Polymorph, Salt, Cocrystal, Crystallization Screening and Crystallization Process Development
All the above plus Preformulation, Formulation Technology Assessment, Scale-up and Particle Engineering
At Asha we understand that our clients are often dealing with short timelines. We are experts in using a risk based approach to find the optimal solution to a solid form problem taking into account the time and resources available. Our Chemical Engineering expertise helps us keep scalability of our solid forms and processes in mind even at the screening stage. Our workflows are easily customizable based on the drug molecule and all our work is Phase-Appropriate (based on the drug development timeline).
Asha's workflows combine computer simulations, efficient and highly scientific experimental design and selective automation (the efficiency of automation combined with the scientific judgement of an expertly trained human brain). A particular focus is generating high quality scientific data for smaller companies at a reasonable cost and enhancing the bioavailability of poorly soluble molecules. Please contact us for more details on our workflows (info@AshaSD.com).
We are equally comfortable in both expert and partner roles. We welcome clients who are new to solid form research and need Asha's expertise to guide them through the solid form discovery and selection process. We also welcome clients who have internal experts in the field and want to be involved in the workflow.
We currently offer the following services:
Asha is located in San Diego, California. We are proud to be part of one of the largest and most innovative biotech hubs in the United States.
We are a short drive away for our local clients and a short flight away for our clients in the San Francisco Bay Area. Also, our near perfect year-round weather and spectacular coastline make us a very attractive host for all our clients!
Asha Pharma, LLC
11011 N. Torrey Pines Road
La Jolla, CA 92037
Polymorphs are different crystalline structures of the same chemical compound and often have different physicochemical properties. The FDA's 2007 Guidance on Polymorphism talks about the influence of polymorphism on solubility, dissolution, bioavailability, manufacturing and stability. Polymorph Screening is a critical part of drug development and Asha uses a diverse experimental design and a high number of experiments to help map out the solid form space of a compound.
For ionizable molecules, salt screening can improve the physicochemical or biopharmaceutical (e.g. improved bioavailability) properties of the free form API. Asha uses a diverse experimental design to help discover a high number of viable salts. The approach is divided into two parts: salt formation and crystallization. Also, for API intermediates, Asha's team has experience in using salts to replace expensive chromatography based purification steps with crystallization.
For non-ionizable or weak base/acid APIs, cocrystals can help find suitable development candidates with the desired physicochemical and biopharmaceutical properties. Asha uses a combination of structure-based design and experimental approaches to help discover a high number of viable cocrystals. The FDA's recently finalized (2018) guidance on cocrystals has led to significant interest in this field.
Amorphous materials are difficult to develop and often have issues related to purification, stability and undesired conversion to more stable forms etc. Finding the first crystals of an amorphous material is particularly challenging. Asha's workflows are based on a thorough understanding of the thermodynamic and kinetic phenomena that control crystallization and help optimize the experimental conditions required to crystallize such materials.
We also offer consulting services in the fields of Preformulation, Formulation Technology Assessment, Crystallization Process Development and Scale-up and Particle Engineering. Our team has significant experience in these fields and can help you find the right outsourcing partners, design the right experiments, review data and technical reports and pick the right formulation approach (e.g. free form, salt/cocrystal, micronized API, Spray Dried Dispersion (SDD), Hot Melt Extrusion (HME), lipids etc.).
The following state of the art techniques are used to characterize the samples generated in our workflows: