Bulk Pharmaceutical API Sources for OPTISON

Bulk Pharmaceutical API Sources for OPTISON

Vendor	Vendor Homepage	Vendor Sku	API Url
Amadis Chemical		A838638
AKos Consulting & Solutions		AKOS006228213
TimTec		SBB090673

Bulk Active Pharmaceutical Ingredient (API) Sources for: OPTISON

Last updated: July 29, 2025

Introduction

Optison, a diagnostic agent used in echocardiography, prominently features albumin as its active pharmaceutical ingredient. This perflutren-based contrast agent enhances ultrasound imaging of the heart's chambers and wall motion. Unlike many pharmaceuticals with complex synthetic APIs, Optison’s API—human serum albumin—derives from biological sources, making the sourcing of the API a critical factor in manufacturing, regulatory compliance, and cost management.

This article explores bulk sources for the active pharmaceutical ingredient of Optison, focusing on human serum albumin procurement pathways, manufacturing considerations, quality standards, and key suppliers. Understanding these sources enables manufacturers and stakeholders to optimize supply chains, ensure product safety, and maintain regulatory compliance.

Understanding the Active Pharmaceutical Ingredient of Optison

Optison’s active component is human serum albumin (HSA), a plasma-derived protein that stabilizes microbubbles used as contrast agents. The API’s purity, safety, and consistency significantly influence the efficacy and regulatory approval of the final product.

Human Serum Albumin (HSA):
HSA is a 66.5 kDa protein constituting about 50% of plasma protein. It is primarily sourced from pooled human plasma, subjected to rigorous purification and viral inactivation processes to meet pharmacopeial standards (such as USP and European Pharmacopoeia).

Primary Sources of HSA for Pharmaceutical Use

1. Human Plasma Collection and Fractionation

Most pharmaceutical-grade HSA originates from human plasma donations collected globally. Large-scale plasmapheresis centers supply plasma, which is then processed through fractionation techniques like Cohn cold ethanol fractionation to isolate albumin.

Advantages:

• Availability of large plasma volumes.
• Well-established manufacturing processes.

Challenges:

• Ensuring safety and pathogen inactivation.
• Regulatory scrutiny over donor screening and plasma sourcing.

2. Certified Blood Banks and Plasma Collection Centers

National and regional blood banks serve as primary plasma sources. They follow strict donor screening, testing for HIV, HBV, HCV, and other pathogens, complying with Good Manufacturing Practices (GMP).

Key considerations:

• Traceability of plasma donors.
• Compliance with regulatory standards, including FDA, EMA, and WHO.

3. Commercial Plasma Suppliers and Fractionation Companies

Leading pharmaceutical companies and plasma fractionators supply bulk plasma raw material. These entities often operate under licensed, GMP-compliant facilities with comprehensive pathogen reduction steps.

Notable Suppliers:

• CSL Behring: A leading provider of plasma-derived products, including albumin, with over 100 years of experience in plasma fractionation.
• Grifols: Operates multiple fractionation plants and offers pharmaceutical-grade albumin globally.
• Takeda Pharmaceuticals (former LFB Group): Supplies plasma-based products with stringent quality control measures.
• Biotest: Supplies plasma-derived proteins, including albumin, with certified GMP facilities.

4. Recombinant and Alternative Sources

Currently, recombinant human serum albumin (rHSA) is under development but has not achieved widespread commercial use for products like Optison due to cost and regulatory hurdles. The predominance of plasma-derived albumin persists because of its established safety record and proven efficacy.

Regulatory and Quality Considerations

1. Regulatory Standards:
API suppliers must adhere to internationally recognized standards such as USP, EP, and JP pharmacopeias. The HSA must undergo viral inactivation/removal steps, including pasteurization, solvent/detergent treatment, or nanofiltration.

2. Stringent Testing and Documentation:
Includes testing for proteins, endotoxins, residual viruses, and prions. Certificates of Analysis (COA) and compliance documentation are vital for approval.

3. Traceability and Supply Chain Security:
Due to the biological nature, supply chains must ensure traceability from plasma donors to final purification, minimizing contamination risks and ensuring regulatory compliance.

