The pioneer in complex drug delivery and biopharmaceutical analytical solutions
Biopharmaceutical Analytical Method Development and Validation Services
LLS Health offers the analytical capabilities that form the backbone of any biopharmaceutical development project.
We understand that successful biopharmaceutical development and manufacturing must be supported by comprehensive characterization which is validated according to FDA regulatory guidance. At LLS Health, we employ state-of-the-art techniques to conduct high-throughput sample analysis from R&D through GMP production.
Robust characterization capabilities
We can support the development of both novel biopharmaceuticals and biosimilars. We are also accustomed to dealing with the challenges that biomolecules bring to stability-indicating methodology and in vitro release testing.
A growing number of biopharmaceutical products incorporate both a biological entity and a small molecule. Our knowledge in developing appropriate sample preparation techniques allows for robust characterization of both components of the formulation, in situ and ex situ. Characterizing bio-derived materials or conjugates of biologics and small molecules demands specialized method development and a breadth of expertise.
Our services include assay, purity, and conformational assessment, as well as release testing. Our analytical techniques include:
- Reverse phase HPLC
- Native and denaturing gel electrophoresis with gel imaging capability
- Western blot and slot blot gel separation
- Restriction digest assay
- A260 / A280 UV assay
- UV-Vis or fluorescence plate-based assays
- Standard protein assays
- Kit-based protein assays
- Hybridization assay
Our biologic characterization techniques range from kit-based protein assays to ELISAs and DNA hybridization assays. We have specialized equipment, dedicated biopharmaceutical laboratory space, and a seasoned analytical staff who carry out development and validation of biopharmaceutical methods including peptides, antibodies, and oligonucleotides.
Experienced analytical chemists
Our formulation team employs advanced drug delivery technologies to improve the performance of biologics, including antibody-drug complexes, encapsulation techniques, and LyoCells®. As a result, our analytical services group is well versed in complex method development and validation.
Wide range of characterization techniques
Biopharmaceuticals are unique because their therapeutic efficacy is dependent upon chemical structure, physical structure, and even conjugation or surface modification. Our group knows that a combination of techniques—including size exclusion chromatography (SEC), gel electrophoresis, and solid-state characterization —are needed to comprehensively analyze these products.
LLS Health is a flexible, full-service CDMO, offering formulation development, drug product manufacturing with supporting analytical services and quality oversight as well as professional project management. We can help you every step of the way from concept through commercialization.
We are experienced in developing, optimizing, and implementing stability indicating methods to reliably measure product performance. Our team focuses on delivering robust analytical data that minimizes risk and supports regulatory approvals.
Our development and manufacturing services are complemented by well-designed, ICH-compliant stability programs that accommodate a range of temperature and humidity conditions. We have also invested in a state-of-the-art electronic lab management system that enhances data reporting and statistical analysis.
Our analytical services range from early stage method development through commercial validation. We are expert in complex sample preparation, and our experienced staff will help you design and execute a phase-appropriate analytical strategy.