Analytical method development and validation services supported by experienced analytical scientists and state-of-the-art equipment are integral to any drug development program. At Lysis Pharma, we provide thorough analytical support, candidate screening, drug product analytical services and phase-appropriate method development and validation for drug substances, particle-engineered intermediates, and drug products. Our drug substance analytical services are tailored to your specific program and timelines range from development of early-stage compound handling protocols to optimization of Quality Control methods during late stage development.
Based on the experience of developing thousands of small molecules and a track record in cGMP compliance, we are well positioned to partner with you on all analytical method development aspects of your API.
What to Expect
Our launch and large-scale API commercial production facilities provide flexible capabilities in meeting your commercial API requirements:
- Contained environments (isolation, solids handling) Low-temperature modules Solvent recovery plants Reactor volumes from 160-16000L Low (-90C) to high (650C) temperature reactions High pressure reactions (80 atm) Back-integrated (diketene, ketene, HCN, acetylene) Back-integrated (diketene, ketene, HCN, acetylene)
We understand your analytical objectives throughout the drug development process and work with you to ensure that appropriate methodologies are available at all stages, e.g.
Early handling protocols for your compound Analytical methods to support your early formulation prototype characterization including assay, purity and dissolution Phase-appropriate methods to support batch release and stability testing of early phase compound, intermediate or drug product manufacturing Method optimization to ensure robustness Finalization of analytical methods to support your Phase III, registration and commercial drug substance or drug product manufacturing to cGMP guidelines.
End-to-End API Analytical Services
We also provide full analytical method testing from preclinical development through late stage clinical and commercial production of drug product compounds, intermediates and finished drug products, e.g.
Preclinical prototype evaluations Excipient compatibility studies Finished product testing including purity, dissolution and physical characterization Full range of ICH stability studies (storage and testing) Our experienced teams of API analysts and our extensive Good Laboratory Practice (GLP)-compliant facilities throughout the globe provide support for development of early formulations, clinical-trial materials, and commercial products. Once validated, analytical methods are routinely used for release of the products in our quality control laboratories. For optimum responsiveness, we have located state-of-the-art analytical method-development laboratories at each of our integrated product-development sites, providing rapid analytical services to fit your development timelines.
Know our Analytical Services
API Clinical Trial Material Manufacturing Services Integrated API clinical trial material development and manufacturing services
Our extensive network of state-of-the-art lab and small-scale synthesis plants are fully equipped to exclusively develop and manufacture API for early and late stage clinical trials.
We produce clinical trial materials for complex APIs and intermediates requiring multi-step synthetic processes from milligrams to tons, supporting clinical trials from pre-clinical through to Phase III and launch.
API CTM Resources
Our project managers and chemical development service teams – comprised of small molecule product development, manufacturing support and analytical services – work collaboratively with customers to ensure that phase-appropriate clinical trial material requirements are met for drug programs. We have more than 140 scientists (PhD, MSc and BSc level qualifications) supporting all aspects of drug substance development and clinical trial material manufacture for APIs
Our R&D and kilo labs support process development, sample preparation for drug substances and intermediates for early stage clinical trials. Small scale and mid-scale plants are also in place which support early and later phase clinical trial material production, as well as low-volume commercial quantities to batch quantities up to 150kg.
Multiple reactors are in place to support an extensive range of chemical synthesis technologies including organometallic reactions, oxidations, reductions, highly reactive and hazardous chemicals, asymmetric reactions and reactions under special conditions.
Particle engineering capabilities at lab and pilot scale are also available for particle size reduction and spray dry processing of drug substances as required to meet desired API characteristics and target drug product profiles.
Flexible API clinical trial material development and cGMP assets to support your chemical synthesis from concept to commercial
As part of our comprehensive product development for drug substances and intermediates, we provide phase-appropriate clinical trial material for feasibility studies, early and late phase clinical trials. In addition to R&D and kilo-Lab capabilities, we have dedicated small-scale and launch-scale facilities to support early stage and late-stage clinical trial programs, respectively.
Specialized HPAPI R&D labs and small scale plants support early phase clinical to low volume commercial production of potent compounds (to OEL ≥ 1ng/m3) and ADC payloads.
Clinical Trial Material Labeling and Quality Requirements
Our R&D pilot plants and small scale plants adhere to strict global quality standards and facilitate seamless technical transfer into our launch and commercial scale facilities. Our QA and regulatory services team provide all data, information and support required for the CMC portion of regulatory findings.
Work With Best Team
Round Rock, TX 786810
Monday – Friday
8.00am – 8.00pm
10.00am – 4.00pm
10.00am – 4.00pm