Consulting
Do you have a problem with your material or product and don't know where to start? Need help finding a contract laboratory for your solid form studies?
Seventh Street Development Group has extensive experience in early and late development projects, as well as marketed products. We readily integrate with your team, other consultants, and your contract research/manufacturing organizations to get your project completed on time.
Our strong connections to consulting networks enable us to pull in additional expertise, such as formulation, process chemistry, project management, and others, when it is needed.
Our areas of expertise include:
- polymorphs
- salts
- cocrystals
- amorphous
- amorphous dispersions
- active pharmaceutical ingredients (APIs)
- drug products
- excipients
- amorphous dispersions
Need help finding a contract laboratory for your solid form studies?
Do you have a problem with your material or product and don't know where to start? Need help finding a contract laboratory for your solid form studies?
Seventh Street Development Group can review your current data, recommend a strategy for solid form selection based on your development needs, gather relevant proposals, and help you choose a contract laboratory for your solid form studies, including:
An overview of selected Seventh Street Development Group consulting projects is given below.
Early Development
Salt/cocrystal screening to produce crystalline material
Goal: Find a crystalline material to take into early clinical studies.
Action: Worked with client and CRO on salt/cocrystal screen, and with client and API manufacturer in China on crystallization studies of amorphous API (active pharmaceutical ingredient).
Result: Found crystalline API forms suitable for early clinical trials.
Determination and scale-up of most stable form for early clinical studies
Goal: Determine most stable form and work with team to produce desired form at scale for clinical trials.
Action: Monitored abbreviated polymorph screening work at contract laboratory, interacted with API manufacturers in India and China during scale-up, compiled data for intellectual property filing.
Result: Produced kilogram scale Phase I clinical trial material.
Crystallization of amorphous material
Goal: Find a crystalline material to take into Phase II clinical trials.
Action: Worked with API manufacturer on crystallization and cocrystal studies of amorphous API (active pharmaceutical ingredient).
Result: Found crystalline API forms and cocrystals suitable for later stage clinical studies.
Selection of amorphous solid dispersion for early clinical studies
Goal: Choose an amorphous solid dispersion of a poorly soluble drug for Phase I clinical studies.
Action: Reviewed characterization and preformulation data on multiple amorphous solid dispersions to find suitable dispersion for early development, interacted with contract laboratory to put together the best characterization methods.
Result: Found a number of acceptable amorphous dispersions for development.
Survey solid forms for development of pediatric formulation for early clinical studies
Goal: Choose an acceptable solid form for a pediatric suspension formulation.
Action: Reviewed data on known forms including multiple anhydrous, solvated, and salt forms to suggest acceptable form for the formulation.
Result: Compiled all solid form data in easy to reference format and recommended a suitable solid form for the suspension formulation.
Salt/cocrystal screening to produce crystalline material
Goal: Find a crystalline material to take into early clinical studies.
Action: Worked with client and CRO on salt/cocrystal screen, and with client and API manufacturer in China on crystallization studies of amorphous API (active pharmaceutical ingredient).
Result: Found crystalline API forms suitable for early clinical trials.
Determination and scale-up of most stable form for early clinical studies
Goal: Determine most stable form and work with team to produce desired form at scale for clinical trials.
Action: Monitored abbreviated polymorph screening work at contract laboratory, interacted with API manufacturers in India and China during scale-up, compiled data for intellectual property filing.
Result: Produced kilogram scale Phase I clinical trial material.
Crystallization of amorphous material
Goal: Find a crystalline material to take into Phase II clinical trials.
Action: Worked with API manufacturer on crystallization and cocrystal studies of amorphous API (active pharmaceutical ingredient).
Result: Found crystalline API forms and cocrystals suitable for later stage clinical studies.
Selection of amorphous solid dispersion for early clinical studies
Goal: Choose an amorphous solid dispersion of a poorly soluble drug for Phase I clinical studies.
Action: Reviewed characterization and preformulation data on multiple amorphous solid dispersions to find suitable dispersion for early development, interacted with contract laboratory to put together the best characterization methods.
Result: Found a number of acceptable amorphous dispersions for development.
Survey solid forms for development of pediatric formulation for early clinical studies
Goal: Choose an acceptable solid form for a pediatric suspension formulation.
Action: Reviewed data on known forms including multiple anhydrous, solvated, and salt forms to suggest acceptable form for the formulation.
Result: Compiled all solid form data in easy to reference format and recommended a suitable solid form for the suspension formulation.
Late Development/Marketed Products
Characterization of a natural product for new regulatory filing
Goal: Collect additional data on a natural product for differentiation of materials and correlation to performance.
Action: Worked with contract laboratory to develop a step wise approach for the physical characterization of the matrix of the natural product and its effect on performance, along with the level of the active ingredient.
Result: New characterization methods for the matrix employed to show sameness of the natural product.
Review of data for investment opportunity
Goal: Determine if natural product/device combination is feasible for development.
Action: Reviewed scientific documents and compiled a list of considerations for a regulatory filing.
Result: Additional work suggested to ensure success of the investment.
Development of a quantitative solid form method for release of API in a marketed drug product
Goal: Develop a robust quantitative method for the desired form in the presence of two other crystalline phases.
Action: Worked with the client and CRO to develop and validate a quantitative method to submit to regulatory agencies.
Result: A robust quantitative solid form method was developed for API release and sucessfully submitted to regulatory agencies.
Review of physical stability data for NDA filing
Goal: Determine if crystal form changes had occurred during stability studies.
Action: Reviewed long term API stability data and compiled a statement for the regulatory filing.
Result: Documentation for NDA filing provided on the results of the physical stability study.
Compilation of solid-state data for patent application
Goal: Determine and compile the requisite solid-state form data to be included in patent.
Action: Reviewed screening, characterization, and crystallization reports to find suitable data for filing; interfaced with characterization laboratory and patent atttorneys to compile relevant data for patent application.
Result: Patent application on multiple solid forms was written and submitted.
Characterization of a natural product for new regulatory filing
Goal: Collect additional data on a natural product for differentiation of materials and correlation to performance.
Action: Worked with contract laboratory to develop a step wise approach for the physical characterization of the matrix of the natural product and its effect on performance, along with the level of the active ingredient.
Result: New characterization methods for the matrix employed to show sameness of the natural product.
Review of data for investment opportunity
Goal: Determine if natural product/device combination is feasible for development.
Action: Reviewed scientific documents and compiled a list of considerations for a regulatory filing.
Result: Additional work suggested to ensure success of the investment.
Development of a quantitative solid form method for release of API in a marketed drug product
Goal: Develop a robust quantitative method for the desired form in the presence of two other crystalline phases.
Action: Worked with the client and CRO to develop and validate a quantitative method to submit to regulatory agencies.
Result: A robust quantitative solid form method was developed for API release and sucessfully submitted to regulatory agencies.
Review of physical stability data for NDA filing
Goal: Determine if crystal form changes had occurred during stability studies.
Action: Reviewed long term API stability data and compiled a statement for the regulatory filing.
Result: Documentation for NDA filing provided on the results of the physical stability study.
Compilation of solid-state data for patent application
Goal: Determine and compile the requisite solid-state form data to be included in patent.
Action: Reviewed screening, characterization, and crystallization reports to find suitable data for filing; interfaced with characterization laboratory and patent atttorneys to compile relevant data for patent application.
Result: Patent application on multiple solid forms was written and submitted.