Artificial Polyclonal Immunoglobulin via Recombinant ScFv Mixture
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Solution Overview
Problem
Current artificial monoclonal immunoglobulin preparations lack stability in properties and therapeutic effect due to their monoclonal nature, and there is a risk of infection from blood-derived materials, along with supply instability.
Innovation Solution
A recombinant DNA technology-based method to produce a polyclonal immunoglobulin composition using a mixture of single chain variable fragments (ScFvs) comprising heavy chain variable regions, heavy chain constant region 1, and hinge regions, which are different from each other, derived from cDNAs of immunoglobulin-expressing tissues or cells.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If blood preparation is used to obtain immunoglobulin, then therapeutic effect is achieved, but infection risk increases
Solution Approach 1:
The patent extracts and isolates specific immunoglobulin genes from blood preparations, separating the useful therapeutic component from the harmful contaminants. By identifying and extracting only the immunoglobulin coding sequences while excluding viral and bacterial contaminants, the invention creates a safe artificial immunoglobulin preparation that maintains therapeutic efficacy without infection risk.
Solution Approach 2:
The patent creates artificial copies of immunoglobulin genes through recombinant DNA technology. By synthesizing and cloning immunoglobulin cDNA into expression vectors, then producing the proteins in host cells, the invention creates artificial copies that replicate the therapeutic function of blood-derived immunoglobulins without containing any harmful pathogens present in the original blood source.
2Ease of manufacture
If monoclonal immunoglobulin is produced, then manufacturing simplicity is improved, but therapeutic efficacy decreases
Solution Approach 1:
The patent merges multiple monoclonal immunoglobulin lines into a single polyclonal preparation by combining the secretions from different cloned cell lines. This merging process restores the polyfunctional therapeutic efficacy needed for treating various infectious and inflammatory diseases, while maintaining the manufacturing advantages of recombinant DNA technology.
Solution Approach 2:
The patent creates a universal artificial immunoglobulin preparation that can treat multiple disease types (infectious diseases, inflammatory diseases, vasculitis) through its polyclonal nature. The preparation contains multiple immunoglobulin subclasses and specificities that collectively provide broad-spectrum therapeutic activity, making it applicable to diverse clinical conditions.
3Reliability
If blood-derived immunoglobulin is used, then immediate therapeutic effect is achieved, but supply stability deteriorates
Solution Approach 1:
The patent performs preliminary actions by pre-characterizing and pre-validating the immunoglobulin genes in controlled laboratory conditions before production. The expression vectors and host cell lines are pre-optimized, and the manufacturing process is pre-standardized, enabling consistent, stable supply of artificial immunoglobulin that can be produced on-demand without relying on variable blood donation sources.
Data Source
AI summary
The present invention intended to provide an artificial polyclonal immunoglobulin composition having a high therapeutic effect and high safety, and being capable of stable supply in a large amount. Specifically provided is an artificial polyclonal immunoglobulin composition containing, as active ingredients, 204 polypeptides represented by amino acid sequences set forth in SEQ ID NOS: 1 to 204 of the sequence listing, the polypeptides being plural kinds of single chain variable fragments (also referred to as ScFvs) each comprised of a heavy chain variable region, heavy chain constant region 1, and hinge region (VH-CH1-hinge) of an immunoglobulin, in which the heavy chain variable regions are different each other.