Corporate Banner
Satellite Banner
Biologics & Bioprocessing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Vetter Offers a Sterile Water-For-Injection Solution with 5 Years Stability Data

Published: Wednesday, July 10, 2013
Last Updated: Wednesday, July 10, 2013
Bookmark and Share
Ready-to-submit documentation for the USA and Europe, and now Japan.

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.”


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,500+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Vetter Development Service Chicago Completes Recent On-Site Expansion Activities
Continued demand and increased customer product transfers are generating a positive business outlook for the company’s early-stage development facility.
Thursday, June 11, 2015
Vetter Continues to Expand Capacity
Structural work completed on Vetter’s new multi-functional building for its Development Service and information technology (IT).
Friday, January 30, 2015
Vetter Adds Flexible Serialization Service to its Portfolio
A new service allowing for the explicit identification of drug packaging.
Thursday, December 04, 2014
Vetter Announces Opening of Office to Support Growing Asian Healthcare Market
New Asia Pacific office will support customer relations and the development of new business.
Friday, November 21, 2014
Vetter to Construct New Filling Lines to Expand Capacity
Responding to customer demand and company growth.
Thursday, October 10, 2013
Vetter’s New Commercial Filling Line Ready for cGMP Filling
Novel, high-tech line fully validated; first customer project underway.
Monday, April 08, 2013
Vetter’s Newest Facility Successfully Completes FDA Inspection
Center for visual inspection and logistics sets high safety and control standards.
Thursday, March 28, 2013
Vetter Offers Answers for the Future at the Pharma Congress 2013
Experts from the CDMO to discuss the challenges and solutions facing the industry.
Tuesday, February 19, 2013
Vetter Receives Top Prize at the European Outsourcing Awards Ceremony
CDMO clinches an industry Oscar for its innovative high-speed filling line.
Friday, October 12, 2012
Scientific News
New Vaccine For Chlamydia to Use Synthetic Biology
Prokarium Ltd, a biotechnology company developing transformational oral vaccines, have announced new funding from SynbiCITE, the UK’s Innovation and Knowledge Centre for Synthetic Biology.
Researchers Discover Immune System’s 'Trojan Horse'
Oxford University researchers have found that human cells use viruses as Trojan horses, transporting a messenger that encourages the immune system to fight the very virus that carries it.
How to Become a Follicular T Helper Cell
Uncovering the signals that govern the fate of T helper cells is a big step toward improved vaccine design.
First Artificial Ribosome Designed
Researchers at the University of Illinois at Chicago and Northwestern University have engineered a tethered ribosome that works nearly as well as the authentic cellular component, or organelle, that produces all the proteins and enzymes within the cell.
Experimental MERS Vaccine Shows Promise in Animal Studies
A two-step regimen of experimental vaccines against Middle East respiratory syndrome (MERS) prompted immune responses in mice and rhesus macaques, report National Institutes of Health scientists who designed the vaccines.
Sweet Revenge Against Superbugs
A special type of synthetic sugar could be the latest weapon in the fight against superbugs.
Researchers Develop Vaccine that Protects Primates Against Ebola
A collaborative team from The University of Texas Medical Branch at Galveston and the National Institutes of Health have developed an inhalable vaccine that protects primates against Ebola.
Universal Flu Vaccine in the Works
A new study has demonstrated a potential strategy for developing a flu vaccine with potent, broad protection.
Immunotherapy Shows Promise for Myeloma
A strategy, which uses patients’ own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable.
Ferring Bets on Bacteriophages to Treat Inflammatory Bowel Disease
Ferring Pharmaceuticals have annoucned that it will collaborate with Intralytix in the latest phase of its early stage development programme for a bacteriophage-based therapy for inflammatory bowel disease (IBD).
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!