Navigation Links
Isogen Launches Major New Facility to Address Global Biopharma Demand
Date:11/19/2008

NEWARK, Del., Nov. 19 /PRNewswire/ -- Isogen, a contract development and manufacturing organization for sterile filling, today announced the first phase launch of its contract facility in Delaware. Isogen was founded to specifically address the process, facility and capacity problems commonly associated with the $2 billion highly-niched, low-volume clinical and early-stage commercial sterile filling market segment.

Companies can invest over $100 million and four years to develop sterile manufacturing capacity, but are highly reluctant to take this initiative until they are certain the candidate drug will receive regulatory approval. Isogen's Phase I facility will accommodate GMP vial and syringe filling, ranging in fill size up to 4,000 units per shift in fully segregated, isolator-based fill lines in a potent capable facility. Isolator-based lyophilization capacity is planned for later in 2009. The January 21st facility launch sets a new industry standard for GMP compliant clinical manufacturing and containment, enabling Isogen's customers to plan and execute the supply of integrated sterile clinical and small scale commercial 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.

"Isogen's facility launch will help our customers address major industry dynamics that are reshaping the face and complexity of sterile clinical trials materials supply," said Les Edwards, CEO, Isogen. "Regulators in the U.S. and Europe increasingly require sterile clinical trials supplies to be manufactured in accordance with current Good Manufacturing Practice (cGMP) standards. At the same time many new pipeline drugs moving into clinical trials require Isogen's unique barrier isolation containment technology. Our process ensures safe manufacturing, while meeting strict global regulatory standards," Edwards concluded.

Isogen will offer an integrated GMP clinical and early commercial contract filling service comprising sterile process development, analytical laboratory services and pharmaceutical engineering consulting. Isogen's Advanced Sterile Filling offers full product segregation and isolator-based sterile processing. The facility meets global regulatory standards and operates according to cGMP. Isogen's industry subject matter experts and a combination of its analytical pharmaceutical laboratory and engineering service functions make Isogen a fully integrated Contract Development and Manufacturing Organization (CDMO) capable of supporting client contract from formulation to distribution.

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, monoclonal antibodies 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


'/>"/>
SOURCE Isogen
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Oramed Pharmaceuticals Launches Phase 1A Trials of its Insulin Suppository
2. Photos: NIH Launches New Web Site for Parents on Medical Research Studies for Children
3. Video: Sirion Therapeutics Launches Durezol for Postoperative Ocular Inflammation and Pain
4. Xalieve(TM) Gains Momentum as Calabar AB Launches a Phase II Repeated Dose Study in Dry Mouth Patients
5. Good Samaritan Hospital Launches High Risk Breast Cancer Program at Good Samaritan North Health Center
6. Coapt Systems Launches FDA Cleared Novielle Voice (TM) for Restoration of Voice Loss
7. Oramed Pharmaceuticals Launches GLP1-Analog Program, Based on its Proprietary Drug Delivery Platform
8. Agendia Launches TargetPrint(R) for Breast Cancer Patients
9. Aon eSolutions Launches Clinical Trials Module
10. Landmark HIV/AIDS Publication Launches at International AIDS Society Conference in Mexico City
11. Interleukin Genetics Launches Enhanced Heart Health Genetic Test Report Format
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016 Any dentist who has made an ... current process. Many of them do not even offer this ... and high laboratory costs involved. And those who ARE able ... such a high cost that the majority of today,s patients ... Parsa Zadeh , founder of Dental Evolutions Inc. and ...
(Date:6/23/2016)... , June 23, 2016 ... CAPR ), a biotechnology company focused on the ... announced that patient enrollment in its ongoing randomized ... has exceeded 50% of its 24-patient target. Capricor ... the third quarter of 2016, and to report ...
(Date:6/23/2016)... , June 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with ... Latin America . ... ... ... ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... Oklahoma (PRWEB) , ... June 25, 2016 , ... ... both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures ... Oklahoma City area —Johnson is one of the first doctors to perform the ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced ... feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as a ... has released tools for healthy coping following a traumatic event. , Trauma sufferers tend ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Global law firm ... 2016 Legal Elite. The attorneys chosen by their peers for this recognition are considered ... Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal Elite ...
(Date:6/24/2016)... ... , ... People across the U.S. are sharpening their pencils and honing their ... in which patients and their families pay tribute to a genetic counselor by nominating ... of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. , In April, ...
Breaking Medicine News(10 mins):