Future of Bioprocessing

Future of Bioprocessing

Monoclonal Antibody-Based Therapeutics

Monoclonal antibody-based therapeutics have become increasingly significant in the field of medicine, offering targeted and precise treatments for various diseases. To ensure the success of these therapies, it is crucial to have robust infrastructure and resources in place. Gain more valuable insights into our solutions that aid the development of monoclonal antibodies. Explore cutting-edge analytical technologies, process automation tools, and quality control solutions that contribute to the advancement of this field.

Whether you are a researcher, a pharmaceutical company, or simply interested in understanding the intricacies of monoclonal antibody development, this webpage is your go-to resource. Let's dive into the world of monoclonal antibodies and explore the solutions that pave the way for innovative and effective therapeutics.

 

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The Mission: Driving the Future of Bioprocessing

Monoclonal Antibody Development Workflow

Monoclonal antibody development involves several crucial phases, each playing a vital role in bringing a potential therapy to fruition. It begins with screening and validating target genes, where researchers identify and select specific genes associated with the disease or condition being targeted. This step lays the foundation for subsequent development stages.

The next phase involves cell line development and clone screening. Researchers engineer host cells to produce the desired monoclonal antibodies. This process entails optimizing cell culture conditions, selecting high-producing cell lines, and screening clones to identify those with the most desirable characteristics. We aim to support you every step of the way. Download the infographic to learn more.


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Whitepaper

Automation in Therapeutic Antibody Development

Automation offers a promising solution to challenges during antibodies development by:

  • Accelerating decision-making
  • Enhancing quality control
  • Streamlining development processes

This whitepaper explores the latest progress in mAb development and highlights how automation can expedite the journey from bench to bedside.

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Whitepaper

Recent Trends in Therapeutic Antibodies Development

It's been nearly 50 years since Georges J.F. Köhler and César Milstein pioneered the hybridoma method for producing monoclonal antibodies (mAbs). Since then, there has been a rapid expansion in the field of mAbs and antibody–drug conjugates (ADCs) in development. In this article, we outline trends and challenges in therapeutic antibody development and explore the innovations reducing development timelines and costs.

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Related Content

Evolution History

Process Development

Cell Line Development

Extracellular Vesicles

Learn more with our resources

Application Note

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The Vi-CELL BLU cell viability analyzer: Cell counter performance comparison for CHO and HEK cells

Application Note

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Evaluation of Instrument to Instrument Performance of the Vi-CELL BLU Cell Viability Analyzer

Application Note

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Variability Analysis of the Vi-CELL BLU Cell Viability Analyzer against 3 Automated Cell Counting Devices and the Manual Method

Application Note

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Integration of the Vi-CELL BLU Cell Viability Analyzer into the Sartorius Ambr® 250 High Throughput for automated determination of cell concentration and viability

Application Note

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Cluster Count Analysis and Sample Preparation Considerations for the Vi-CELL BLU Cell Viability Analyzer

 

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References

The Nobel Prize. The Nobel Prize in Physiology or Medicine 2018 – press release. (2018). https://www.nobelprize.org/prizes/medicine/2018/press-release/. 2. The Nobel Prize. The Nobel Prize in Physiology or Medicine 1984 – press release. (1984).
The Nobel Prize. The Nobel Prize in Physiology or Medicine 1984 – press release. (1984). https://www.nobelprize.org/prizes/medicine/1984/press-release/.
Morris ZS, Wooding S, Grant J. The answer is 17 years, what is the question: Understanding time lags in translational research. J R Soc Med. 2011;104(12):510-520. doi:10.1258/JRSM.2011.110180
PhRMA. (2016). Modernizing Drug Discovery, Development and Approval. Accessed February 9, 2024. https://phrma.org/en/resource-center/Topics/Research-and-Development/Modernizing-Drug-Discovery-Development-and-Approval.
Alhazmi HA, Albratty M. Analytical Techniques for the Characterization and Quantification of Monoclonal Antibodies. J Pharm. 2023;16(2). doi:10.3390/PH16020291.
European Medicines Agency. (2023). ICH guideline Q14 on analytical procedure development. Accessed February 12, 2024. https://www.ema.europa.eu/en/ich-q14-analytical-procedure-development-scientific-guideline.
World Health Organization. (2022). Guidelines for the production and quality control of monoclonal antibodies and related products intended for medicinal use. Accessed February 12, 2024. https://www.who.int/publications/m/item/guideline-for-the-safe-production-and-quality-control-of-monoclonal-antibodies.
US Food & Drug Administration. (2023). Current Good Manufacturing Practice (CGMP) Regulations. Accessed February 12, 2024. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations.
European Medicines Agency. Good manufacturing practice. (2023). Accessed February 12, 2024. https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice.
Sifniotis V, Cruz E, Eroglu B, Kayser V. Current Advancements in Addressing Key Challenges of Therapeutic Antibody Design, Manufacture, and Formulation. Antibodies 2019, Vol 8, Page 36. 2019;8(2):36. doi:10.3390/ANTIB8020036.
Wolf B, Piksa M, Beley I, et al. Therapeutic antibody glycosylation impacts antigen recognition and immunogenicity. Immunology. 2022;166(3):380-407. doi:10.1111/IMM.13481.