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," Edwar
'/>"/>

SOURCE Isogen
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

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:5/4/2015)... SOMERSET, N.J. , May 4, 2015 ... 20 percent seek help. During May – National Hearing ... hearing loss could be missing out on the sounds ... through the trees. To ensure that you ... sounds that color our world, Oticon, Inc. offers practical ...
(Date:5/4/2015)... -- Impax Laboratories, Inc. (NASDAQ: IPXL ) announced that ...  Donna M. Hughes, as Senior Vice President, Human Resources ... President, Chief Compliance Officer. Both Ms. Hughes and Ms. ... Officer, Fred Wilkinson . "We are ... team," said Fred Wilkinson , President and Chief ...
(Date:5/4/2015)... Bayer HealthCare (Bayer) has entered into an ... ISIS ) on ISIS-FXI Rx, an antisense investigational ... Under the agreement Bayer will further develop and commercialize ... need. As part of the clinical development program, Bayer ... in an appropriate patient community. "Bayer ...
Breaking Medicine Technology:It's Better Hearing Month 2Impax Strengthens Leadership Team by Adding New Senior Vice Presidents for Human Resources and Compliance 2Impax Strengthens Leadership Team by Adding New Senior Vice Presidents for Human Resources and Compliance 3Bayer Licenses Investigational ISIS FXI(Rx) from Isis Pharmaceuticals to Develop and Commercialize for the Prevention of Thrombosis 2Bayer Licenses Investigational ISIS FXI(Rx) from Isis Pharmaceuticals to Develop and Commercialize for the Prevention of Thrombosis 3
... ... at ADA 2008, ... today announced data showing that the use of mealtime,SYMLIN(R) (pramlintide acetate) ... achieving diabetes treatment goals of,improved glucose control without weight gain or ...
... Alexza,Pharmaceuticals, Inc. (Nasdaq: ALXA ) announced today ... with AZ-002 (Staccato(R),alprazolam) in patients with panic disorder. ... which were the effect of AZ-002 on the ... of AZ-002 on the duration of a,doxapram-induced panic ...
Cached Medicine Technology:Use of Mealtime SYMLIN(R) Compared to Rapid-Acting Insulin for Diabetes Therapy Intensification in Patients With Type 2 Diabetes Using Basal Insulin 2Use of Mealtime SYMLIN(R) Compared to Rapid-Acting Insulin for Diabetes Therapy Intensification in Patients With Type 2 Diabetes Using Basal Insulin 3Use of Mealtime SYMLIN(R) Compared to Rapid-Acting Insulin for Diabetes Therapy Intensification in Patients With Type 2 Diabetes Using Basal Insulin 4Use of Mealtime SYMLIN(R) Compared to Rapid-Acting Insulin for Diabetes Therapy Intensification in Patients With Type 2 Diabetes Using Basal Insulin 5Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder 2Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder 3Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder 4
(Date:5/4/2015)... TROY Healthcare Solutions is proud to be a ... (RUG) Conference in Baltimore, MD from May 11 – ... provides an opportunity for clients to gather to network, ... In addition to sponsoring the event, TROY Healthcare Solutions ... Conference. Attendees can stop by the TROY booth and ...
(Date:5/4/2015)... In May of 2010, after two years of constant ... wake of this tragedy, Ty’s parents Kirk and Laura Smalley ... grim reality of bullying and its devastating consequences. Stand for ... to share their story and offer education and tools that ... — a mission that took the Smalley family all the ...
(Date:5/4/2015)... DC (PRWEB) May 04, 2015 EY ... Kit Check as a finalist for the EY Entrepreneur ... Region. The awards program recognizes entrepreneurs who demonstrate ... financial performance and personal commitment to their businesses and ... by a panel of independent judges. Award winners ...
(Date:5/4/2015)... Ill., (PRWEB) May 04, 2015 New ... American Brain Tumor Association (ABTA) show that people diagnosed ... diagnosis and treatment options, including clinical trials, at the ... days to make difficult decisions about their course of ... launch of the first nationwide brain tumor volunteer network, ...
(Date:5/4/2015)... 2015 Dr. Benjamin Stong of Kalos ... the latest non-surgical double-chin eliminator. Dr. Stong is ... in Atlanta to offer Kybella treatments . The ... specifically under the chin, promising to safely dissolve fat ... patients who sought immediate solutions for their double chin ...
