Discover active drug candidates faster and accelerate time to market with Element's integrated CDMO services platform for comprehensive drug discovery and development services that support the development lifecycle.
Services are tailored to meet your needs, as our manufacturing sites allow for flexible, personal, and cost-effective services (kilo lab). Plus, downstream cGMP manufacturing capabilities have been designed for clinical trials and small-scale commercial APIs. Element’s collaborative, dedicated team of experts has decades of experience successfully solving the most challenging chemical development issues. Our broad range of experience and deep expertise extends through process research and development, scale-up, cGMP production, and commercial manufacturing. So, let's talk about your goals and how Element can help you achieve them.
Target to hit
- Target to hit assay development
- HTS validation
- Fragment screening
- "Smart" HTS utilizing fragment screening technology
Hit to lead
- Proprietary active series development
- Structure activity relationship for two lead series
- Selectivity testing
- Structure-activity relationship for two lead series
- Back-up series
- Cell-based activity testing
- Process and Analytical development
- cGMP kilo lab: Phase I through commercial
- DEA regulated APIs
- Commercial product
- Formulation development
- Analytical method development and validation
- Clinical supplies
Fulfill your NDA requirements and optimize new investigational compounds and non-traditional therapies with Element's microbiology lab services. Answer questions important questions regarding the activity of your compound and achieve development plans with microbiology studies tailored to your needs, incorporating parameters and a vast collection of well-characterized (>500,000) isolates. Connect with us to learn more.
Pre-clinical microbiology services
- Antibacterial/Antifungal spectrum and potency
- Passaging and mutational single-step resistance studies
- MBC and kill-curve methods
- Synergy and drug interaction studies
- Disk development
- Methods development and media effects
- Broth microdilution, agar dilution, disk diffusion, and gradient strip correlations and regression analyses
- Quality control organism range studies
- Special isolate collections
- Bacteriophage assays, including spot testing, culture lysis, and spectrum studies
The Element advantage
We'll help you cut costs and reduce time to market as you develop suitable and stable formulations for various routes of administration. Looking to talk about your drug development, discovery, and clinical trial support needs? Speak with an expert today.
CMC Product Development Services
Find out how our CMC development services support clinical trials and accelerate the overall drug development process for our customers
Pre-Clinical and GMP Clinical Trial Material Manufacturing
Element offers flexible, complete and seamless clinical-scale manufacturing support throughout the entire drug development life cycle, from pre-clinical manufacturing services to phase I and II clinical trial material manufacturing solutions.
Pharmaceutical Pre-Formulation & Formulation Development Services
Element’s pre-formulation and formulation development services help enhance delivery performance and stability of your parenteral, ophthalmic, and topical drug products.
Chemistry, Manufacturing, and Controls (CMC) Consulting Services
We provide consulting services for Chemistry, Manufacturing, and Controls (CMC) product development in the pharmaceutical and biotechnological industries.