Generic and complex generic development
For successful commercialization of generic drugs, it is a prerequisite to demonstrate appropriate sameness and bioequivalence to the Reference Listed Drug (RLD). Concept Life Sciences, in partnership with Malvern Panalytical, have significant experience in delivering solutions to support ANDA submissions, deploying specialized analytical techniques and synthetic chemistry expertise across multiple complex dosage forms.
We can support most aspects of Q1/Q2 (qualitative/quantitative equivalence of API and excipients), Q3 (physicochemical determinations to demonstrate the equivalent arrangement of microstructural matter) using an orthogonal array of analytical instrumentation and applications. We also deliver in vitro bioequivalence studies using appropriately validated methods and GMP-qualified instrumentation. Some examples include. MDRS, Spraytec and Next Generation Impactor IVBE studies for pulmonary dosage forms, polymorphic IVBE studies for suspension formulations by XRPD, DSC and FTIR and amorphous content/behavior studies using Isothermal Microcalorimetry.
Furthermore, our expertise in challenging synthetic chemistry is applied to generic development for the structural elucidation and identification of unknown impurities in the drug substance and prototype formulations using techniques such as NMR and semi-preparative mass-directed impurity isolation. Where necessary putative structures can also be synthesized.
We are MHRA and FDA-inspected and routinely develop, validate and transfer methods in support of ANDA submissions and beyond into QC release of drug substance, critical excipients and finished product.
Analytical techniques typically deployed for Q1/Q2/Q3 equivalence studies include:
- DSC, mDSC, TGA
- Isothermal Microcalorimetry (Amorphicity and relaxation studies)
- BET Specific Surface Area
- Helium Pycnometry
- Morphologi 4-ID / Morphologically Directed Raman Spectroscopy
- Particle size / charge
- NGI (Next Generation Impactor)
- Inverse Gas Chromatography
- Size Exclusion Chromatography
- HPLC / uHPLC
- UV, PDA, DAD, Fluorescence
- ELS, RI, CAD, MS, MS/MS
- Inductively Plasma – Optical Emission Spectroscopy / Mass Spectrometry
IVBE (in vitro Bioequivalence) studies to FDA recommendations for a range of dosage forms including:
- Nasal sprays and nebulizers
- Dry powder & metered dose inhalers
- Topical creams & ointments
- Oral solid dose
Identification / structural elucidation of impurities/synthesis of unknown impurities in the API and generic prototypes finished products:
- Preparative Mass-Directed Impurity Isolation
- Analytical method development, verification, validation and transfer
- GMP release testing of Generic API and critical excipients
- We are GMP and GLP accredited; FDA inspected