Indian Institute of Science (IISc), Bengaluru have formulated method for mass-producing recombinant proteins.

Definition of Recombinant Proteins: Recombinant proteins are artificial proteins produced by genetic engineering techniques. The process involves inserting a specific gene (usually from one organism) into a host organism (typically bacteria or yeast), which then expresses the protein.

Importance in Biotechnology: This process is fundamental to genetic engineering and biotechnology. It allows scientists to produce large quantities of specific proteins that may be difficult to obtain from natural sources.

Historical Milestone: The first recombinant protein produced was human insulin, which revolutionized diabetes treatment. This was a major breakthrough in the field of biotechnology and medicine.

Recent Development: The Indian Institute of Science (IISc) in Bengaluru has formulated a method for mass-producing recombinant proteins. This is a significant advancement as it could potentially make the production of these proteins more efficient and cost-effective.

Applications:

 Recombinant proteins have numerous applications in various fields, including:

Medicine: Production of therapeutic proteins, vaccines, and diagnostic tools

Research: Study of protein structure and function

Industry: Production of enzymes for various industrial processes

Agriculture: Development of pest-resistant crops or plants with enhanced nutritional value

Process: The process involves creating new genetic sequences by combining genetic material from different sources. This allows for the production of proteins that may not exist in nature or to produce natural proteins in larger quantities than would be possible through traditional extraction methods.

Advantages:

Allows for large-scale production of specific proteins

Can produce proteins that are difficult or impossible to obtain from natural sources

Enables modification of proteins for enhanced function or stability

Reduces the risk of contamination with unwanted substances that might be present in natural sources

Mechanisms of Recombinant Protein Technology

1. Gene Isolation: This step involves identifying and extracting the specific gene that codes for the desired protein. Techniques used include:

• PCR (Polymerase Chain Reaction) to amplify the gene of interest
• Restriction enzyme digestion to cut out the gene from the source DNA
• cDNA synthesis from mRNA if working with eukaryotic genes

2. Vector Construction: Once isolated, the gene is inserted into a vector, which is typically a plasmid for bacterial hosts or a viral vector for mammalian cells. This process involves:

• Choosing an appropriate vector based on the host organism and expression requirements
• Using restriction enzymes and DNA ligase to cut the vector and insert the gene
• Adding promoter sequences to control gene expression
• Incorporating selectable markers (e.g., antibiotic resistance genes) to identify transformed cells

3. Transformation: The recombinant vector is introduced into host cells. Methods vary depending on the host:

• For bacteria: heat shock or electroporation
• For yeast: lithium acetate-mediated transformation
• For mammalian cells: lipofection, electroporation, or viral transduction

4. Protein Expression: The host cell's machinery is used to produce the recombinant protein. This step involves:

• Optimizing growth conditions (temperature, pH, nutrients) for the host cell
• Inducing protein expression (e.g., using IPTG for lac operon-based systems)
• Monitoring protein production levels
• Addressing issues like protein folding or post-translational modifications

5. Purification: The final step involves extracting and purifying the recombinant protein. This typically includes:

• Cell lysis to release the protein (if not secreted)
• Initial separation using centrifugation or filtration
• Chromatography techniques (e.g., affinity, ion exchange, size exclusion)
• Verifying protein purity using techniques like SDS-PAGE or mass spectrometry

The proposed amendments to the Insolvency Resolution Process for Corporate Debtors under the Insolvency and Bankruptcy Code (IBC) by the Insolvency and Bankruptcy Board of India (IBBI) aim to address several critical areas to improve the efficiency and effectiveness of the Corporate Insolvency Resolution Process (CIRP). Here’s a breakdown of what these amendments might entail and their potential benefits:

