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Stability and Solubility Studies Chemical and physical stability. The intent of the stability study is to evaluate the chemical and physical stability of the API in solution and solid-state. The solid-state evaluation will probe the pr...
Comprehensive Physicochemical Property Evaluation A comprehensive physicochemical property evaluation is an important premise for the development of formulation and process. It provides an important basis for the druggability evaluation of the compou...
Pediatric Formulation (Mini-tablet) The development of acceptable, palatable pediatric formulations is undergoing transformation within the industry today, driven by patient needs and regulatory requirements. Therefore, the demand for a...
Crystal Formulation Services successfully passed the dual certification of GMP and GDP conducted by SGS Recently, Crystal Formulation Services (CFS) successfully obtained dual certification in Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) from SGS, an internationally recognize...
Development and Production Application Cases of Amorphous Solid Dispersion Formulations (I) - Hot Melt Extrusion Hot-melt extrusion (HME) is recognized as an optimal and efficient technique for manufacturing amorphous solid dispersions, characterized by its continuous processing, increased production efficiency,...
Unveil Key Factors Influencing the Physical Stability of Amorphous Solid Dispersions
Assessment of CQA in mRNA-LNP Modality
Overcoming Bioavailability Barrier to Deliver Protein Degraders Speaker: Dr. Chong-Hui Gu, Head of CMC and QA, Foghorn Therapeutics

Protein degraders offer a new opportunity to address targets that were previously undruggable. However, oral bioavailability issues have limited the use of this modality. This talk will address the factors that limit oral absorption and approaches to overcome those issues. This talk will also overview other delivery options to deliver protein degraders such as long acting injectable formulations.
14th American Drug Delivery and Formulation Summit (Exhibit) Date: 9/16-17 Location: Hyatt Regency La Jolla, San Diego Attendee: Xiaoxia Chen, Ph.D., Chief Technology Officer Chris Heard, BD Director Booth: No.9 Link: https://ddfsummit.com/DDF2024/en/page/home
Developability Assessment, Pre-formulation Study for IND Enabling Strategic designing and generating work package utilizing analytical and biophysical tools to study accelerated and stressed stability of lead candidate for risk assessment
Product Quality Analysis Rationally combined both analytical with various biophysical/chemical tools and bio-analytical with various bioassay tools for structure and structure-function characterization
Additional Capabilities Versatile with flexible adoption of existing methods to address different modalities such as ADC with novel conjugated combinations, mRNA & LNPStrong troubleshooting skills in resolving challengin...
Chiral Separation More than 70% of drug candidates worldwide are chiral. Typically, for chiral API, only one enantiomer or diasteromer is biologically active or desirable. Therefore, the production of enantiopure compounds or diastereomers is imperative. In the production of small molecule drugs with desired chirality, separation via crystallization can be much more economical and environmentally favorable than chromatography.
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Our Partner We continue to provide our clients with high-quality, innovative, customized and technology-driven solutions to move your molecules to the clinic.

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