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Suppliers and packagers for generic pharmaceutical drug: ALBUMIN HUMAN
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ALBUMIN HUMAN
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ge Healthcare | OPTISON | albumin human | INJECTABLE;INJECTION | 020899 | NDA | GE Healthcare Inc. | 0407-2707-03 | 5 VIAL, SINGLE-USE in 1 CARTON (0407-2707-03) / 3 mL in 1 VIAL, SINGLE-USE | 2002-01-02 |
| Ge Healthcare | OPTISON | albumin human | INJECTABLE;INJECTION | 020899 | NDA | GE Healthcare Inc. | 0407-2707-18 | 18 VIAL, SINGLE-USE in 1 CARTON (0407-2707-18) / 3 mL in 1 VIAL, SINGLE-USE | 2002-01-02 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Albumin, Human
Introduction
Human serum albumin (HSA) is a plasma protein widely used in clinical settings for volume expansion, treatment of burns, hypoproteinemia, and as a drug carrier. As a biologic, its production, sourcing, and distribution are governed by stringent regulatory frameworks, emphasizing safety, efficacy, and ethical sourcing. The global demand for pharmaceutical-grade human albumin has surged in recent years, prompting a diverse array of suppliers ranging from established pharmaceutical companies to specialized bioprocessing firms.
This comprehensive analysis evaluates the key suppliers of human albumin, explores their manufacturing capacities, regulatory compliance, sourcing methodologies, and regional presence, providing insights essential for stakeholders involved in procurement, investment, and regulatory navigation.
Major Suppliers of Human Albumin
1. CSL Behring
Overview: CSL Behring, headquartered in King of Prussia, Pennsylvania, is a leading manufacturer of plasma-derived therapies, including human albumin solutions. The company's extensive plasma fractionation network in Belgium, Australia, and the United States underpins its high-volume production capacity.
Production and Supply: CSL’s Human Albumin products—marketed under the brand “Albumin CSL”—are derived from pooled human plasma collected globally. The company emphasizes strict donor screening, pathogen reduction technologies, and rigorous quality control to ensure product safety and consistency.
Regulatory Status: CSL Behring's albumin products are approved by major regulatory bodies, including the FDA, EMA, and other regional agencies.
Regional Presence: North America, Europe, Asia, and the Middle East—CSL's broad footprint facilitates global supply and distribution.
Key Highlights:
- Established expertise in plasma fractionation.
- Significant capacity through its plasma collection centers and manufacturing facilities.
- Focused on pathogen safety using methods such as solvent/detergent treatment.
2. Grifols
Overview: Spain-based Grifols is a prominent player in plasma-derived therapies, including human albumin, with an extensive international presence. Its core plasma fractionation plant in Barcelona produces a standardized and high-quality product.
Production and Supply: Grifols utilizes advanced fractionation techniques from pooled plasma, incorporating pathogen reduction procedures like solvent/detergent treatment. Its albumin products are marketed across multiple continents.
Regulatory Status: Grifols’ albumin is approved globally, meeting rigorous standards such as those of the EMA, FDA, and other agencies.
Regional Presence: Europe, North America, Latin America, Asia, Middle East, and Africa.
Key Highlights:
- Extensive global plasma collection network.
- Strong focus on quality assurance and product safety.
- Significant R&D investment for innovative formulations.
3. Takeda Pharmaceutical Company
Overview: Takeda, a leading Japanese pharmaceutical giant, produces human albumin primarily through its affiliated plasma collection centers and manufacturing facilities in Japan, the US, and Europe.
Production and Supply: Takeda’s albumin is derived from pooled plasma, leveraging advanced purification and pathogen inactivation technologies. Takeda provides its products globally, emphasizing regulatory compliance and supply stability.
Regulatory Status: Approved by the PMDA (Japan), FDA, and EMA, among others.
Regional Presence: Asia, North America, Europe, and emerging markets.
Key Highlights:
- Strong legacy in plasma therapies.
- Focused on safety, efficacy, and reliable supply.
- Innovating with recombinant albumin research.
4. Biotest
Overview: German-based Biotest specializes in plasma proteins, with human albumin as a key product. Its manufacturing facilities in Europe focus on plasma-derived therapeutics.
Production and Supply: Biotest sources plasma from voluntary donors, employing state-of-the-art fractionation and virus inactivation processes. It emphasizes quality and safety standards aligned with European regulations.
Regulatory Status: Approved approvals across Europe, with compliance to EMA and other international standards.
Regional Presence: Primarily Europe, with distribution channels globally.
Key Highlights:
- Emphasis on high-quality plasma sourcing.
- Robust safety protocols.
- Engaged in research for improved formulations.
5. Kedrion Biopharma
Overview: Italian biopharmaceutical company Kedrion is a notable manufacturer and distributor of plasma-derived products, including human albumin.
Production and Supply: Kedrion’s facilities utilize plasma collected through voluntary donations, applying pathogen inactivation and purification techniques aligned with global standards.
