Dr. Neelanjan Bose, the Chief Scientific Officer at Emery Pharma, offered an overview of botanical drug development in his presentation. Botanical drugs are defined by the FDA as products derived from plants, fungi, algae, and plant materials. Unlike traditional natural product-based pharmaceuticals, such as Vancomycin or Taxol, botanical drugs are complex mixtures and require a distinct development approach. They offer benefits such as multifactorial activity profiles and established safety profiles from historical use. Holding significant intellectual property and exclusivity for a botanical drug is more attainable due to the complexity of the drug substance.
Developing botanical drugs comes with unique challenges. Conventional analytical tools may not be suitable for analyzing complex mixtures, and alternative techniques like high-resolution mass spectrometry and NMR are recommended. Batch-to-batch variability is inevitable due to natural variation in geographic and climatic conditions, and must be monitored adequately. Understanding the mode of action and identifying active ingredients in botanical drugs is challenging but important. Formulation and stability testing require working with experienced scientists and using non-traditional analytical techniques.
Emery Pharma has extensive experience with botanical drugs and welcomes inquiries for questions, concerns, or potential partnerships.
About Emery Pharma:
Emery Pharma is a full-service contract research laboratory, supporting the end-to-end development of small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more.
Emery Pharma's premium services include analytical, bioanalytical solutions, microbiology & cell biology services, drug and impurity characterization, and general R&D and cGMP/GLP support.
At Emery Pharma, our focus is to find innovative solutions for our Clients’ toughest challenges and tailoring those solutions to fit each Client’s unique needs. Our experienced scientific team will manage the process: from drug discovery, proof-of-concept, data management, data analysis, to gathering insights. The team excels at solving scientific challenges, and addressing any issues early in the process, so Clients don’t experience unnecessary setbacks.
Emery Pharma’s experienced chemists and biologists deploy state-of-the-art technology. Instrumentation ranges from high-resolution mass spec (Orbitrap), Triple quad LC-MS/MS, GC-MS, Preparative HPLC, and 400 MHz multinuclear NMR.
Contact us: info@emerypharma.com
emerypharma.com/
keywords associated with this presentation:
Botanical drugs
FDA guidance
Regulatory framework
Herbal medicine
Natural products
Medicinal plants
Drug discovery
Pharmacognosy
Therapeutic potential
Safety and efficacy
Clinical trials
Standardization
Quality control
Formulation
Intellectual property
Pharmacokinetics
Pharmacodynamics
Bioactive compounds
Drug metabolism
Biotechnology in botanicals.
background music:
Upbeat Corporate by JP Bianchini jpbianchini.com Creative Commons - Attribution 3.0 Unported - CC BY 3.0 Free Download / Stream: bit.ly/upbeat-corporate Music promoted by Audio Library • Upbeat Corporate