Navigation Links
Althea Technologies Receives FDA Approval to Initiate Commercial Manufacturing
Date:6/27/2011

SAN DIEGO, June 28, 2011 /PRNewswire/ -- Althea Technologies, Inc. announced today that following a comprehensive FDA Pre-Approval Inspection (PAI) in April 2011, it has received a license to manufacture and package a commercial parenteral product for the US market.  The product will be filled and packaged at the company's new, state-of-the-art commercial manufacturing facility located in San Diego, California.  This facility, the third on Althea's campus, was constructed to accommodate the increased demand the company has experienced in both its drug product and biologics manufacturing business units. To support this growth, the company has also expanded its analytical development, stability testing and formulation development capabilities for larger clinical and commercial projects.  

"We are very pleased with the successful outcome of our initial PAI and anticipate working with our clients to bring several other products to commercialization over the coming months," stated Rick Hancock, President of Althea Technologies.  "Our entire team feels very gratified to have achieved this major milestone.  This accomplishment is the result of thoughtful and diligent investment in expanding our quality systems, facilities and operational capabilities in a climate that has been challenging for many companies in our industry."

In the past 12 months, Althea has installed and validated a fully-automated, INOVA H3-5 syringe filling line that can accommodate high viscosity and shear sensitive products.  This line can accommodate a wide variety of glass or plastic syringes and cartridges in batch sizes exceeding 100,000 units and is a critical component of the company's expansion in commercial manufacturing.

Althea Technologies will be exhibiting at the BIO International Convention.  Please visit us at Booth #1637.

About Althea Technologies, Inc.

Althea Technologies is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services.  Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA.   In conjunction with these manufacturing operations, Althea offers comprehensive development services including:  upstream and downstream process development, analytical development, lyophilisation cycle and formulation development, product release and ICH-compliant stability testing.  Althea's formulation technology platform includes Crystalomics, a technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations.  For more information, visit www.altheatech.com.


'/>"/>
SOURCE Althea Technologies, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Althea and Biotest Establish Commercial Filling Agreement
2. Althea Technologies Announces Appointment of Rick Hancock as President
3. Althea Technologies Announces the Installation of a High-Speed Prefilled Syringe Line
4. Althea Technologies Acquires Altus Pharmaceuticals(R) Assets and IP Portfolio, Establishing Technology Platform for Protein Formulations.
5. Althea Technologies Adds Formulation Development to Its Integrated Offering of Contract Services
6. Global Technologies, Ltd. Announces LOI to Acquire and Merge with Oxygen Orchard, Inc.
7. Alan Dunton, M.D., Joins Board of Directors of Palatin Technologies, Inc.
8. Life Technologies Consortium to Create New Frontline Diagnostic Utilising DNA Sequencing for Cancer Patients in the U.K.
9. China Medical Technologies Announces Strategic Collaboration Between its Subsidiary, GP Medical, and Da An Health
10. Andrew Technologies Names Tom Albright CEO and Board Member
11. BioSpecifics Technologies Corp. Announces Board Authorization of up to $2 Million Share Repurchase Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
Breaking Medicine Technology:
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
(Date:6/24/2016)... ... ... in a crisis. Her son James, eight, was out of control. Prone to extreme mood ... something upset him, he couldn’t control his emotions,” remembers Marcy. “If there was a ... children and say he was going to kill them. If we were driving on ...
(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)... (PRWEB) , ... June 24, 2016 , ... Comfort Keepers® ... American Cancer Society and the Road To Recovery® program to drive cancer patients to ... and other adults to ensure the highest quality of life and ongoing independence. ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
Breaking Medicine News(10 mins):