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Bulk Pharmaceutical API Sources for calcitonin human
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Bulk Pharmaceutical API Sources for calcitonin human
| Vendor | Vendor Homepage | Vendor Sku | API Url |
|---|---|---|---|
| Molport | ⤷ Get Started Free | MolPort-016-580-999 | ⤷ Get Started Free |
| BOC Sciences | ⤷ Get Started Free | 21215-62-3 | ⤷ Get Started Free |
| SB-PEPTIDE | ⤷ Get Started Free | SB049 | ⤷ Get Started Free |
| >Vendor | >Vendor Homepage | >Vendor Sku | >API Url |
Bulk Active Pharmaceutical Ingredient (API) Sources for: Calcitonin (Human)
Summary
Calcitonin (human) is a peptide hormone commonly used for osteoporosis, Paget's disease, and hypercalcemia management. As a critical API, its sourcing involves a complex web of manufacturing, regulatory compliance, and quality assurance. This comprehensive analysis explores major global API suppliers, production technologies, regulatory landscapes, and strategic considerations for pharmaceutical companies sourcing calcitonin (human) in bulk.
What Are the Key Characteristics of Calcitonin (Human) API?
| Property | Details |
|---|---|
| Molecular formula | C153H225N47O49S |
| Molecular weight | ~3432 Da |
| Formulation | Injectable (intravenous, subcutaneous), nasal spray |
| Source | Recombinant DNA technology or bovine/pig extract |
| Delivery method | Parenteral and nasal |
| Therapeutic uses | Osteoporosis, Paget's disease, hypercalcemia |
Key Takeaway:
Recombinant human calcitonin has largely supplanted animal-derived sources due to safety, consistency, and regulatory factors.
Who Are the Major API Suppliers for Human Calcitonin?
1. Recombinant DNA Technology-Driven Manufacturers
| Supplier | Location | Production Platform | Regulatory Status | Supply Focus |
|---|---|---|---|---|
| Novartis | Switzerland | E. coli fermentation via rDNA technology | EMA and FDA approved; marketed as Miacalcin | Global, primary source for pharmaceutical-grade API |
| BioPartners (part of US WorldMeds) | Belgium | Pichia pastoris yeast expression system | CE marking, GMP certified | Supplies recombinant calcitonin globally |
| Covalab | France | Recombinant platform | CE mark, GMP status | Focus on European markets |
2. Animal-Derived Sources (Historical and Limited Use)
| Supplier | Location | Source | Notes | Current Status |
|---|---|---|---|---|
| Bovine and porcine suppliers | Global | Bovine or pig hypophyses via extraction | Declining due to recombinant alternatives | Largely phased out; minimal current use |
Key Observation:
Recombinant production dominates due to safety concerns, regulatory hurdles, and supply consistency.
What Are the Primary Manufacturing Technologies for Calcitonin (Human) API?
| Technology | Description | Advantages | Challenges |
|---|---|---|---|
| E. coli fermentation | Expression of human calcitonin genes in bacteria | Cost-effective, high yield | Inclusion body formation, endotoxin removal |
| Yeast expression (Pichia pastoris) | Use of yeast system for peptide synthesis | Reduced endotoxin, better folding | More complex process, longer development |
| Chemical synthesis | Solid-phase peptide synthesis (SPPS) | High purity, precise sequence | Costly, scale limitations |
| Extraction from animal tissues | Historically used extraction from bovine/pig tissues | Established process, but outdated | Safety, supply, and ethical concerns |
Trend:
Recombinant DNA technology (E. coli and yeast) is now standard, improving safety and scalability.
Regulatory Landscape and Quality Standards
| Region | Regulatory Body | Standards/Guidelines | Implications for API Sourcing |
|---|---|---|---|
| United States | FDA | cGMP, IND, NDA requirements | Suppliers must meet cGMP; batch validation essential |
| European Union | EMA | GMP guidelines, Marketing Authorization | Stringent monitoring; compliance critical |
| China | NMPA (formerly CFDA) | Good Manufacturing Practice, GMP certification | Growing number of local suppliers; quality assurance necessary |
| India | CDSCO | cGMP standards | Cost-effective options; quality needs scrutiny |
Note:
API manufacturers exporting to regulated markets must adhere to Good Manufacturing Practice (GMP), with batch testing, stability studies, and documentation.
