HCP Products & Services
BioGenes Berlin
The presence of host cell proteins (HCPs) in biologics must be strictly monitored and manufacturing processes need to be optimized to reduce impurities and their risks to a minimum.
At BioGenes, we recognize the importance of reliable and effective monitoring of HCPs and offer a wide range of appropriate products and services for quality control of HCPs during production and for approval of new therapeutics.
The Enzyme-linked immunosorbent assay (ELISA) is still considered the gold standard for HCP measurement, providing high sensitivity, speed, and high throughput. For a profound sample characterization, our team of highly qualified experts utilizes state-of-the-art equipment. This includes two-dimensional methods, such as 2D Electrophoresis, 2D Western Blot and 2D Difference Gel Electrophoresis (2D-DIGE). Moreover, we offer Immunoaffinity Chromatography (IAC) with 2D-DIGE as orthogonal method for HCP coverage determination and optional Mass Spectrometry (MS) for protein identification.
Generic HCP ELISA Kits
When it comes to HCP detection, you may find yourself at a crossroads between generic and customized options. During method development, our common recommendation is to make use of our generic HCP ELISA. It includes a broadly reactive antibody coverage approach, which is specific for only the selected cell line used for recombinant protein expression. Unlike traditional generic HCP assays that rely on a single set of polyclonal antibodies, our enhanced generic 360-HCP ELISA provides multiple kits for CHO, E. coli or HEK cell lines, each using a dedicated set of anti-HCP antibodies. This means you can detect a broader range of HCPs, ensuring a more accurate assessment of impurity levels.
Custom HCP ELISA
The answer to the question: “Which HCP ELISA is best to be used during which phase of development of a drug candidate?” is not an easy one, but we can help!
For late phases of drug manufacturing, all processes need to be validated, including the use of analytical methods. If changes to manufacturing steps are carried out, process validation has to be repeated until a sufficient consistency is reestablished This also includes the monitoring of residual HCP impurities, which can technically vary in amount and composition when changes during manufacturing are implemented. Our customized solutions provide you with the flexibility to address specific HCP profiles and overcome challenges associated with your unique manufacturing processes. We are familiar with the requirements of the regulatory bodies, as many of our HCP ELISAs have been used successfully for both late-stage clinical trials and for drug approvals by the EMA and FDA.
BioGenes has a 25-year proven track record in the development of highly sensitive Host Cell Protein ELISAs. During this time, we have developed more than 400 specific or multi-product/platform HCP ELISAs.
Analytical Methods
Benefit from our scientific knowledge and long-term experience in analytical services and 2D analysis for coverage determination and sample characterization. BioGenes has specialized in two-dimensional sample characterization methods with state-of-the-art equipment and highly qualified staff. Complementing these HCP analytics services with orthogonal mass spectrometry, we can provide reliable HCP monitoring strategies.
Advantages
- Project design and proactive project management in close cooperation with the customer
- In-house development of antibodies (immunization of rabbits, goats, sheep)
- Characterization of antibodies (2D Western blot for HCP coverage determination, performance tests in a preliminary ELISA set-up)
- Development of HCP ELISAs in buffer solution and working matrices
- Qualification/pre-validation of HCP assays according to customers’ requirements and ICH guidelines (ICH Q2B)
- Production of complete ready to use kits or single assay components
- Detailed documentation and reporting
- Technology transfer to the customer – SOPs and training of the staff
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