Althea offers cGMP plasmid production, protein production, formulation and filling services. Plasmid DNA and protein production are offered using both Althea’s industry-leading manufacturing process as well as client developed processes. A range of options are available for formulation and filling services ranging from semi- automated to fully- automated processes for vials and syringes. Althea is focused on offering highly responsive customer service, flexible scheduling, and rapid turnaround times to meet the requirements of both early stage clinical programs and commercial programs alike.
Penn Pharmaceutical Services Assists Althea Technologies with Importation of Clinical Trial Supplies into Europe
SAN DIEGO - December 14, 2004 – Althea Technologies, Inc., a San Diego based contract manufacturing and pharmaceutical services company, has recently utilized Penn Pharmaceutical Services' expertise to facilitate the importation of clinical trial supplies into Europe while complying with the EU Clinical Trials Directive 2001/20/EC.
In order for Althea to export clinical supplies on behalf of its clients to Europe, one of Penn's five Qualified Persons (QPs), Dr. Ken Caldicott, performed an inspection of Althea's manufacturing and testing facilities so that Technical Agreements can be produced to ensure that Investigational Medicinal Product Supplies manufactured and tested at the San Diego plant can be imported into the EU in compliance with Directive 2001/20/EC.
Mr. Alan Moore, Executive Vice President of Althea, commented, "Penn's QP services have been invaluable to us. Our clients are now assured that specific European Community regulatory expectations are addressed to permit release of clinical supplies to EC member countries. Furthermore, our clients are spared any delay and associated expenses in the release of their product to Europe in scheduling a stand-alone QP inspection of Althea's facilities as required by the Directive."
Moore also said, "Our clients have already commented to us on the value that the service provided by Althea and Penn offers them. They can benefit from seamless access to a broad service offering, for example by taking advantage of Penn's distribution of clinical supplies throughout Europe."
Director of Business Development at Penn, Dr. Chris Higgins said "With the requirements of the EU Clinical Trials Directive coming into force on 1st May 2004, Althea is one of a number of U.S companies that have sought our advice and services in this area. We currently have 5 QPs on site that are available at short notice to conduct audits thus ensuring that study timelines remain firmly on schedule."
About Althea Technologies, Inc.
Althea Technologies, a leading San Diego-based pharmaceutical services firm, provides critical manufacturing and development services that support researchers worldwide in their advancement of novel therapies and efforts to apply new genomic information. Althea's services include cGMP contract manufacturing of recombinant proteins and DNA-based therapeutics and vaccines, aseptic filling, and gene quantification using real-time PCR and gene expression analysis under GLP conditions. Additionally, Althea has introduced new services and technologies for the identification and understanding of gene signatures with innovative tools such as the company's proprietary eXpress Profiling™ technology. For more information, visit www.altheatech.com.About Penn Pharmaceutical Services Ltd.
Penn Pharmaceutical Services Ltd. is one of the UK's leading providers of outsourced, integrated pharmaceutical development services. The company offers a fully comprehensive product development service, which includes formulation and analytical development, clinical trials manufacturing, packaging and supply, contract manufacturing, CMC consultancy and Qualified Person (QP) release services to the world's leading pharmaceutical, biotechnology and healthcare companies. For more information, visit www.pennpharm.co.uk.Contact:
| Althea Technologies, Inc. Alan Moore Executive Vice President & Chief Business Officer (858) 882-0205 amoore@altheatech.com |
Althea Technologies
A leading provider of contract services to
the pharmaceutical and biotechnology industries
11040 Roselle Street | San Diego, CA 92121-1205
Toll-free 1-888-4ALTHEA
info@altheatech.com