SUNNYVALE, Calif.—American Peptide Co. doesn't want to limit itself solely to peptide manufacturing, so in a bid to expand its role in the peptide and peptide conjugate space, the company has launched its new Total Peptide Management program.
Marketing it as "the first of its kind," American Peptide says Total Peptide Management offers a broad portfolio of peptides, value-added services and expert consultation to support customers as their drugs move from discovery to development and commercialization.
The notion behind the program is to help companies bring new and innovative drugs to market faster, says Takahiro Ogata, President & COO of American Peptide. The program comprises such services as process development; scale-up production; analytical and process validation; stability studies; chemistry, manufacturing and controls; drug master files and regulatory support.
"In essence, this is what we've been doing for the past 20 years," notes Gary Hu, vice president of sales and marketing for American Peptide. "This is an effort to do all of that in a more organized fashion and put it out more clearly to the marketplace."
"We don't want to offer these services in a piecemeal fashion," Hu adds. "Our approach is to be more consultative rather than make quick sales. If we just go for the quick sale, we may pay later on with problems in increasing the scale and yield of drug substances and in getting the specifications right downstream."
American Peptide has a wide-ranging customer base, from biotech startups through large pharmaceutical companies, and Hu says the program will help those clients both with scientific work and regulatory issues downstream.
"History dictates that the majority of these customers already have consulting internally or externally to take them step-by-step through the preclinical and clinical stages, but we wanted to be a bit proactive and set ourselves up as a partner within that process," Hu says.
In addition to helping customers properly select peptides and follow correct procedures and compliance guidelines to streamline drug development and manufacturing, the Total Peptide Management program is expected to facilitate greater adherence to manufacturing standards and protocols. One way it will do this is by mandating application of GMP practices to non-GMP applications in the early phases of drug development.
Marketing it as "the first of its kind," American Peptide says Total Peptide Management offers a broad portfolio of peptides, value-added services and expert consultation to support customers as their drugs move from discovery to development and commercialization.
The notion behind the program is to help companies bring new and innovative drugs to market faster, says Takahiro Ogata, President & COO of American Peptide. The program comprises such services as process development; scale-up production; analytical and process validation; stability studies; chemistry, manufacturing and controls; drug master files and regulatory support.
"In essence, this is what we've been doing for the past 20 years," notes Gary Hu, vice president of sales and marketing for American Peptide. "This is an effort to do all of that in a more organized fashion and put it out more clearly to the marketplace."
"We don't want to offer these services in a piecemeal fashion," Hu adds. "Our approach is to be more consultative rather than make quick sales. If we just go for the quick sale, we may pay later on with problems in increasing the scale and yield of drug substances and in getting the specifications right downstream."
American Peptide has a wide-ranging customer base, from biotech startups through large pharmaceutical companies, and Hu says the program will help those clients both with scientific work and regulatory issues downstream.
"History dictates that the majority of these customers already have consulting internally or externally to take them step-by-step through the preclinical and clinical stages, but we wanted to be a bit proactive and set ourselves up as a partner within that process," Hu says.
In addition to helping customers properly select peptides and follow correct procedures and compliance guidelines to streamline drug development and manufacturing, the Total Peptide Management program is expected to facilitate greater adherence to manufacturing standards and protocols. One way it will do this is by mandating application of GMP practices to non-GMP applications in the early phases of drug development.
