Dulaglutide (Trulicity) Manufacturing Plant Project Report 2024

About the Report

The Expert Market Research report, titled “Dulaglutide (Trulicity) Manufacturing Plant Project Report 2024 Edition: Industry Trends, Capital Investment, Price Trends, Manufacturing Process, Raw Materials Requirement, Plant Setup, Operating Cost, and Revenue Statistics,” provides an in-depth and comprehensive examination of the financial and operational aspects of establishing dulaglutide (Trulicity) plant.

The report is the result of extensive primary and secondary research, offering a detailed analysis of current market trends, including the effects of COVID-19 on both global and regional scales. It profiles key industry players, giving insights into their market strategies, production capacities, and financial performance, which are crucial for benchmarking and competitive analysis.

It delves into historical, current, and forecasted price trends, helping stakeholders understand market dynamics and price volatility. The report provides a thorough analysis of the mass balance and raw materials requirements, ensuring a clear understanding of the input-output ratios essential for efficient production. Detailed examinations of the various unit operations integral to the dulaglutide (Trulicity) manufacturing process are included, highlighting process optimisation techniques and technological advancements.

The report presents a comprehensive capital cost analysis, detailing the financial investment required for setting up a dulaglutide (Trulicity) plant. This includes an exhaustive breakdown of costs associated with raw materials, catchem, utilities, labour, packaging, transportation, land acquisition, construction, and machinery. Additionally, it offers an in-depth look at the operating costs, providing clarity on the recurring expenses involved in running the plant.

Projected profit margins and optimal product pricing strategies are outlined, offering guidance on maximising profitability. The report also addresses regulatory frameworks, environmental impacts, and sustainability measures pertinent to the dulaglutide (Trulicity) industry.

About Dulaglutide (Trulicity)

Dulaglutide, sold under the brand name Trulicity, is a medication used to treat type 2 diabetes and reduce the risk of major cardiovascular events in adults with type 2 diabetes. It is a once-weekly injectable glucagon-like peptide-1 (GLP-1) receptor agonist that works by increasing insulin secretion, slowing gastric emptying, and reducing glucagon secretion. Common side effects include nausea, diarrhoea, and decreased appetite. Dulaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 due to the risk of thyroid C-cell tumours.

Properties of Dulaglutide (Trulicity)

Dulaglutide is a clear, colourless, sterile solution. It is produced as a disulfide-linked two-chain molecule (homodimer) in Chinese hamster ovary cells by recombinant DNA technology. The structural formula consists of an N-terminal GLP-1 analogue sequence covalently linked to the Fc portion of a modified human immunoglobulin G4 (IgG4) heavy chain by a small peptide linker.

Each 0.5 mL of Trulicity solution contains 0.75 mg, 1.5 mg, 3 mg, or 4.5 mg of dulaglutide and the following excipients: citric acid anhydrous, mannitol, polysorbate 80, trisodium citrate dihydrate, in water for injection. Dulaglutide has been shown to improve glycaemic control, reduce the risk of major adverse cardiovascular events, and promote weight loss in patients with type 2 diabetes.

Manufacturing Process of Dulaglutide (Trulicity)

The industrial synthesis of dulaglutide (Trulicity) involves recombinant DNA technology to produce the protein in host cells such as E. coli or CHO cells. The gene encoding the dulaglutide protein is synthesized, cloned into an expression vector, and introduced into host cells. These cells are cultured, and protein expression is induced. The cells are then lysed, and the dulaglutide protein is purified through affinity, size exclusion, and ion exchange chromatography. The protein undergoes refolding and oxidation to form the correct disulfide bonds, ensuring proper tertiary structure. Finally, the purified dulaglutide is formulated into a stable pharmaceutical form, sterilised, and filled into pre-filled syringes or pens for subcutaneous administration.

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Synthesis of Dulaglutide (Trulicity)

The synthesis of dulaglutide involves recombinant DNA technology to produce the protein in host cells, followed by purification and formulation processes.

Steps Involved in the Production of Dulaglutide:

1. Gene Cloning and Expression:

• Gene synthesis: The gene encoding the dulaglutide protein is synthesized and optimized for expression in the chosen host cell system (commonly E. coli or CHO cells).

• Cloning: The synthesized gene is cloned into a suitable expression vector.

• Transformation: The recombinant plasmid is introduced into host cells (E. coli or CHO cells) via transformation or transfection.

2. Protein Expression:

• Culturing: The transformed host cells are cultured in a bioreactor under conditions that promote high levels of protein expression.

• Induction: Expression of the dulaglutide protein is induced by adding an inducer (e.g., IPTG for E. coli).

3. Protein Purification:

• Cell Lysis: The cells are harvested and lysed to release the intracellular proteins.

• Initial Purification: The lysate is subjected to centrifugation and filtration to remove cell debris.

• Affinity Chromatography: The clarified lysate is passed through an affinity column that specifically binds the Fc fragment of dulaglutide, allowing for selective purification.

• Size Exclusion Chromatography: Further purification is achieved using size exclusion chromatography to separate the dulaglutide protein based on size and shape.

• Ion Exchange Chromatography: Ion exchange chromatography is used to refine the purity by separating proteins based on their charge.

4. Refolding and Oxidation:

• Refolding: The purified protein is subjected to refolding conditions to ensure proper folding and formation of disulfide bonds.

• Oxidation: The formation of the correct disulfide bonds is promoted by oxidation reactions, ensuring the correct tertiary structure.

