Navigation Links
White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
Date:2/24/2009

AGAWAM, Mass., Feb. 24 /PRNewswire/ -- Biopharmaceutical manufacturers, responsible for an extensive repertoire of products -- including recombinant proteins, monoclonal antibodies, and vaccines -- are faced with many aspects of testing specific to the type of product being assessed. A new whitepaper from Microtest Laboratories discusses the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer and provider of contract manufacturing testing services.

The white paper, "Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product," focuses on what many consider the most critical part of a biological drug product's manufacturing life cycle: going from the purified bulk drug substance ("PBDS") to the sterile final drug product ("FDP"). It is available for download at: http://www.microtestlabs.com/control-environment.

Specifically, the white paper discusses establishing the testing "where and when" (and in some instances the "why") for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.

In the white paper, the authors:

  • Warn to test only when necessary to reduce interventions.
  • Explain to test using methods that give data as quick as fittingly possible to condense processing times.
  • Discuss how to utilize a client's knowledge of the product, the contractor's knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.

The white paper is authored by John Dobiecki, Vice President of Manufacturing Operations, and Alex Mello, Director of Project Management, Manufacturing, both of Microtest Laboratories (www.microtestlabs.com), a contract manufacturer and provider of contract manufacturing testing services.

To download the white paper, "Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product," visit: http://www.microtestlabs.com/control-environment.

About Microtest

Microtest is a leader in aseptic processing contract manufacturing and contract manufacturing testing services for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

Available Topic Expert(s): Steve Richter, Ph.D.

For information on the listed expert(s), click appropriate link.

https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. White Nose Syndrome: Is Pennsylvania Next?
2. AHF Seeks White House Clarification After Press Room Flap Over CDCs HIV Numbers
3. ImmuneRegen BioSciences, Inc. Demonstrates Radilex(TM) Increases Disease-Fighting White Blood Cells
4. Groundbreaking Paper Publishes Long Term Results of a Successful Phase I Clinical Trial Using Autologous Neural Stem Cells to Treat Parkinsons Disease
5. AAOMS Updates BRONJ Position Paper
6. Bioimpedance Spectroscopy is More Accurate and Reliable Than Other Methods of Subclinical Assessment of Lymphedema in Breast Cancer Patients, According to Paper Published in Journal of Clinical Oncology
7. Paper in Molecular Cancer Therapeutics Reports that a Novel Combination of Alfacells ONCONASE(R) and Rosiglitazone Induces a Synergistic Apoptotic Effect in Several Cancer Cell Lines
8. Journal of Antimicrobial Chemotherapy Paper Supports Additional Role for Cethromycin as Potential Treatment for Infections Caused by Community- Associated Methicillin Resistant Staphylococcus Aureus (CA-MRSA)
9. Biomoda to Present Paper on Enhanced Technology for Early Detection of Lung Cancer at Annual SWARM Meeting
10. Bionovo Announces Publication of the Paper Detailing the Mechanism of Action of Its Cancer Drug BZL101
11. Rexinoid Developed by NuRx Pharmaceuticals Shows Promise in Prevention, Treatment of Lung, Breast Cancer, Paper in Clinical Cancer Research Reports
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... , Oct. 11, 2017  Caris Life Sciences ... on fulfilling the promise of precision medicine, today announced ... joined Caris, Precision Oncology Alliance™ (POA) as its 17 ... centers, the St. Jude Crosson Cancer Institute will help ... the use of tumor profiling, making cancer treatment more ...
(Date:10/10/2017)... COUNTY, Calif. , Oct. 10, 2017  NDS received FDA ... Mobile  — a medical-grade battery-powered display stand specifically designed for endoscopy ... to transform technology into a clinical solution to support the improvement ... Innovative Design ... ZeroWire Mobile Wireless Solution ...
(Date:10/5/2017)... ROSEMONT, Ill. , Oct. 5, 2017 /PRNewswire-USNewswire/ ... American Association of Oral and Maxillofacial Surgeons (AAOMS) ... than opioids – to be used as a ... post-surgical pain. ... relationship, the AAOMS White Paper "Opioid Prescribing: Acute ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... October 12, 2017 , ... ... that we intend to develop to enable prevention of a major side effect ... hearing loss, especially in pediatric patients. For cisplatin, hearing loss is FDA listed ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in healthcare ... Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during ... , The annual award competition recognizes editorial and design excellence across a range of ...
(Date:10/12/2017)... ... , ... On Saturday, October 21, the Health & Wellness Center at Florida ... money for the American Heart Association Heart Walk. Teams of up to 10 people ... keep their treadmills moving for 5 hours. Treadmills will start at 7:00 p.m. on ...
(Date:10/12/2017)... ... 2017 , ... Health Literacy Innovations (HLI), creator of the ... the Cancer Patient Education Network (CPEN), an independent professional organization that shares best ... alliance. , As CPEN’s strategic partner, HLI will help support CPEN members ...
(Date:10/12/2017)... Miramar, FL (PRWEB) , ... October 12, 2017 ... ... is presenting the latest in wound care advancements to physician colleagues, skilled nursing ... lecture is titled, "Navigating the Treacherous Waters of Wound Care." , "At many ...
Breaking Medicine News(10 mins):