Bulk Pharmaceutical API Sources for albumin human

Bulk Pharmaceutical API Sources for albumin human

Vendor	Vendor Homepage	Vendor Sku	API Url
ChemExper Chemical Directory		HmT@D@dDdLdJdFdAdIdEdLbdLadjjj`@@
NovoSeek		6432
ABI Chem		AC1L1MIR
ABI Chem		AC1Q4IBX
ISpharm		I14-14876
ChemMol		49416688

Bulk Active Pharmaceutical Ingredient (API) Sources for: Albumin Human

Last updated: July 30, 2025

Introduction

Human serum albumin (HSA) is a plasma protein with vital therapeutic applications, predominantly in volume expansion and stabilization of plasma colloid osmotic pressure. It is also used as a drug carrier and in various medical diagnostic treatments. As a high-demand biopharmaceutical, sourcing quality-assured, compliant bulk API for human albumin is critical for pharmaceutical companies and bioscience manufacturers aiming to meet regulatory standards and market needs.

This article provides an authoritative overview of global sources for bulk human albumin API, analyzing key suppliers, manufacturing processes, regulatory considerations, and future trends. It aims to assist industry stakeholders in identifying reliable sourcing options aligned with quality, compliance, and logistical requirements.

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Global Suppliers of Human Albumin API

The procurement of human albumin API revolves around a limited – yet specialized – group of manufacturers. Key suppliers predominantly operate within the United States, Europe, and Asia, where comprehensive bioprocessing infrastructure and regulatory oversight ensure product safety and efficacy.

1. Grifols (Spain)

• Overview: Grifols, a leading plasma-derived products manufacturer, is one of the pioneers in human albumin production. Its plasma fractionation facility in Barcelona leverages advanced fractionation and purification technologies.
• API Details: Grifols produces pharmaceutical-grade human albumin, complying with European EMA and U.S. FDA regulations. Their high purity, low anti-complement activity, and rigorous pathogen inactivation processes meet international standards.
• Regulatory Standing: Their products are widely accepted globally, with multiple approved indications, including volume replacement and albumin-based therapies.
• Supply Modes: Commercial-scale bulk API is available for both fully licensed products and bulk procurement for further formulation.

2. CSL Behring (Germany / USA)

• Overview: CSL Behring is renowned for its plasma-derived therapies, including albumin. The company operates state-of-the-art fractionation facilities with robust pathogen safety measures.
• API Details: The company offers pharmaceutical-grade human albumin manufactured via cryoprecipitation and chromatographic purification, ensuring high purity standards.
• Regulatory Standing: Approved by major agencies, CSL Behring’s bulk APIs are used worldwide, supporting critical clinical and therapeutic applications.
• Supply Modes: They offer bulk API primarily to licensed pharmaceutical manufacturers for formulation and distribution.

3. Octapharma (Switzerland)

• Overview: Octapharma specializes in plasma-derived products, including human albumin, with manufacturing facilities across Europe and the Americas.
• API Details: They utilize proprietary fractionation processes combined with viral clearance technology, maintaining stringent quality controls.
• Regulatory Standing: Their products are approved in multiple jurisdictions, including the U.S. and Europe, emphasizing safety and efficacy.
• Supply Modes: Bulk API sourcing options are available for pharmaceutical partners.

4. Shandong Taibang Biological Products Co., Ltd. (China)

• Overview: As a significant Chinese biopharmaceutical player, Shandong Taibang produces plasma-derived products, including human albumin.
• API Details: Their albumin is produced via controlled plasma fractionation, complying with Chinese national standards (e.g., API standards for plasma products).
• Regulatory Standing: Their products have CFDA (now NMPA) approval for domestic use and are increasingly expanding distribution globally.
• Supply Modes: Offers bulk API primarily for the domestic market, with growing export capabilities.

5. Haemonetics (United States)

• Overview: While primarily a blood and plasma collection technology provider, Haemonetics supports plasma protein production, including sourcing raw materials for albumin.
• API Details: Their focus is on plasma collection systems; collaboration with plasma fractionators may facilitate access to bulk albumin API.
• Regulatory Standing: Partners with licensed manufacturers adhering to cGMP and international standards.

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Manufacturing Processes and Quality Considerations

The integrity of human albumin API hinges on meticulous manufacturing processes, ensuring safety, purity, and biological activity. The primary production methods are:

• Plasma Fractionation: The traditional Cohn process involves cold ethanol precipitation, followed by chromatographic purification and viral inactivation steps such as pasteurization or solvent/detergent treatment.
• Recombinant Technology: Although recombinant albumin exists, it is primarily used for research; recombinant human albumin (rHSA) is emerging but has yet to outperform plasma-derived in terms of commercial bulk supply.

