How to Source Tafasitamab‑cxix for Pharmaceutical Formulation

Tafasitamab‑cxix (Injection, 200 mg) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Monjuvi (USA), Minjuvi (EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Tafasitamab‑cxix for formulation, R&D, or bulk manufacturing.

Product Overview: Tafasitamab‑cxix is a humanized, Fc‑engineered monoclonal antibody targeting the CD19 protein on B‑cell surfaces. It is used intravenously in combination with other therapies (e.g., lenalidomide) to treat relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) in adults not eligible for stem cell transplant. The antibody recruits immune effector cells to kill malignant B cells. It is supplied as a 200 mg powder for infusion. Tafasitamab represents a modern immunotherapy option in aggressive B‑cell lymphomas.

1. Regulatory Compliance & Documentation

Ensure suppliers provide:

• ✔ Valid DMF (Drug Master File)
• ✔ COA (Certificate of Analysis) for each batch
• ✔ GMP, ISO, or ICH Q7 compliance certificates

2. Purity, Grade & Specification Matching

Tafasitamab‑cxix must meet exact grade and purity for your dosage form:

• ✔ USP / EP / JP grade verification
• ✔ Particle size distribution check
• ✔ Residual solvent and heavy metal limits

3. Supplier Reliability & Audit History

• ✔ Positive past audit reports
• ✔ Pharma client references
• ✔ Years of proven API manufacturing experience

4. Commercial Terms: Pricing, MOQ & Flexibility

• ✔ Transparent pricing
• ✔ Pilot batch MOQ flexibility
• ✔ Volume-based discounts

5. Lead Time, Inventory & Logistics

Typical lead time for Tafasitamab‑cxix is 4–6 weeks.

• ✔ Emergency dispatch options
• ✔ Regional warehousing
• ✔ Special storage if needed

6. Formulation Support

• ✔ Technical datasheets
• ✔ Sample availability
• ✔ Stability study support

Conclusion

Sourcing Tafasitamab‑cxix is more than procurement—it’s a strategic partnership. With its injection form and 200 mg specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.

Frequently Asked Questions For Sourcing of Tafasitamab‑cxix