Meet Isogen at PDA Conference on the Development and Regulation of Clinical Trial Supplies
November 10-11, 2008
Boston, Massachusetts
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The fastest growing sector in the pharmaceutical industry is biologics. “Quality by Design (QbD)” and “The process is the product” have become long-time mottos for the regulators and companies developing new medicinal products also in this segment of the industry. Increased use of a wide variety of new technologies and expression systems makes GMP practices even more difficult to apply. Earlier stages of development and advancement of the product lifecycle through clinical stages to marketing can cause confusion about the regulatory status, since three branches of the Food and Drug Administration (FDA) are involved: the Center for Biologics Evaluation and Research (CBER); the Center for Drug Evaluation and Research (CDER); and the Office of Regulatory Affairs (ORA). In addition, compliance with international regulatory agencies is increasingly becoming a challenge.
To learn more about how Isogen enables customers to plan clinical and market launches for single or multiple therapeutics at the same time while dramatically reducing costs and risks that are inherently associated with other in-house and outsourced alternatives, schedule an appointment with Steve Tingley, Director, Business Development, at stingley@isogenllc.com or call 978.395.1096.
Meet Isogen at ISPE 2008 Annual Meeting
2008 ISPE Annual Meeting
26-29 October 2008
Boca Raton Resort and Club
Boca Raton, Florida USA
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Pharmaceutical manufacturing industry professionals from around the world will gather this October at ISPE 2008 Annual Meeting in Boca Raton, Florida, USA, to share expertise and gain insight to navigate the horizon of industry change.
To learn more about how Isogen enables customers to plan clinical and market launches for single or multiple therapeutics at the same time while dramatically reducing costs and risks that are inherently associated with other in-house and outsourced alternatives, schedule an appointment with Steve Tingley, Director, Business Development, at stingley@isogenllc.com or call 978.395.1096.
AES Modular Cleanrooms Chosen for New Isogen Facility
Focus on Contamination Control and Containment to Meet Regulatory Standards at Isogen’s New Multi-Product Advance Sterile Clinical/Commercial Contract Filling Facility
Montgomeryville, PA - March 24, 2008 - Isogen LLC has chosen AES Clean
Technology, Inc. to design and build their new cleanroom macro environment in New Castle County, Delaware, announced Cliff Satterfield, President of AES.
AES Clean Technology, Inc. is the leader in design, construction and manufacture of cleanroom facilities for life science and technology companies, specializing in modular project execution.
“We are very excited to be working with Isogen,” said Mr. Cliff Satterfield, AES
President. “This facility will demonstrate how to ’do it right’ and will provide vital clinical manufacturing capacity in the U.S. to support the pharmaceutical industry with the sterile filling of potent and non-potent compounds from development, through clinical, launch and commercial production,” said Satterfield.
“What makes this project especially significant is the approach to isolation and
containment within micro and macro environment. The concept of an isolator, within a gas-sterilizable modular cleanroom makes this contract manufacturing facility ideal for smaller volume clinical or early stage commercial fills where a dedicated filling facility is financially untenable,” said Satterfield “There is increasing concern among regulators and healthcare organizations with regard to the risk of cross contamination where potent compounds, live viruses, and cytotoxics are being filled. This concern is well documented especially in multi-product facilities, and CMOs are often used for such clinical fills”, Satterfield added.
Isogen chose modular cleanroom construction rather than traditional”stick built” construction to maximize value for the delivery of functional, adaptable cleanroom systems with the benefits of predictable cost, schedule, and quality.
“It was critical that the construction be timely and economical,” explained Austin
McDonald, Isogen COO. “AES was the obvious partner because their modular
cleanroom strategy is designed to be integrated directly into a building shell. This ’plug and play’ approach allowed us to design a building shell and drop in the cleanroom modules saving over months and significant cost versus traditional ‘stick built’ construction,” said McDonald.
Isogen CEO Les Edwards concluded, “In addition to construction efficiency,
performance is critical; the isolator cleanrooms must be both an effective barrier and be demonstrably cleanable to enable multi-product use. The integrated design of the AES modules with integrated HVAC and utility chases combined with AES design and installation expertise ensures our facility will meet the highest standards of containment,” said Edwards.