Breaking Medicine News(10 mins):Health News:TROY Healthcare to Exhibit at the Cerner North Atlantic Regional User Group Conference 2Health News:TROY Healthcare to Exhibit at the Cerner North Atlantic Regional User Group Conference 3Health News:WWE Legend "Rowdy" Roddy Piper Teams Up with Stand for the Silent for Timely Anti-Bullying Campaign 2Health News:WWE Legend "Rowdy" Roddy Piper Teams Up with Stand for the Silent for Timely Anti-Bullying Campaign 3Health News:EY announces Kit Check CEO and Co-founder Kevin MacDonald as an EY Entrepreneur Of The Year® 2015 Award finalist in the Greater Washington Region 2Health News:American Brain Tumor Association Poll Underscores Need for Greater Awareness and Education at Time of Diagnosis 2Health News:American Brain Tumor Association Poll Underscores Need for Greater Awareness and Education at Time of Diagnosis 3Health News:Facial Plastic Surgeon First in Atlanta To Offer Kybella Treatments To Reduce Chin Fat 2
... LAKEWOOD, Colo., Nov. 7 Mesa Laboratories,Inc. (Nasdaq: MLAB ... fiscal second quarter and six months ended September 30, 2007. ... 16% * Second quarter net income increases ... 39% For the second quarter of fiscal 2008, net ...
... cut their risk for neurodevelopmental trouble, researchers say, , , ... they couldn,t live without their morning coffee, but caffeine ... tiny premature infants. , New research finds that high ... early -- an average of 27 weeks gestation -- ...
... is ,Biomedical and Health Informatics, From,Foundations to ... 7 The American Medical,Informatics Association (AMIA) ... research and development in biomedical and health,informatics ... of hot topics,including privacy and security of ...
... Nov. 7 Isolagen(TM), Inc. (Amex:,ILE) announces the initiation ... for the treatment of moderate to severe,acne scars. Isolagen ... evaluate the Isolagen Therapy in treating nasolabial folds, or ... from acne which often scars, a,condition that can be ...
... drug program the largest of its kind, CLEVELAND, ... improving the health and wellness of its customers,supermarket retailer ... 8, 2007, the company will expand its popular $4 ... than 400. The program makes commonly prescribed dosages, ...
... But Zocor, a statin, still offers significant heart benefits, ... Lowering your cholesterol could interrupt your slumber. , A ... patterns in some users. , "The study suggests that ... said Dr. Sidney Smith, past president of the American ...
Cached Medicine News:Health News:Mesa Labs Reports Higher Quarterly Sales and Earnings 2Health News:Mesa Labs Reports Higher Quarterly Sales and Earnings 3Health News:Mesa Labs Reports Higher Quarterly Sales and Earnings 4Health News:Mesa Labs Reports Higher Quarterly Sales and Earnings 5Health News:Caffeine Therapy Boosts Preemies' Outcomes 2Health News:Caffeine Therapy Boosts Preemies' Outcomes 3Health News:AMIA's 31st Annual Symposium Opens in Chicago, IL 2Health News:AMIA's 31st Annual Symposium Opens in Chicago, IL 3Health News:Isolagen Initiates Phase III Clinical Program to Investigate Isolagen Therapy(TM) for the Treatment of Acne Scars 2Health News:Isolagen Initiates Phase III Clinical Program to Investigate Isolagen Therapy(TM) for the Treatment of Acne Scars 3Health News:Giant Eagle Expands Popular Generic Prescription Program and Now Offers '400 for $4' 2Health News:Cholesterol Drug Tied to Sleep Disturbances 2
Sonogage introduces a new generation of A-Scan biometers for visual axis measurements and IOL calculations. The Eye-Scan™ employs the latest electronic and transducer technologies for unsurpass...
Improve your refractive outcome, with AXIS II precision biometry A-scan. Biometry clinically proven as accurate as partial coherence interferometry while not limited by dense media....
... measurement modes (Phakic, Aphakic, and IOL mode), ... length measuring mode. Normal phakic mode measures ... conversion at 1550m/s. The new Phakic 2 ... sonic velocity for conversion: anterior chamber and ...
... Combination A-Scan/Pachymeter with graphic display ... A-scans and A-Scan/Pachymeter combination units include ... Dioptimum and Binkhorst II formulas. Audible ... you get to visual axis. Constant ...
Medicine Products: