Industry 4.0, or the fourth industrial revolution, refers to the automation and digitalization of traditional industrial processes through smart technology and integration. Within this concept, a “smart factory” is characterized by machines which are interconnected,...
An effective CMC strategy for any peptide API should include risk mitigation approaches suitable for the intended clinical or commercial phase. The development and technology transfer of a Peptide API process (e.g. Lanreotide) will be presented as a case study in...
ABOUT THE EVENT Peptide and oligonucleotide drugs are versatile therapeutics with a growing range of applications and many similarities in terms and of manufacturing and regulation. New formulations often increase the complexity of the products and demand innovative...
ABOUT THE EVENT In its continuous efforts to facilitate and support the development and market authorization of complex generic drugs FDA has recently finalized the Guidance for Industry “ANDA for Certain Highly Purified Synthetic Peptide Drug Product That Refer to...
ABOUT THE EVENT Throughout the production of APIs (active pharmaceutical ingredients), meeting high yield and high purity during the purification step still represents a tremendous challenge. On the other hand, demands for large batch sizes of peptide APIs are...
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