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:3/23/2017)... 2017 Research and Markets has announced the ... to their offering. ... The global capillary electrophoresis market to grow at a CAGR ... Global Capillary Electrophoresis Market 2017-2021, has been prepared based on an ... the market landscape and its growth prospects over the coming years. ...
(Date:3/23/2017)... , March 23, 2017  Drug diversion is ... misuse and deadly overdoses. A new oral fluid ... www.cordantsolutions.com , reports more detailed and actionable ... can potentially improve therapy adherence, patient safety, and ... Cordant Comprehensive Oral fluid Rx Evaluation (CORE) system ...
(Date:3/23/2017)...  A new genetic test has been discovered ... who carry HLA-B*15:02 and who are ... deadly side effect of certain medications used to ... HLA-B*15:02 is strongly associated with life-threatening severe ... toxic epidermal necrolysis in patients treated with carbamazepine ...
Breaking Medicine Technology:
(Date:3/23/2017)... , ... March 23, 2017 , ... The MBI “Hall of Fame” recognizes the contributions ... have had a significant impact on the careers of all others involved. , ... was inducted into the MBI’s Hall of Fame. The induction took place during the ...
(Date:3/23/2017)... ... March 23, 2017 , ... March is National Kidney ... a punch when it comes to maintaining good health. Every day, two kidneys filter ... kidneys filter every drop of your blood, eliminating waste, regulating fluid levels and blood ...
(Date:3/23/2017)... , ... March 23, 2017 , ... ... in Los Angeles based healthcare technology company California Healthcom Group (CHG). , ... US, and healthcare arena. With headquarters in California, CHG is a growing, internationally ...
(Date:3/23/2017)... ... March 23, 2017 , ... Michael Lanteri ... the greater Fort Collins area, has unveiled a collaboration with nonprofit Big Bones ... Donations to this worthy cause may now be made at http://bigbonescaninerescue.com/ . ...
(Date:3/23/2017)... ... 23, 2017 , ... Altec Products, Inc. , a ... their 2016 Microsoft Dynamics Partner of the Year at DocLink Evolution , ... recognizes The Resource Group for their outstanding relationship with Altec and their ability ...
Breaking Medicine News(10 mins):