article thumbnail

Considerations for a Decentralized Manufacturing Paradigm

ISPE

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. 1 (2021):48. 6540 (2021):341–42. Pharmaceutical Processing World. 1 (2021):7200. 13 July 2021. The fit-for-purpose and reduced-size POD units promote green manufacturing. 3 a b c Algorri, M., Madhyastha.

article thumbnail

Oligonucleotides: A Cornerstone for Therapeutics & More

ISPE

Towards Next Generation Antisense Oligonucleotides: Mesylphosphoramidate Modification Improves Therapeutic Index and Duration of Effect of Gapmer Antisense Oligonucleotides.” 16 (20 September 2021): 9026–41. “Oligonucleotide Therapeutics: From Discovery and Development to Patentability.” Pharmaceutics 14, no. 2 (February 2022): 260.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published 15 November 2021. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. The authors propose using Module 2.3 CPP 3 IPC Film coat weight gain (P.3.4)

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

Published 15 November 2021. The TPP defines the indication and patient population, describes usage of the product, provides dosage and administration details, explains dosage form and strengths, and lists packaging and storage requirements. The authors propose using Module 2.3 CPP 3 IPC Film coat weight gain (P.3.4)

article thumbnail

Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

In the long term, a collaboration between regulators and industry stakeholders to develop and implement harmonized guidelines for raw materials would help address flexibility challenges, prevent delays in implementing process improvements, and ensure that both regulator and industry resources are devoted to the most critical issues.