Regulatory Status: Approved by the EMA, FDA, and other agencies.
Regional Presence: Europe, North America, Middle East, Africa, Asia.
Key Highlights:
- Focus on ethical sourcing and safety.
- Significant production capacity.
- Collaborative partnerships for plasma collection.
6. China Biologic Products
Overview: Several Chinese manufacturers have emerged as key suppliers in recent years, leveraging large-scale plasma collection and localized demand.
Production and Supply: Companies such as China Biologic Products and Hualan Biological Engineering manufacture human albumin, often targeting domestic markets due to cost advantages.
Regulatory Status: Pending or aligned with China’s National Medical Products Administration (NMPA) standards; expanding into international markets.
Regional Presence: Predominantly Asia, with increasing export ambitions.
Key Highlights:
- Cost-effective manufacturing.
- Growing regulatory compliance for international quality standards.
- Strategic partnerships and export initiatives.
Sourcing Methodologies and Regulatory Considerations
Plasma Collection and Quality Assurance
The core of human albumin production is plasma, obtained via voluntary donation or paid donations in some regions. Ethical sourcing protocols, donor screening, and testing for transfusion-transmissible infections (e.g., HIV, HBV, HCV) are mandated by international standards such as the WHO and FDA’s blood safety guidelines.
Manufacturing Processes
Fractionation techniques—such as Cohn process, chromatographic purification, and virus inactivation steps—are standard. Technologies like solvent/detergent treatment, pasteurization, and nanofiltration mitigate pathogen risks.
Regulatory Framework
Suppliers must demonstrate product safety, consistency, and efficacy through rigorous validation and clinical data submissions. Regulatory approvals by agencies such as the FDA and EMA ensure compliance with Good Manufacturing Practices (GMP) and pharmacovigilance obligations.
Global Distribution and Accessibility
Well-established suppliers have global logistics networks, ensuring on-time delivery across regions. Emerging suppliers leverage regional manufacturing advantages and local partnerships to penetrate markets.
Challenges in the Supply Chain
- Limited Plasma Donations: Regional shortages impact production capacity.
- Regulatory Barriers: Evolving international standards necessitate continuous compliance efforts.
- Pathogen Safety: Ensuring the highest safety standards remains paramount amidst emerging infectious threats.
- Pricing and Reimbursement: Balancing affordability with quality considerations influences procurement decisions.
Emerging Trends and Future Outlook
- Recombinant Albumin: Advances in biotechnology may reduce dependence on plasma, expanding supply options and addressing ethical concerns.
- Plasma Collection Innovation: Enhanced donor engagement and apheresis techniques increase plasma yields.
- Regulatory Harmonization: International efforts aim to streamline approval processes, facilitating cross-border trade.
- Expanded Regional Production: Developing countries are establishing their own manufacturing capabilities to meet domestic demands.
Key Takeaways
- The dominant global suppliers of human albumin are CSL Behring, Grifols, Takeda, Biotest, and Kedrion, each leveraging extensive plasma collection and advanced purification processes.
- Ethical sourcing, pathogen safety, and regulatory compliance are critical considerations in supplier evaluation.
- Emerging manufacturers in Asia and novel biotechnologies such as recombinant albumin present opportunities for diversification.
- Ensuring supply chain resilience involves understanding regional capabilities, regulatory environments, and market dynamics.
- Future developments may shift the landscape towards recombinant or synthetic albumin, potentially reducing reliance on plasma-dependent methods.
FAQs
Q1: What distinguishes plasma-derived from recombinant human albumin?
A: Plasma-derived albumin is obtained from pooled human plasma through fractionation, while recombinant albumin is produced via genetically engineered cells, offering a potentially safer and more sustainable alternative.
Q2: How do suppliers ensure the safety of plasma-derived albumin?
A: Suppliers implement comprehensive donor screening, testing for infectious agents, and pathogen inactivation/removal technologies like solvent/detergent treatment, nanofiltration, and pasteurization.
Q3: Are there regional differences in the quality standards for human albumin?
A: Yes, while global standards aim for harmonization, regional regulatory agencies have specific requirements. Leading suppliers comply with WHO, FDA, EMA, and other regional standards to ensure product quality.
Q4: What factors influence the choice of supplier for human albumin?
A: Considerations include regulatory approval status, manufacturing capacity, safety protocols, supply reliability, cost, and regional distribution logistics.
Q5: What is the future of human albumin production?
A: Advances in biotechnology are likely to culminate in recombinant albumin, reducing dependence on plasma donations and potentially offering enhanced safety profiles and scalable production.
Sources:
[1] CSL Behring. “Human Albumin.” CSL Behring corporate website.
[2] Grifols. “Albumin.” Grifols product portfolio overview.
[3] Takeda. “Plasma-Derived Therapies.” Takeda Annual Report.
[4] European Medicines Agency. “Guidelines on plasma-derived medicinal products.”
[5] World Health Organization. “Blood safety and availability.”
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