5. Formulation:

The purified and correctly folded dulaglutide is formulated into a stable pharmaceutical form, usually involving the addition of stabilizers, preservatives, and excipients. The final product is sterilised and filled into pre-filled syringes or pens for subcutaneous administration.

The production of dulaglutide relies on biotechnological processes, such as:

Formation of Peptide Bonds:

During protein synthesis in the host cells, amino acids are linked by peptide bonds via ribosomal catalysis.

Reaction:

Amino Acid1 + Amino Acid2→ Peptide Bond + H2O

Disulfide Bond Formation:

Oxidation of cysteine residues to form disulfide bonds, critical for the protein's tertiary structure.

Reaction:

2 R-SH → R-S-S-R + 2H+

Structural Formula of Dulaglutide

Dulaglutide is a large protein molecule; its structure includes two identical chains, each composed of a GLP-1 analog linked to an Fc fragment of IgG4. The exact amino acid sequence and disulfide linkages define its functional form.

The process ensures the production of a highly pure and active form of the protein for therapeutic use.

Applications and Drivers of Dulaglutide (Trulicity)

Trulicity was first approved by the FDA in 2014 for treating patients with T2DM, and later gained an expanded indication for reducing major adverse cardiovascular events in adults with T2DM. This expanded use is a major driver of its market growth, as it broadens the patient population that can benefit from the drug. Additionally, dulaglutide's versatility in treatment regimens is another advantage as it can be used alone as monotherapy or in combination with other blood-sugar-lowering drugs if they do not adequately control blood sugar levels. This flexibility increases the market potential for dulaglutide.

The dulaglutide market is expected to grow significantly in the coming years, driven by the increasing global prevalence of T2DM. Moreover, as the manufacturing of dulaglutide expands, distribution and sales of the drug will also grow, propelling the market’s expansion.

Key Features of the Dulaglutide (Trulicity) Production Cost Report:

This production cost analysis report by Expert Market Research scrutinises the dulaglutide (Trulicity) manufacturing process, offering a comprehensive overview necessary for stakeholders considering venturing into this sector. Based on the latest economic data, the report encompasses detailed insights into the primary process flow, raw material requirements, reactions involved, utility costs, operating costs, capital investments, pricing strategies, and profit margins. This report is an indispensable resource for entrepreneurs, investors, researchers, consultants, business strategists, and all those who have any kind of stake in the dulaglutide (Trulicity) industry. It equips them with essential information and strategic insights to effectively navigate the complexities of the market.

The following sections detail the comprehensive scope of the prefeasibility report for a dulaglutide (Trulicity) production plant:

• Market Dynamics and Trends: This section analyses the prevailing market conditions, growth drivers, and trends impacting the dulaglutide (Trulicity) industry. It offers a thorough examination of demand fluctuations and projections.

• Geographic Analysis: Detailed insights into the major regions active in dulaglutide (Trulicity) production and consumption, highlighting regional market specifics and growth potential.

• Key Industry Players: Profiles of leading manufacturers in the dulaglutide (Trulicity) sector, outlining their market share, strategic positions, and operational strengths.

• Price Fluctuations: Analysis of historical, current, and projected price trends, providing stakeholders with essential pricing intelligence.

• Technical Specifications and Process Description: A detailed overview of the dulaglutide (Trulicity) production process including the technology used and innovations within the industry.

• Raw Material Requirements and Sourcing: Evaluation of necessary raw materials, their sourcing strategies, and cost implications.

• Utility Requirements and Costs: Detailed analysis of utilities needed to produce dulaglutide (Trulicity), such as electricity, steam, and process water along with their cost assessments. 

• Labour Force Dynamics: Insights into manpower requirements, including skill specifications and labour cost projections.

• Packaging Needs: Overview of packaging requirements for dulaglutide (Trulicity) to ensure product integrity and cost efficiency.

• Logistics and Transportation: Examination of transportation needs and logistics planning for distribution and supply chain efficiency.

• Capital and Operating Costs: An in-depth look at investment requirements, including land acquisition and its development cost, civil work costs, construction, machinery procurement, and ongoing operational expenses, such as salaries and wages, plant overheads, tax and insurance as well as packaging, transportation, and administration costs.

• Financial Performance and Profitability Analysis: Projected profit margins and return on investment based on current market and operational parameters.

• Product Pricing Strategy: Recommendations on pricing mechanisms based on industry benchmarks and production costs.

• Environmental Impact and Regulatory Compliance: Analysis of environmental considerations and compliance with local and international regulations.

• Risk Assessment and Mitigation Strategies: Identification of potential risks associated with dulaglutide (Trulicity) production and strategies to mitigate them.

Key Questions Addressed:

• What are the detailed unit operations for dulaglutide (Trulicity) production?

• Who are major technology licensors with their process evaluation?

• How are raw materials or catchem procured and what are their cost implications?

• What utilities are essential for production and what will they cost?

• What are the labour requirements and how does this affect operational costs?

• What packaging solutions are optimal for cost and efficiency?

• What logistical arrangements are necessary for efficient product distribution?

• What are the estimated land and construction costs for a new dulaglutide (Trulicity) plant?

• How can profitability be maximised in the dulaglutide (Trulicity) market?

• What pricing strategy should be adopted for dulaglutide (Trulicity) to remain competitive?

This prefeasibility report aims to equip potential investors and existing manufacturers with crucial insights to make informed decisions in the dulaglutide (Trulicity) industry.