At BioPharmaSpec, we understand that the development and manufacture of any biosimilar can be complicated. Our multidisciplinary team has years of experience in characterizing the structural and physicochemical attributes of originators and biosimilars of many different classes of molecule.
We know the hurdles that can be encountered from early development through to multi-batch comparability studies and routine manufacturing. Working with BioPharmaSpec you will feel confident that your development decisions are based on quality data from a trusted CRO partner.
Biosimilar Drug Product Development
BioPharmaSpec scientists have been providing biosimilar comparability testing for decades, so we understand the complex process required to fulfil the regulatory requirements. We offer a comprehensive range of structural, biophysical and physicochemical characterization methods drawing on years of technical expertise and product insight to tailor these to your needs.
- Structural and physicochemical characterization to ICH Q6B
- Comparability studies
- Biosimilarity studies
- Forced degradation studies
- Stability studies
- Product impurity analysis and quantitation, including HCP-MS.
- Process Related Impurities and
- Residual Analysis
An efficient and robust biosimilarity/comparability strategy is crucial for successful development of a biosimilar. BioPharmaSpec provides you with expert reports allowing you to demonstrate structural similarity to the regulators.
Our Approach to Biosimilar Testing
Working with our scientists you get the support you need with every step of your biosimilar development journey:
- Originator product characterization
- Analytical support for clone selection and process development
- Comprehensive physicochemical characterization to demonstrate biosimilarity
- Method development, optimization and routine analysis
- Ongoing consultancy from our scientists to put our structural characterization data into context and support your regulatory package
Biosimilar Testing Capabilities
BioPharmaSpec’s biosimilar testing services allow you to fulfil the global regulatory requirements for biosimilar structural characterization.
Structural
- Primary de novo amino acid sequencing
- N and C terminal sequencing
- Amino Acid Analysis
- Extinction coefficient determination
- Peptide mapping
- Disulfide bridge analysis
- Intact molecular weight
- Monosaccharide analysis
- Oligosaccharide analysis
Physicochemical and Biophysical
- icIEF
- CE-SDS
- Liquid and spectroscopic profiling
- Circular Dichroism
- FTIR
- Intrinsic/ Extrinsic Fluorescence
- µDSC, SLS/DLS
- SEC-MALS, SV-AUC
- 1D and 2D NMR
BioPharmaSpec Biosimilar Experience
Our scientists have a deep understanding of the structure of many different molecule classes and have been involved in hundreds of biosimilar characterization and comparability projects, helping clients accelerate the development of their product.
| Monoclonal Antibodies | Adalimumab, Trastuzumab, Rituximab, Cetuximab, Nivolumab, Pembrolizumab, Infliximab, Bevacizumab, Natalizumab, Ocrelizumab, Vedolizumab, Tocilizumab, Eculizumab, Golimumab, Ustekinumab, Paliviumab and more |
| Antibody Drug Conjugates (ADCs) | Gemtuzumab ozogamicin (Mylotarg), Brentuximab vedotin (Adcetris), and Trastuzumab emtansine (Kadcyla) |
| Fusion Proteins | Aflibercept, Etanercept and Abatacept |
| Fab fragments | Ranibizumab and Certolizumab |
| Hormones | Teriparatide, Parathyroid hormone (PTH), Erythropoietin (EPO), Darbepoetin (DPO), Insulin and insulin analogs, Human Growth Hormone (hGH) and PEG-hGH and more |
| Peptides | Glatiramer acetate, Linaclotide, Liraglutide, Teriparatide, Exenatide, Lanreotide and more |
| Cytokines | Filgrastim and PEG-Filgrastim, Interferons and PEG-Interferons, Interleukins and more |
| Other | Low Molecular Weight Heparins (LMWH) and more |
Need Biosimilar Testing?
There’s no better partner for your project than BioPharmaSpec
BioPharmaSpec scientists provide data to support over biosimilar development programs all over the world. Contact our scientists now with the name of your biosimilar molecule (e.g. Adalimumab, Enbrel, Insulin etc) to receive more information, including quotations for biosimilarity or comparability studies.