Key Quality & Safety Aspects

• Pathogen Reduction: Viral inactivation processes (e.g., solvent/detergent, pasteurization) are critical given the plasma origin.
• Purity Standards: US Pharmacopeia (USP), European Pharmacopoeia (EP), and WHO standards govern acceptable residual impurities, endotoxin levels, and protein activity.
• Regulatory Compliance: Suppliers must comply with cGMP standards, with certification from regulatory agencies like FDA, EMA, and NMPA.
• Traceability & Sourcing: Due diligence on plasma source origin and donor screening is vital to mitigate risks associated with transmissible diseases.

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Regulatory and Logistical Challenges

The sourcing of human albumin API entails navigating complex regulatory landscapes due to the plasma origin and potential safety concerns. Manufacturers must ensure documentation on plasma donor screening, viral safety measures, and manufacturing validation.

Logistical considerations include supply chain stability, storage conditions, and export restrictions. As plasma products are sensitive biologics, cold chain logistics are generally mandated, with advanced quality controls to prevent contamination or degradation during transit.

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Emerging Trends and Future Outlook

• Recombinant Albumin Development: Increasing investments in recombinant technologies aim to bypass plasma donation dependency, reduce pathogen risk, and improve media stability. However, recombinant human albumin is still in developmental or niche phases.
• Synthetic and Peptide-Based Alternatives: Research into synthetic substitutes may impact future API sourcing, potentially reducing reliance on plasma-derived products.
• Global Regulatory Convergence: Harmonization of standards across jurisdictions will streamline international procurement, enhancing access to high-quality API.
• Plasma Donation Expansion: Growing demand has prompted plasma collection expansion in regions like the U.S., Europe, and China, ensuring a more stable supply of plasma for albumin production.

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Conclusion

The sourcing landscape for bulk human albumin API is characterized by a handful of established plasma fractionation companies with proven regulatory credibility and production expertise. Companies like Grifols, CSL Behring, and Octapharma stand out as key global suppliers, offering high-purity, safe, and compliant API. Emerging technologies, regulatory alignment, and increased plasma collection efforts are expected to influence future procurement strategies, ultimately enhancing supply reliability and safety profiles.

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Key Takeaways

• Leading global sources include Grifols, CSL Behring, Octapharma, and Shandong Taibang, primarily offering plasma-derived human albumin API.
• Manufacturing quality relies on stringent purification, viral inactivation, and regulatory compliance, with a focus on safety and purity.
• Regulatory frameworks impact sourcing decisions, emphasizing the importance of thorough documentation of plasma donor screening and manufacturing validation.
• Logistical considerations such as cold chain management are critical in ensuring API integrity from manufacturing sites to end-users.
• Future innovations, including recombinant and synthetic alternatives, may redefine the landscape of human albumin API sourcing.

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FAQs

1. What are the primary challenges in sourcing bulk human albumin API?
   Ensuring pathogen safety, regulatory compliance, and consistent quality amid complex plasma collection and fractionation processes pose significant challenges.

2. How do regulatory agencies influence different sources of human albumin API?
   Agencies like the FDA and EMA require stringent validation, viral inactivation validation, and traceability, limiting sourcing options to compliant manufacturers.

3. Are recombinant human albumin APIs available for bulk manufacturing?
   While recombinant albumin exist for research purposes, large-scale, pharmaceutical-grade recombinant APIs are still under development and have not yet overtaken plasma-derived sources.

4. What considerations should buyers have when choosing a human albumin API supplier?
   Buyers should evaluate regulatory approvals, product purity, viral safety measures, supply stability, and manufacturing certifications.

5. What future trends could affect the human albumin API supply chain?
   Advancements in recombinant technology, increased plasma donation capacity, and global regulatory harmonization are poised to impact sourcing strategies significantly.

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References

[1] World Health Organization. (2018). Plasma-derived medicinal products: Patterns in production and regulation.
[2] European Medicines Agency. (2022). Human Serum Albumin: Guidelines on Quality, Safety, and Efficacy.
[3] U.S. Food and Drug Administration. (2021). Guidance for Industry: Viral Safety of Plasma-Derived Products.
[4] Grifols Corporate Website. (2023). Products & Quality Assurance.
[5] CSL Behring Annual Report. (2022). Production and Regulatory Compliance.