Element’s formulation scientists and analytical chemists have decades of experience accelerating the development and optimization of life-changing small and large molecule formulations for parenteral, oral, ophthalmic and topical dosage forms, as well as novel drug delivery systems (NDDS), including those with poor solubility or bioavailability.
From feasibility to formulation development to Chemistry, Manufacturing, and Controls (CMC) strategy and guidance, clinical-stage manufacturing, scale-up and transfer to commercial manufacturing and post-approval support, our team will serve as your scientists, regulatory experts, and consultants. Decades of experience, the capability to tailor protocols and study designs, and a readiness to take on complex and non-routine analyses underpins our all-inclusive, custom-built solutions for new chemical entities (NCE), generics, new molecular entities (NME), new therapeutic biologic products, and biosimilars.
Element’s approach to biopharmaceutical formulation and development is built upon the principles of Quality by Design (QbD), enhancing the performance and stability of complex dosage forms while simultaneously enabling streamlined scale-up activities. Accelerate project timelines and advance the most promising drug and therapeutic candidates through to clinical development with our unmatched technical expertise, one-of-a-kind capabilities, and comprehensive approach that incorporates integrated screening, analysis, and stability assessments of small quantities of drug product at each stage.
Complete pre-formulation support for small and large molecule therapies
Thorough physicochemical characterization of drug substances is essential to achieve an optimal formulation and dosage form design. While challenges are often encountered during drug development lifecycle, failure during a late formulation stage can result in costly delays in drug product development. To avoid these failures and delays, it is important that a preclinical development program is undertaken, as preclinical development programs increase the rate of success as the drug development process progresses. Our highly skilled pharmaceutical scientists and formulators are experts at solving complex challenges early in the drug development process and lifecycle, including developing formulations for compounds with poor solubility, low bioavailability, short half-life, low permeability, gastric intolerability, and poor physical stability.
Element’s biopharmaceutical formulation and development experts can help with API characterization of both small and large molecules, accelerating dosage form development. Our team will develop the proper formulation strategy for you starting with a detailed pre-formulation study, resulting in a strong pre-formulation dosage form design plan that will serve as a platform to accelerate your drug product’s path to the clinic, ensuring unnecessary delays are avoided and an optimized drug product reaches clinics and patients as quickly and safely as possible.
Biopharmaceutical formulation development
As a full-service CDMO, Element has the state-of-the-art equipment, purpose-built facilities, and highly experienced staff to develop optimized, stable formulations for various routes of administration. Our skilled formulation development scientists have extensive experience optimizing formulations and manufacturing processes by conducting design of experiments (DoE), mapping out the design space for optimizing formulation excipients and critical manufacturing process parameters, streamlining scale-up activities to commercial batch manufacturing.
A team of consultative, dedicated, and experienced pharmaceutical scientists will work directly alongside your team to shepherd your biopharmaceutical and therapeutic formulations smoothly throughout the entire drug development process. Our approach is customized at any stage of biopharmaceutical development, whether modifying a formulation or developing a comprehensive development program across your drug product portfolio.
The Element advantage
Large and small molecule-focused clients that range from leading, multinational companies to virtual start-up organizations benefit from Element’s collaborative, client-centric approach. Leverage our extensive expertise in Chemistry, Manufacturing, and Controls (CMC), state-of-the-art equipment, and broad network of scientific and regulatory experts who deliver industry-leading pre-formulation and formulation development services to accelerate the product development life cycle. Our truly flexible services will help you develop the optimal formulation and manufacturing processes for your drug product.
For more information about Element’s pre-formulation and formulation development services or to request a quote, contact us today.
- Raw material sourcing
- Structure characterization
- Solid state analysis
- Salt screening & selection
- Particle size morphology analysis
- Polymorphism studies and polymorph screening
- Thermometric properties (DSC, TGA, HSM)
- Partition and distribution coefficients
- Moisture content
- Solubility profile (intrinsic, equilibrium, kinetic) in various media, pH and solvents
- Excipient selection and compatibility studies
- Stability testing and stability of API via forced degradation (heat, light, oxidative stress, pH)
- Dissociation constants
- Powder flow testing
- Ionization constants
- Intrinsic dissolution of the drug
- Biorelevant solubility and dissolution testing
- Evaluation of supersaturation and precipitation
- Development of analytical methods for release and stability testing of product
- Design specifications and critical quality parameters
- Formulation design and development (compatibility, stability, degradation mechanism elucidation)
- Formulation selection for toxicological and/or clinical studies
- DoE studies, optimization of formulations, and final selection
- Bioavailability enhancement
- Short-term accelerated stability studies for formulation selection
- Continued support for formulations as they undergo standard testing
- Development and validation of methods and specifications
- Packaging evaluation (drug/filter/packaging component compatibility studies)
- Container/closure compatibility, evaluation, and selection studies
- Preservative screening, selection, and testing
- Microbial limits testing
- Antimicrobial effectiveness testing (AET)
- Manufacturing process development and scale-up
- Manufacturing of lab-scale and feasibility batches
- Manufacturing of prototypes and stability testing
- Manufacturing of toxicology and clinical batches
- Technology transfers
- Oral immediate release (tablets, solutions, emulsions, suspensions, and capsules)
- Oral controlled release (matrix-based release, multi-particulate systems, polymer film coatings, and pH dependent release)
- Topicals and transdermals (gels, creams, ointments, suppositories, and lotions)
- Sterile liquid dosage formulations (IV, SC, IP, IM, ophthalmic, and nasal)
- Liquids (solutions, emulsions, colloids, liposomes, and suspensions)
- Novel drug delivery systems (NDDS)
More from Element
Pharmaceutical Method Development and Research Services
Element provides an array of forced degradation and stability studies and assay development services including protocol design, Identification of degradation products and development reports.
CMC Product Development Services
Our CMC product development services include formulation development, parenteral and topical product development, microbiology testing services, and consultancy.
We offer analytical testing of medical and combination devices; ensuring product performance and regulatory compliance.
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.