Key Objectives of the Amendments

1. Enhanced Efficiency:
   • Streamlined Procedures: Simplification of procedural requirements to speed up the resolution process and reduce delays.
   • Clarification of Roles: More defined roles and responsibilities for various stakeholders, including the Insolvency Professional (IP) and the Committee of Creditors (CoC), to minimize disputes and ambiguity.
2. Cost Reduction:
   • Lower Administrative Costs: Changes aimed at reducing the costs associated with the CIRP, making it more cost-effective for corporate debtors and creditors.
   • Optimized Resource Utilization: Better allocation and use of resources throughout the resolution process.
3. Increased Transparency:
   • Enhanced Disclosure Requirements: Greater transparency in disclosures by corporate debtors, IPs, and other stakeholders to ensure all relevant information is available to creditors.
   • Improved Reporting Mechanisms: Better mechanisms for reporting progress and decisions during the CIRP to all relevant parties.
4. Benefits to Creditors and Stakeholders:
   • Fairer Outcomes: More equitable treatment of creditors, including provisions to protect their interests and ensure they have a say in the resolution process.
   • Informed Decision-Making: Access to comprehensive and timely information to make well-informed decisions regarding the resolution plan.

Potential Changes in Regulations

• Revised Timelines: Adjustments to the timelines for various stages of the CIRP to ensure quicker resolution without compromising due process.
• Insolvency Professional Fees: Guidelines for more transparent and reasonable fees for insolvency professionals.
• Resolution Plan Approval: Updated criteria and procedures for the approval of resolution plans to balance efficiency with thorough scrutiny.
• Legal and Procedural Clarifications: Amendments to clarify legal ambiguities and procedural issues that have emerged during the implementation of the IBC.

Expected Impact

• For Corporate Debtors: The amendments should make the CIRP more manageable and less burdensome, potentially increasing the chances of successful resolution.
• For Creditors: Improved processes and transparency will likely enhance their ability to recover dues and participate effectively in the resolution process.
• For the Economy: A more efficient CIRP could improve overall business confidence and contribute to a healthier economic environment by enabling faster resolution of insolvencies.

About IBC

The Insolvency and Bankruptcy Code (IBC) in India provides a structured process for addressing insolvency issues of corporate debtors.

Process Followed Under the IBC

1. Default and Application for CIRP:
   • When a corporate debtor (CD) defaults on loan repayments, either the creditor or the debtor can apply for the initiation of the Corporate Insolvency Resolution Process (CIRP).
   • Previously, the minimum default amount to initiate insolvency was ₹1 lakh. However, to provide relief amid the pandemic, the government raised this threshold to ₹1 crore.
2. Adjudicating Authority (AA):
   • Applications are filed with the National Company Law Tribunal (NCLT), which serves as the designated adjudicating authority (AA) under the IBC.
   • The NCLT has 14 days to either admit or reject the application, or it must provide reasons if the admission is delayed.
3. Initiation of CIRP:
   • Once the NCLT admits the application, the CIRP or resolution process begins.
   • The CIRP must be completed within a mandatory deadline of 330 days, including any extensions.

Recent Proposals by IBBI

1. Comprehensive Valuation Report:
   • The IBBI proposed that registered valuers submit a comprehensive valuation report for the entire corporate debtor, rather than separate valuations for different asset classes.
   • For companies with assets up to ₹1,000 crore and MSMEs, the board suggests appointing one registered valuer for fair value and liquidation value estimates. However, in complex cases, two valuers may be appointed.
2. Interim Resolution Professional:
   • To avoid delays in appointing authorized representatives (ARs) for creditors, the IBBI proposed allowing the interim resolution professional to handle certain functions during the CIRP.
3. Release of Guarantees:
   • The resolution plan submitted by the applicant will not extinguish creditors' rights to pursue guarantors and enforce guarantees as per existing agreements.

Significance of the Proposals

• Eliminating Inconsistencies: The proposals aim to align the CIRP regulations with the Companies (Registered Valuers and Valuation) Rules, reducing inconsistencies.
• Reducing Costs and Expediting Process: These measures are designed to cut CIRP costs and speed up the resolution process, especially for small entities, enhancing overall efficiency.