Contract Services and Clinical Trials New Therapeutics Through Fermentation Technology Applications of microbial fermentation technology in
new therapeutics are expanding. SaFC offers unique cGMP fermentation-based manufacturing capabilities through its Jerusalem facility, including highly potent
aPis and biologics. SaFC scientific teams provide a complete range of services, including process evaluation and development, optimization and scale up, technology transfer, manufacturing, analytical testing and regulatory filing to help
BiologiCal TherapeuTiCs
customers bring new drugs to market faster.
Fermentation-derived biological therapeutics are used in a
SaFC is finding new applications for its expertise in
fermentation technology, including the synthesis of high
Native Proteins: Col agenases are a group of enzymes
potency active pharmaceutical ingredients (HPaPis) and
produced by the bacterial pathogen Clostridium genus. Native
therapeutics. these applications draw on the use of microbial
isolated col agenases are used in a variety of medical
biofactories, which offer the pharmaceutical industry a diverse,
indications involving col agen disorders, including Santyl®
reliable, powerful, and economic source for therapeutics, many
ointment and iruxol® for the removal of dead skin from wounds
of which are primarily isolated through microbial fermentation.
and burned areas in poorly healing wounds and necroses, as well as Xiafles dupuytren’s contracture, a condition resulting in
ChemiCal TherapeuTiCs
the contracture of the fingers into the palm. other col agenases
toxic, smal , organic molecules produced natural y by
are currently in clinical trials for indications including frozen
microorganisms in response to stress are cal ed secondary metabolites. they are used in cancer therapy and in the
Recombinant Proteins: Manufactured in various
heterologous microbial hosts, mainly bacteria, these include
Cancer Therapy: various HPaPi antibody–drug conjugates Escherichia coli, Pseudomonas fluorescens and yeast (Pichia
(adCs) are currently in clinical trials. Some are gaining Fda
pastoris). recombinant lysostaphin has been investigated in
approval for difficult-to-treat indications, mainly in the
various models for infections caused by a Staphylococcus
treatment of cancer. Wyeth’s Fda-approved Mylotarg® adC is a
aureus, either systemic or specific, such as endocarditis
recombinant humanized igG4 kappa antibody conjugated with
(inflammation of the inner layer of the heart). recombinant
a cytotoxic antitumor antibiotic, calicheamicin, which is isolated fibroblast growth factor has been implemented in various through the fermentation of a bacterium, Micromonospora
disorders, including angiogenesis in limb ischemia, tissue
echinospora subspecies calichensis. Genentech’s trastuzumab-
regeneration, cartilage injuries, wound healing, and remodeling
dM1 is an adC of immunoGen’s dM1 agent linked to
of bone and cartilage. antibody fragments are small portions of
Genentech’s humanized anti-Her2 antibody, trastuzumab
ful -length antibodies sufficient to confer therapeutic activity.
(Herceptin®, approved to treat breast cancer). dM1 is a
Fragment production with microbial systems has been
proprietary derivative of a natural y occurring substance
demonstrated with E. coli, yeasts, and fungi. various companies
belonging to the ansamycin family of secondary metabolites
have antibody fragments under development.
and is isolated through fermentation of an actinomyces species,
in addition to advanced fermentation capabilities, SaFC
offers a range of contract manufacturing services including
Treatment of Infectious Diseases: Many antibiotics are
bioconjugation, viral vectors and vaccines, protein extraction
sourced from living microorganisms, used either in their natural
and purification, and high-potent manufacturing. to learn
state or (in the case of semisynthesis) chemical y modified.
aminoglycosides are produced and isolated from bacteria of the Streptomyces genus, used in their existing form to provide
David M. Backer is director, marketing and business development,
drugs such as streptomycin (a bactericidal agent) and
6211 El Camino Real, Carlsbad, CA 92009 USA; 1-760-710-6202, fax
Hygromycin B (a kil er of bacteria and fungi). doxycycline is a
1-760-918-0788, cell 1-760-420-8148; www.safcpharma.com.
semisynthetic tetracycline. tetracyclines were isolated from
Herceptin and Lucentis are registered trademarks of Genentech. Streptomyces subspecies such as aureofaciens and rimosus.
Vibramycin is a registered trademark of Pfizer Inc. Iruxol is a registered
doxycyclin was developed in the 1960s by Pfizer and marketed
trademark of Smith & Nephew GmbH. Santyl is a registered trademark of Healthpoint Ltd. Mylotarg is a registered trademark of Wyeth.BioProcess International 23
Le 100 domande sullo screening con la sigmoidoscopia INFORMAZIONI PER OPERATORI Versione preliminare 15 marzo 2010 1. MI AVETE MANDATO UNA LETTERA 1.1 Ho ricevuto a casa la lettera dello screening: devo proprio fare la sigmoidoscopia? Non voglio fare l’esame. • La sigmoidoscopia non è obbligatoria, può fare a meno di farla. • Noi però le consigliamo di farla, perc
Invasive Plants Of Tennessee December 2009 (2nd Edition) The purpose of this list is to identify introduced plant species that are invasive or may becomeinvasive and cause damage to native plant communities. Introduced species are plants not native toa region of the state and are referred to as exotics. The intent of this list is to:• rank exotics based on their invasive characteristics;•