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 for parenteral, semi-solid and solid dosage forms, including sterile fill-finish and aseptic manufacturing services.
As part of our integrated product development and formulation service offerings, our pre-clinical and clinical-stage manufacturing support solutions have been designed for flexibility, responsiveness and speed to meet the unique needs of your drug or therapeutic, delivering the safest, most efficacious product on your timeline. With wrap-around services including discovery, active pharmaceutical ingredient (API) development and manufacturing, characterization of raw materials, formulation development, comprehensive CMC support including analytical testing, method development and validation, pre-clinical supply and small-batch manufacturing, GMP batch manufacturing and release, cleaning validation, and stability storage and testing, Element is the trusted CDMO partner for leading biopharmaceutical organizations. Our consultative, highly trained, and knowledgeable team of regulatory and scientific experts can help you move quickly and efficiently from preclinical testing into clinical development and clinical-stage manufacturing.
Pre-clinical supply services
- Improved route and starting material research services
- Route scouting
- Active pharmaceutical ingredient (API) development
- API manufacturing
- Process development (mg to kg scale)
- R&D, engineering batch, and GLP manufacturing
- Drug candidate manufacturing and production
- Isolation and identification of impurities
- Scale-up and technology transfer
Clinical trial material (CTM) supply services
- Placebo development
- Clinical trial batch manufacturing
- Packaging and labeling
- Stability storage
- Scale-up and technology transfer
Manufacturing specialization & CTM production processes
- Sterile fill-finish and aseptic manufacturing
- Blending/homogenization
- Filtration, granulation, compacting, mixing, and filling
- Hot melt extrusion
- Milling
- Spray drying
- Pellet (bead) and powder encapsulation
- Powder blending and tableting
- Liquid, cream, and suppository manufacturing
- Container/closure selection
- Scale-up and technology transfer
The Element advantage
From pre-clinical supply services designed to optimize processes suitable for scale-up in later development stages to complete phase I and II clinical-stage manufacturing and wrap-around support, Element’s teams of scientific and regulatory experts can help you accelerate time to clinic. In addition to offering packaging and labeling on products manufactured on your behalf, over-encapsulation can be performed to formulate and manufacture matching placebos for comparative studies.
With a proven track record of solving the complex problems that can arise during the formulation and development process, and our full-service biopharmaceutical development laboratory can support you in all stages of small and large molecule drug development. To learn more about our pre-clinical supply and clinical trial material manufacturing services, or to speak with one of our experts, contact us today.
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Aseptic Manufacturing & Sterile Fill-Finish
Element offers comprehensive sterile fill-finish solutions tailor-made to support clinical studies, compounding pharmacies and small-scale batches, including small bulk fills.
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.
CMC Product Development Services
Our CMC product development services include formulation development, parenteral and topical product development, microbiology testing services, and consultancy.
Pharmaceutical Stability Storage and Testing
Element offers advanced pharmaceutical stability testing and ICH storage services to ensure the maintenance of product quality, safety and efficiency throughout the shelf life.