Drug Delivery Technology

AMERICAN PEPTIDE:
IMPROVING DELIVERY
THROUGH SYNERGY

American Peptide Company, Inc. (APC) is a CMO offering Total Peptide Management to clients. The program is a customized service platform, which comprises a set of comprehensive services, including process development; scale-up production; analytical and process validation; stability studies; Chemistry, Manufacturing, and Controls (CMC); Drug Master Files (DMF) and regulatory support. Since the program’s launch early last year, APC has seen an increased collaboration between APC and clients in moving projects forward, explains Scott Caton, Director, GMP Quality Control at APC.

In order to achieve the desired efficacy, peptide drugs need to target the appropriate site and also have a therapeutic half-life. Patricia Haller, PhD, Director, GMP Manufacturing and Process Development at APC, believes these challenges can be overcome by engineering the peptide sequence or by conjugating the peptide to carrier molecules, such as PEG or antibodies.

American Peptide works with clients to supply engineered peptides so they can be screened for pharmacokinetic profiles and efficacy. In addition, APC has expertise in peptide conjugation and other difficult-to-manufacture peptides.

Since the acquisition by Otsuka Chemical Company (OCC) in September 2008, APC and OCC are creating new synergistic opportunities in improving drug delivery that will benefit the pharma and biotech companies.

Drug Delivery Technology September 2006 Vol 6 No 8

APC’s target clients are pharmaceutical and biotech companies using peptide-based APIs for drug discovery and consumer products development, explains Gary Hu, APC Vice President, Sales and Marketing. Therapeutic focus areas are in cancer vaccines, neurodegenerative diseases, and metabolic disorders. American Peptide has developed proprietary technologies that allow the company to quickly develop economically viable, environmentally sound, scalable manufacturing processes for peptide-based APIs.

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“Our expertise in both solid- and

FIGURE 1

Antibody-loaded PLG microparticles designed for 6-month delivery (SurModics Pharmaceuticals (formerly Brookwood Pharmaceuticals)).

solution-phase synthesis methodologies, as well as hybrids, allows us to let a specific target dictate the most appropriate synthetic methodology. This ground-up process mapping allows us to accommodate a host of unnatural functionalities commonly found in state-of-the-art peptide therapeutics, ranging from small molecule conjugates to polymer modifications,” says Firuz Shakoori, Director of Sales at APC.

“As we are in the midst of a global economic downturn, the future of the peptide industry in the coming years is far from certain,” Mr. Shakoori continues. “The API business is very dependent on research, development, and outside sourcing from Big Pharma, biotech, and academia. This situation notwithstanding, American Peptide will remain in an upbeat mode with current and future expansions and bring new technologies to enable the synthesis of a wide-range of peptide-based compounds. This is particularly important as the next generation of peptide therapeutics will be increasingly complex, far beyond naturally occurring peptide hormones, and will be critical to retain our competitive place in US-based manufacturing. We anticipate that with our expanded infrastructure and highly skilled technical staff, APC will be well-poised to partner with Big Pharma and biotech companies for the next 5 to 10 years.”

SURMODICS PHARMACEUTICALS: NEW-GENERATION ANTIBODIES

SurModics Pharmaceuticals (formerly Brookwood Pharmaceuticals) is developing injectable microparticle products for 4- to 6- month delivery of proteins. Most recent activities have been directed toward the delivery of new-generation, therapeutic antibodies in several therapeutic areas. These microparticles comprise antibody encapsulated within lactide/glycolide (PLG) excipient. Formulating and stabilizing these proteins without denaturation is a challenge that can result in the formation irreversible aggregates, explains Thomas R. Tice, PhD, Vice President of Research, SurModics Pharmaceuticals.

Surmodics’ low-shear microencapsulation process technology and formulation compositions can maintain protein integrity. Stability and release kinetics can be improved with proprietary microencapsulation technology involving conjugation of protein to hydrophilic polymers. Further, Surmodics’ key strategic investment in construction of a state-of-the-art isolator manufacturing capability allows the production of commercial products aseptically. PLG microparticles offer a long safety record of PLGs as evidenced by the many examples of drug delivery products and medical device products that are on the