Navigation Links
Vetter Offers a Sterile Water-for-injection Solution with 5 Years Stability Data
Date:7/10/2013

Ravensburg (PRWEB) July 10, 2013

Vetter has broadened its portfolio for lyophilized substances. The contract development and manufacturing organization (CDMO) is now offering its filling service for high-quality sterile water for injection (sWFI) syringes with 5 years of stability data. Vetter’s stability data and bracketing concept allows a longer shelf life for drugs, and high flexibility while defining the filling volume. Vetter can also offer ready-to-submit documents for the sWFI service in Common Technical Document (CTD) format. This can considerably abbreviate the approval process.

Because innovative drugs are becoming increasingly more sensitive to environmental influences, they are often lyophilized to increase their shelf life. In a freeze-dried state, these drugs maintain their bioactivity for longer periods of time. However, before being administered they have to be reconstituted and dissolved in a solvent, after which they are ready for injection. The filling service for syringes with sterile water-for-injection (sWFI) is Vetter’s intelligent solution for safe and simple handling of the reconstitution process. The system contains the exact defined amount of solvent required by the customer in order to produce the required dosage. This helps to assure patients that they will receive the exact amount of substance needed.

Vetter’s filling service for sWFI syringes is an ideal complement to lyophilized drugs in vials and is available in 1.5 ml formats with a volume of 0.5 ml to 1.3 ml, as well as a 3 ml format with a volume of 1.4 ml to 3.0 ml. The syringe features Vetter’s V-OVS® tamper-evident closure, which is designed to give a prefilled syringe system effective protection features. Vetter supports its sWFI filling service with 5 years of stability data and can manufacture batches of up to 120,000 / 140,000 pieces. For the sWFI syringes, Vetter has ICH compliant and ready-to-submit documentation for the USA, Europe, and Japan. Validation and stability data according to USP, Ph.Eur., Ph.J., and ICH guidelines are also available.

“Lyophilized drugs are an international growth segment for CDMO’s,” says Peter Soelkner, Managing Director of Vetter. "An ever greater number of manufacturers are looking for options to enable a safe and simple administration of these drugs. Our filling service for WFI syringes represents a reliable and patient-friendly solution offering our customers high-flexibility due to Vetter’s bracketing concept, and fast time-to-market by using the ready-to-submit documents. In addition to documents for approval in the USA and Europe, we also have all the necessary documentation for Japan available for pharmaceutical and biotech firms, which can considerably abridge the approval process.”

About Vetter:

Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials. The company has extensive experience with biologics and other complex compounds, including monoclonal antibodies, peptides, interferons and vaccines. Its clientele includes the world’s top 10 pharma/biotech firms and emerging companies alike. A full-service provider, Vetter supports products throughout their lifecycles, from preclinical development through global market supply. Through its U.S. and European facilities, Vetter Development Service provides state-of-the-art support for early-stage products, with seamless transfer at Phase III to Vetter Commercial Manufacturing for large-scale production. The company is the originator of dual-chamber technology, which enables easier, safer lyophilized-drug administration; and is a leader in the use of RABS technology in cleanrooms, which mitigates risk of product contamination during the manufacturing process. Vetter has won numerous awards for innovation and quality, including top prize at the 2012 European Outsourcing Awards for its new high-speed filling line. Headquartered in Ravensburg, Germany, the company employs approximately 3,000 staff across Europe and the United States. For more information about Vetter, visit http://www.vetter-pharma.com

Contact
Vetter Pharma International GmbH
Oskar Gold
Eywiesenstrasse 5
88212 Ravensburg
Phone: +49 (0)751-3700-3706
Fax: +49 (0)751-3700-7707
E-mail: PRnews(at)vetter-pharma(dot)com
http://www.vetter-pharma.com

Read the full story at http://www.prweb.com/releases/2013/7/prweb10910487.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Fortis Offers Bachelor of Science in Nursing Degree Program to Florida Students
2. Gundersen Lutheran Offers Heart Surgery with Less Pain, Faster Recovery
3. UH Case Medical Center Offers New Therapy for Gynecologic Cancer Patients
4. Butamax Granted Core Patent for Making Biobutanol and Distillers Grains; Offers Producers Efficient, Low-Cost Production of Biobutanol
5. Big Saver: Molderizer Offers 30% Mold Remediation Products Price Cut
6. Tri-Valley Sedation Dentist Dr. Endre Selmeczy Now Offers High-quality Dental Restorations
7. Berkshire Corporation Offers Live Chat For Americas Website and Shopping Cart
8. Salimetrics Offers New Saliva Collection Aid for Easy Collection of Passive Drool Samples
9. AMRESCO Offers New Prism Protein Marker With Vibrant Colors For Easy Band Identification
10. Dr. Ross Kaplan Offers New State-of-the-Art Wrinkle, Fine Line, and Skin Texture Improvement Treatment
11. Flat lens offers a perfect image
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... 4, 2016 - New FDA action date of ... New FDA action date of July 22, 2016   ... 22, 2016   - Lifitegrast ... decade indicated for the treatment of signs and symptoms of dry ... the potential to be the only product approved in the U.S. in the past decade ...
(Date:2/4/2016)... , Feb. 4, 2016  CytoSorbents Corporation (NASDAQ: ... commercializing its flagship CytoSorb® blood filter to treat ... around the world, announced that CEO Dr. ... the Source Capital Group,s 2016 Disruptive Growth & ... the company.  Conference Presentation Details: ...
(Date:2/4/2016)... Sinovac Biotech Ltd. ("Sinovac" or the "Company") (NASDAQ: ... China , today announced that the ... February 4, 2016 a preliminary non-binding proposal letter, dated ... V-Ming ( Shanghai ) Investment Holdings Co., ... Shenzhen ) Fund Management Co., Ltd., Beijing ...
(Date:2/3/2016)... , Feb. 3, 2016  Discovery Laboratories, Inc. ... on developing aerosolized KL4 surfactant therapies for respiratory ... has approved an inducement award as a component ... its newly appointed President and Chief Executive Officer.  ... Committee on February 1, 2016 and granted as ...
Breaking Biology Technology:
(Date:1/21/2016)... India , January 21, 2016 ... According to a new market research report "Emotion Detection ... and Others), Software Tools (Facial Expression, Voice Recognition ... Regions - Global forecast to 2020", published by ... is expected to reach USD 22.65 Billion by ...
(Date:1/18/2016)... , Jan. 18, 2016  Extenua Inc., a ... simplifies the use and access of ubiquitous on-premise ... partnership with American Cyber.  ... experience leading transformational C4ISR and Cyber initiatives in ... the latest proven technology solutions," said Steve ...
(Date:1/11/2016)... Jan. 11, 2016 Synaptics Incorporated (NASDAQ: ... today announced that its ClearPad ® TouchView ™ ... won two separate categories in the 8 th ... Best Technology Breakthrough. The Synaptics ® TDDI solution ... supply chain, thinner devices, brighter displays and borderless designs. ...
Breaking Biology News(10 mins):