Fast Locator 2014-2015: Gallus - Pharmaceutical Technology

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Fast Locator 2014-2015: Gallus


Gallus BioPharmaceuticals
4766 LaGuardia Drive
St. Louis, MO 63134-3117

Regions served:
Worldwide outsourcing services

Description:
Gallus BioPharmaceuticals is a leading mammalian cell culture contract development and manufacturing organization (CMO) that offers a unique level of flexibility and strategic appeal to companies seeking to develop and manufacture biologics. As a pure-play CMO, we deliver a high level of quality and reliability to our clinical and commercial clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacturing of Stelara® and Remicade® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs and collagens, plus over 20 years of experience of commercial manufacture including the supply of ProstaScint®. Both sites maintain exemplary quality and regulatory records.

In addition to a stellar commercial manufacturing history Gallus offers clinical and commercial fill finish, a pilot facility and expanded analytics including mass spectrophotometry. Our expanded team of 370 dedicated professionals has a combined experience of nearly six decades of biologics manufacturing experience, with an exceptional focus on quality evidenced in a high frequency of tech transfers and a long-term exemplary regulatory record. We provide value for your molecule in our uniquely flexible services and business models, including utilizing advanced technologies to improve upstream and downstream processes, reduce project timelines and optimize yields.

Gallus has significantly expanded our process development laboratories and clinical services suites using single-use technologies, stainless steel and flexible stainless steel and have built our talent pool with industry-recognized expertise in cell culture, purification, analytical development and project management. Combined, Gallus’ team and facilities provide the exceptional service you seek for developing and manufacturing the biologic therapies of the future.

Website:
www.gallusbiopharma.com

Services Provided:

Analytical Services
Bioanalytical testing
Chemistry & stability
Microbiology
Particle characterization
Product characterization

Formulation Development & Phase I/II Clinical Trial Materials (CTM)
Active pharmaceutical ingredients (API)—large molecule/biologics

Biomanufacturing
Cell culture

Commercial Manufacturing
Active pharmaceutical ingredients (API) manufacturing—(cGMP, large molecules/biologics)

Other
Process development and tech transfer
Liquid fill finish

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