GMP-compliant Solutions for In Vivo Patient Treatments
Therapeutic antibodies and antigens, many of which are monoclonal antibodies, are traditionally generated from hybridoma screens. Commonly, these are generated from recombination of existing antibodies and then modified to suit the properties needed for treatment, e.g. by using the CRISPR-CAS 9 or similar systems.
Chimeric antibodies, humanized antibodies and complementarity-determining region (CDR) antibodies have an enormous therapeutic use.
Therapeutic antibodies or antibody-fragments are used as carriers for drugs in cancer treatment, where their affinity for high on-target binding ensures desired effects from the therapy provided1. In vaccine development and production, the antibodies and antigens (oligomers) are used for initiating an immune response towards the pathogen in question2.
In production, one of the key pains is having to produce a clinical-grade product for in vivo use directly for patient treatments that is in line with current good manufacturing practices (cGMP).
Therapeutic Antibodies in Patient Treatment
In cancer research, therapeutic antibodies are used mainly to target tumorigenic cells with high specificity and to reduce or eliminate the tumor. They are used for many different types of tumors and are especially effective against tumors that are otherwise difficult to reach and thus target due to their location, size, or lack of cell surface targets, such as neuroblastoma3, or ‘HER2-low’ breast cancer4. A newer approach targets tumor metastasis immunologically, achieved by using therapeutic antibodies to locate and initiate a response to tumorigenic cells before they grow into a tumor5,6.
Therapeutic antibodies are currently used to develop vaccines against SARS-CoV-19 or coronavirus, responsible for the onset of the COVID-19 pandemic in 2019. Besides playing a role in vaccine development, therapeutic antibodies are also used to treat the disease effects of COVID-19, specifically on the respiratory system. Watch this Science Talk to learn how AdaptVac and ExpreS2ion Biotechnologies are generating a SARS-CoV-19 vaccine.
Nanobodies are the recombinant variable domains of heavy-chain-only antibodies. They are useful in disease therapy due to lesion-specific delivery of drugs and effector domains7. Their small size, stability, solubility, penetration ability and quick blood clearance are all parameters that make them translatable to new medical applications in the clinic. This type of personalized medicine, nanomedicine, is gaining interest from the pharmaceutical industry and patient advocates alike.
GMP-Compliant Solutions for Therapeutic Antibody Production
Antibodies and other biologics used for therapeutic purposes must be manufactured in strict GMP conditions to ensure the product is safe and potent for the patient. These exacting conditions give rise to strict requirements on equipment that can be used, as well as data recording and reporting activities. The NucleoCounter® family of instruments are 21 CFR Part 11-ready and can fit seamlessly into any GMP-compliant laboratory.
The NucleoCounter® NC-202™ is robust and reliable—as a result, you will experience minimal downtime, so your work can proceed uninterrupted. To ensure consistent operation, the instrument features built-in protocols for IQ/OQ/PQ. The NucleoCounter® NC-202™ can also streamline data reporting and recording with standardized PDF reports and you have the option to note comments directly onto data files.
The superior technology within the instrument and convenience of the Via2-Cassette™ combined minimizes the variabilities that are normally introduced during pipetting, staining and counting. This method dramatically cuts down on time spent counting cells, which increases the efficiency of your workflow—you will also receive a highly precise result in approximately 30 seconds.
- A Shah, S Rauth, A Aithal, S Kaur, K Ganguly, C Orzechowski, GC Varshney, M Jain, SK Batra: The Current Landscape of Antibody-based Therapies in Solid Malignancies. Theranostics, 2021. 11(3):1493-1512.
- J Majumder, T Minko: Recent Developments on Therapeutic and Diagnostic Approaches for COVID-19. AAPS J, 2021. 23(1):14.
- F Morandi, F Sabatini, M Podestà, I Airoldi: Immunotherapeutic Strategies for Neuroblastoma: Present, Past and Future. Vaccines (Basel), 2021. 13;9(1):43.
- K Riecke, I Witzel: Targeting the Human Epidermal Growth Factor Receptor Family in Breast Cancer beyond HER2. Breast Care (Basel), 2020. 15(6):579-585.
- H Yang, Y-H Kuo, ZI Smith, J Spangler: Targeting cancer metastasis with antibody therapeutics. Wiley Interdiscip Rev Nanomed Nanobiotechnol, 2021. e1698.
- A Rybarczyk-Kasiuchnicz, R Ramlau, K Stencel: Treatment of Brain Metastases of Non-Small Cell Lung Carcinoma. Int J Mol Sci, 2021. 22(2):593.
- Guangfa Bao 1, Ming Tang 1, Jun Zhao 2 3, Xiaohua Zhu 4: Nanobody: a promising toolkit for molecular imaging and disease therapy. EJNMMI Res, 11(1):6.