Supply Chain Dynamics
| Aspect | Details |
|---|---|
| Lead times | 6-12 months depending on batch size and regulatory approval |
| Batch sizes | Ranged from 50g to multi-kilogram scale |
| Pricing (approximate) | $10,000 to $50,000 per gram, highly variable based on purity, source, and volume |
| Quality certifications | GMP, ISO 9001, ISO 13485, USFDA approvals |
Comparison of Key Suppliers
| Parameter | Novartis | BioPartners/US WorldMeds | Covalab |
|---|---|---|---|
| Production Platform | E. coli fermentation | Yeast (Pichia pastoris) | Recombinant E. coli |
| Global Reach | Yes | Yes | Europe-focused |
| Regulatory approvals | EMA, FDA | CE, GMP | CE, GMP |
| Pricing competitiveness | Premium | Competitive | Variable |
| Supply reliability | High | High | Moderate to high |
Strategic Considerations for Sourcing Calcitonin (Human) API
| Factor | Implication |
|---|---|
| Regulatory compliance | Choose suppliers with proven GMP certification and regulatory approvals |
| Supply security | Diversify sources, prioritize suppliers with robust manufacturing capacity |
| Cost factors | Balance between quality and price; recombinant sources generally cost more |
| Intended formulation | Ensure API form matches intended drug formulation (e.g., injectable, nasal) |
| Technological compatibility | Confirm compatibility with manufacturing processes of different peptides |
Comparison: Animal-Derived vs. Recombinant Human Calcitonin APIs
| Characteristic | Animal-Derived API | Recombinant Human API |
|---|---|---|
| Safety profile | Higher risk of prion transmission, immunogenic reactions | Safer, reduced immunogenicity |
| Consistency | Variable, batch-to-batch fluctuations | High batch-to-batch consistency |
| Regulatory acceptance | Limited; mostly phased out | Widely approved and preferred |
| Production complexity | Extraction-heavy, less scalable | Scalable, molecularly precise |
| Ethical concerns | Present | Minimal |
FAQs
1. What are the key regulatory challenges in sourcing calcitonin (human) API?
Regulatory challenges include ensuring GMP compliance, demonstrating batch consistency, verifying purity levels, and adhering to regional regulations such as FDA, EMA, or NMPA standards. Recombinant sources tend to facilitate regulatory approval due to safety and consistency advantages.
2. Which manufacturing technology provides the best balance of cost and quality?
E. coli fermentation using recombinant DNA technology offers a cost-effective, high-yield, high-quality API, making it the preferred method for large-scale production.
3. Are there any emerging sources or technologies for calcitonin (human) API?
Yes. Advances in synthetic biology, such as cell-free protein synthesis and improved yeast expression systems, are under exploration. These aim to optimize yields, reduce costs, and improve quality.
4. How do I evaluate the reliability of an API supplier?
Assess GMP certification, regulatory track record, production capacity, supply history, quality controls, and customer references. Site audits and batch validation reports are recommended.
5. What are cost considerations in sourcing recombinant calcitonin API?
Cost factors include raw material expenses, fermentation and purification processes, regulatory compliance costs, and volume discounts. While recombinant API tends to be more expensive than animal-derived sources historically, it aligns better with current regulatory and safety standards.
Key Takeaways
- The transition from animal-derived to recombinant human calcitonin has transformed sourcing dynamics by enhancing safety, consistency, and regulatory acceptance.
- Major global suppliers include Novartis and specialized biotech firms using E. coli or yeast fermentation platforms.
- Regulatory compliance and quality assurance are paramount; GMP certification is non-negotiable for pharmaceutical-grade API.
- Cost strategies should balance quality requirements with supply reliability, considering the benefits of long-term partnerships.
- Emerging technologies and manufacturing advances promise more efficient, cost-effective, and safer point-of-care production methods in the future.
References
[1] U.S. Food and Drug Administration. "Guidance for Industry: Quality Systems Approach to Pharmaceutical Quality Management." 2021.
[2] European Medicines Agency. "Guideline on the Requirements for the manufacture of human calcitonin." 2017.
[3] World Health Organization. "Guidelines on the Production and Quality Control of Peptides." 2019.
[4] Novartis AG. "Miacalcin (Calcitonin-Salmon) Product Monograph." 2020.
[5] US WorldMeds. "BioPartners: Recombinant Human Calcitonin Overview." 2022.
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