About AES
AES Clean Technology, Inc. designs, builds and manufactures cleanroom systems for critical
environments. AES manufactures the AES Pharma Cleanroom System for critical pharmaceutical and life science facilities. The cGMP wall and walk-on ceiling architectural portion of the system is manufactured at the company’s facility in Buford, GA, near Atlanta. The company’s corporate, engineering, and sales groups are headquartered in Montgomeryville, PA, near Philadelphia. For more information, please contact Linda Jones, Marketing Coordinator, 215-393-6810, Ext.112, or ljones@aesclean.com
Link to web site: AES Clean Technology
About Isogen
Isogen through their new facility in Delaware will provide advanced sterile manufacturing for potent and non-potent therapeutics for the critical clinical/commercial scale manufacturing transition. Providing a fully integrated suite of services including formulation, tech transfer and validation services for the contract filling of liquids and lyophilized formulations for vaccines, mAbs, and other synthetic and biologically derived therapeutics. For further information, contact Joe Romano, Partner, HighGround, Inc., 781-939-5800, Ext. 208, jromano@highgroundinc.com
Isogen Establishes New Paradigm for Biopharma Contract Filling to Improve Containment and Quality Standards While Significantly Reducing Sterile Manufacturing Capital Costs and Time-To-Market For New Drugs
PHILADELPHIA, March 12 /PRNewswire/ - Isogen announced it will introduce new solutions to address the pharmaceutical industry's long-standing process, facility and capacity problems associated with the low-volume clinical and early-stage commercial sterile filling market at INTERPHEX 2008. Isogen participates in the parenteral dose contract manufacturing sector, which comprises a $2 billion segment of the overall $40 billion pharmaceutical industry outsourcing market. Pharmaceutical companies are confronted with fundamental constraints that directly impact issues of time-to-market and patient access to life-saving drugs. The existing paradigm of spending tens or hundreds of millions of dollars and waiting years to build additional sterile filling capacity to address the clinical and early commercial capacity needs of large pipelines, including many orphan drugs, is exacerbated by the need to cope with the potential instantaneous skyrocketing capacity demand for drugs and vaccines associated with future pandemic or bioterrorism events.
Pharmaceutical firms have few viable options to address these issues, and each "solution" presents significant drawbacks. Building new commercial sterile filling lines for clinical fills in-house is cost prohibitive. Large contract fillers have no financial incentive to service clinical volume-size projects, while small specialist clinical fillers lack the necessary expertise and equipment to adequately deliver against a pharmaceutical company's complex needs.
"Isogen was founded to specifically address the process, facility and capacity problems commonly associated with the highly-niched, low-volume clinical and early-stage commercial sterile filling market segment," said Isogen CEO and Co-Founder Les Edwards. "Companies can easily spend upwards of $100 million and expect to take at least 4 years to develop sterile manufacturing capacity, but they are highly reluctant to do this until they are certain the candidate drug will receive regulatory approval. Isogen will accommodate vial, syringe or lyophilized vial fills ranging from a few hundred to tens or hundreds of thousands on the same equipment, with common validation and document packages, while setting new industry standards for sterility and containment assurance," said Edwards. "As a result, Isogen enables customers to plan clinical and market launches of single or multiple therapeutics at the same time while dramatically reducing costs and risks that are inherently associated with other in-house and outsourced alternatives," added COO and Co- Founder Austin McDonald.
"With significant help from Delaware and New Castle County government leaders, Isogen's new facility will be functional in 2009 and be fully operational early in 2010," said Isogen COO and Co-Founder Austin McDonald. "Isogen's outsourced processes and infrastructure will provide rapid, reliable sterile filling solutions for small clinical through early commercial batches using proprietary formulation, validation and filling equipment standards and practices in dedicated advanced barrier isolation environments," McDonald added.
Isogen leverages proprietary state-of-the-art barrier isolation technology to provide best-in-class sterile processing for potent and non-potent compounds. Isogen facilities feature multiple, standalone filling suites for liquids and lyophilized products in batch sizes from a few hundred to 30,000 vials or 100,000 syringes. Isogen's world-class technical team provides support services for sterile fill operations including formulation, technology transfer, validation studies and regulatory submissions.
About Isogen
Isogen is the leader in advanced sterile manufacturing for potent and non- potent therapeutics for the critical clinical/commercial scale manufacturing transition. Isogen provides a fully integrated suite of services including formulation, technology transfer and validation services for the contract filling of liquids and lyophilized formulations for vaccines, mAbs, and other synthetic and biologically derived therapeutics. Isogen delivers critical full service resources to pharmaceutical and biopharmaceutical manufacturers seeking solutions in advanced sterile filling including clinical and transitional contract filling, formulation/validation based analytical laboratory services and advanced sterile fill line/equipment design and GMP project management. For more information, contact Joe Romano, Partner, HighGround at +1-781-939-5800 x 208 or jromano@highgroundinc.com
Link to article: Forbes.com
Meet Isogen at INTERPHEX 2008
To learn more about how Isogen enables customers to plan clinical and market launches for single or multiple therapeutics at the same time while dramatically reducing costs and risks that are inherently associated with other in-house and outsourced alternatives, schedule an appointment with Steve Tingley, Director, Business Development, at stingley@isogenllc.com or call 978.395.1096.