Generate Actionable Data
Every molecule type requires unique sets of analytical tools; from proof-of-concept for a new molecular entity to long-term safety and efficacy studies post-approval, we will guide you through the process.
Leveraging decades of expertise accelerating small molecule drugs from discovery to the clinic, our team of scientists provide the highest quality development support. Integrating Biology and Chemistry under the same roof, we are able to offer end-to-end solutions across cell-based activity assays, HTS, bioanalyses, analytical characterization, impurity and excipient assessment, formulation development, and more for your small molecule programs.
The challenges of biologics characterization are related to the structural complexity and size of their molecular structure(s). Emery Pharma has the required expertise and state-of-the-art instrumentation to characterize a wide variety of structural and functional attributes for various drug modalities as well as immunogenicity assessment: monoclonal antibodies (mAbs), Fragment-Antigen Binding (Fab) and single chain Fragment-variable region (scFv) proteins, antibody-drug conjugates (ADCs), peptides, oligonucleotides, etc.
Botanicals drugs have been used in traditional medicines for thousands of years. While there is a plethora of benefits to botanicals drugs as a new modality, there are several challenges to this emerging field. Emery Pharma offers a unique blend of experience, instrumentation (LC-MS, NMR, etc.), and expertise (natural products, structure elucidation, etc.) for any botanical drug discovery and development program. We have been highly successful in spearheading multiple botanical drugs from conception, through discovery R&D, IND submission, and clinical trials.
Emery Pharma offers multidisciplinary expertise necessary to guide our Clients’ development for a range of biosimilar drugs. We deliver robust and highly sophisticated analytical methods to compare Biosimilars and Innovator/reference product, as well as assist with pre-clinical (e.g., tolerability, dosing) and clinical (PK/PD assessment) to streamline your Biosimilar projects.
A vaccine is a biological agent that offers acquired immunity against an infectious agent (e.g., virus) or a malignant disease (e.g., cancer). Emery Pharma offers years of experience in vaccine potency analysis (cell-based, β-coronavirus, receptor binding, etc. assays), characterization (HPLC, LC-MS/HRMS, GC, NMR, PAGE, western blots, ELISA, impurity profiling, etc.), stability assessment per ICH guidance, and microbial assays (LAL endotoxin, bioburden, etc.).
Cell & Gene Therapy
Our team of scientists have in-depth knowledge of the current developmental challenges related to cell and gene therapies including regulations from different agencies for adeno-associated-virus (AAV) vectors, adenovirus vectors, or lentivirus vectors. Access solutions for cell/tissue-based assays (isolation, media optimization, modification, purification, and characterization). We are uniquely qualified to navigate analytical characterization challenges around the various surfactants utilized in drug delivery, such as Poloxamers (P-188) and Tween.