Global Distribution and Key Suppliers

Supplier	Location	Capabilities	Certification
CSL Behring	Australia/USA	Large-scale plasma fractionation, viral safety, GMP compliance	FDA, EMA, TGA certifications
Grifols	Spain/Worldwide	Extensive plasma collection, advanced purification techniques	ISO 9001, WHO cGMP, FDA approvals
Takeda (LFB)	France	Specialized plasma fractionation, rigorous viral elimination processes	European and US regulatory compliance
Biotest	Germany	High-quality plasma fractionation with extensive quality controls	GMP, ISO standards

Manufacturing and Supply Chain Challenges

• Supply Dependency: Heavy reliance on plasma donations can lead to supply shortages or variability.

• Pathogen Safety: Ensuring viral inactivation/removal remains a critical component of manufacturing.

• Cost Implications: Plasma-derived albumin is resource-intensive to produce, impacting pricing strategies.

• Regulatory Dynamics: Variability in international regulatory requirements influences sourcing and quality standards.

Emerging Trends and Alternatives

While plasma-derived HSA remains dominant, emerging recombinant technologies aim to eliminate dependence on human donors. Recombinant human serum albumin offers advantages such as consistent supply, reduced pathogen risk, and potentially lower costs. However, regulatory approval processes are still underway, and adoption in contrast agents like Optison remains limited.

Conclusion

The primary bulk sources of API for Optison are plasma-derived human serum albumin obtained from reputable, GMP-certified fractionation companies like CSL Behring and Grifols. These suppliers operate under strict regulatory oversight, ensuring the safety, efficacy, and quality of the API. While technological advancements in recombinant protein production are promising, plasma-derived albumin remains the standard active ingredient for contrast agents like Optison due to established safety profiles and existing manufacturing infrastructure.

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Key Takeaways

• Human serum albumin is the active pharmaceutical ingredient for Optison, primarily sourced from plasma via large-scale fractionation.
• Reputable suppliers include CSL Behring, Grifols, Takeda, and Biotest, all adhering to stringent GMP and regulatory standards.
• Ensuring viral safety, traceability, and compliance is critical in sourcing HSA for pharmaceutical applications.
• The future may see increased adoption of recombinant albumin, but plasma-derived sources dominate currently.
• Strategic procurement and supply chain management are essential to maintain consistent API supply for Optison manufacturing.

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FAQs

1. What are the main considerations when sourcing albumin for Optison?
Ensuring high purity, viral safety, regulatory compliance, traceability, and cost-effectiveness are critical. Suppliers must provide comprehensive documentation, including Certificates of Analysis and viral inactivation protocols.

2. Are recombinant human serum albumin sources viable replacements for plasma-derived albumin in Optison?
Recombinant albumin offers benefits like consistent supply and reduced pathogen risk, but regulatory approval and cost factors are ongoing challenges. Currently, plasma-derived albumin remains standard in contrast agents.

3. How do manufacturers ensure viral safety in bulk albumin supply?
Through validated viral inactivation/removal steps such as pasteurization, solvent/detergent treatment, nanofiltration, and robust testing, including NAT (Nucleic Acid Testing).

4. Which regions are leading in plasma collection for albumin production?
Regions with established blood and plasma donation infrastructure, including North America (US and Canada), Europe, and Australia, dominate plasma collection for pharmaceutical-grade albumin.

5. How do geopolitical factors influence the sourcing of bulk albumin?
Geopolitical issues can impact supply chain stability, regulatory harmonization, and transportation logistics, necessitating diversified sourcing strategies and partnership with multiple suppliers.

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References

[1] FDA. “Human Serum Albumin (HSA) - Drug Safety Communication”. U.S. Food and Drug Administration, 2012.
[2] European Pharmacopoeia. “Albumin, Human”. European Directorate for the Quality of Medicines & HealthCare, 10th Edition.
[3] CSL Behring. “Plasma-derived Proteins”. CSL Behring Corporate website.
[4] Grifols. “Plasma Proteins Production”. Grifols Global Website.
[5] Takeda Pharmaceuticals. “LFB Group Overview”. Takeda Annual Reports.