (open exposure to a range of temperature and relative humidity) to build a stability model for the product. This model can be essential for formulation design and packaging selection. We have experience developing methods and predicting stability for such physical factors, as:

  • Dissolution/disintegration
  • Viscosity (Brookfield viscometer)
  • Appearance (colorimeter)
  • Amorphous solid dispersions crystallization (PXRD, DSC)
  • Hardness, stickiness (texture analyzer)

Traditional Stability

In addition to the highly accelerated stability studies that we are well known for, FreeThink can perform traditional ICH stability studies on drug substances and drug products. These studies can be carried out for information purposes or under full cGMP quality systems.

  • Available qualified chambers include ICH long-term and intermediate (25°C/60% RH, 30°C/65% RH), accelerated (40°C/75% RH), Zone IVb (30°C/75% RH), and refrigerated (5°C) conditions.
  • SOPs cover all operations, all instrumentation fully validated, all staff fully trained.
  • Analytical testing includes most standard techniques (HPLC, GC dissolution, KF).
  • Experienced staff can assist with protocol design and report generation compliant with international regulations and guidelines.
  • Customers are invited to audit FreeThink’s quality systems and meet the scientists and QA professional staff.

FAQs

Q: What instrumentation does FreeThink have?

A: FreeThink’s laboratories are equipped with advanced systems for chemical and physical analyses, including:

  • Chromatographic Systems: HPLC, UPLC, and GC with UV-Vis (PDA), MS (QDA), charged aerosol (CAD), and flame ionization (FID) detectors.
  • Physical Characterization Tools: Moisture sorption (DVS), thermal properties (DSC), solid forms (PXRD), mechanical properties (texture analyzer), and viscosity measurement (Brookfield).
  • Additional Capabilities: Standard dissolution, disintegration, hardness, and friability testing.

To learn more about how our laboratories can support your project, contact us [here].

Q: Can FreeThink do ASAP studies under GMP?

A: Yes, FreeThink’s laboratory is GMP-registered, FDA-inspected, and regularly audited by customers. We follow established SOPs and have qualified all equipment and software required for GMP-compliant ASAP studies. All personnel involved receive regular training to ensure quality standards.

Learn more about our GMP-compliant capabilities [here].

Q: Can FreeThink handle the setups and modeling while we (or our CDMO) manage the analytical work?

A: We generally cannot rely on data generated by other companies. While we are open to discussing options, we prefer to conduct studies in our laboratories to maintain data quality and consistency.

Interested in collaborating? Contact us to discuss your project [here].

Q: What makes FreeThink’s laboratories special for stability-indicating method development?

A: Stability (shelf life) is the primary focus of our analytical laboratories. Our semi-automated process for developing stability-indicating methods is efficient and effective, ensuring robust results.

Learn more about our stability-indicating method development process [here].

Q: Can FreeThink also accelerate physical stability?

Yes, we can accelerate most physical stability factors, including:

  • Dissolution/disintegration for tablets and capsules.
  • Viscosity, appearance (color), and physical form (e.g., amorphous dispersion crystallization).
  • Hardness (tablets).

However, ASAP is not suitable for particle growth in solution (Ostwald ripening) or microbial growth, though we can accelerate preservative loss and probiotic viability.

Contact us to learn how we accelerate physical stability testing [here].

Q: Does FreeThink handle biotherapeutics?

Yes, we use accelerated aging processes for protein and nucleic acid-based drugs such as peptides, monoclonal antibodies, antibody-drug conjugates (ADCs), fusion proteins, small interfering RNAs (siRNAs), antisense oligonucleotides (ASOs), aptamers, or microRNAs (miRNAs). We rely on robust analytical methods to measure key attributes.

Contact us to learn how we can assist with biological drug stability [here].

Q: Can FreeThink work with high-potency compounds?

We have worked with customers to handle accelerated stability on a number of high potency drug products. Our labs have limited containment options but can accommodate pre-weighed, septa-closed vials for high-potency compounds.

Have questions about high-potency studies? Reach out to our team [here].