Navigation Links
White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
Date:8/12/2008

AGAWAM, Mass., Aug. 12 /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 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 (http://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 http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.
Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Steve Richter, Ph.D. https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. New White Paper Details Strategies for Biotechnology Companies to Improve EH&S Compliance
2. Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers
3. New White Paper Details Six Steps to Investigate and Prevent Laboratory Accidents
4. Microtest Offers Free White Paper: Virus Testing for Biological Products: Partnering With a Contract Lab
5. Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers
6. Medco Chooses AllPoints at Anson in Whitestown, Indiana as Site for the Worlds Largest, Most-Advanced Automated Pharmacy
7. Free White Paper Helps Biotech Laboratories Maintain a High Level of Infection Control
8. Free White Paper Available for Clinical Laboratory Managers: Effectively Isolating Anaerobic Bacteria
9. White Paper Details Infection Control Challenges Hospitals Must Address During Construction
10. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
11. Marteks lifesDHA(TM) Now Featured in Two New Flavors of Rachels(R) Wickedly Delicious Yogurt from WhiteWave Foods
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/16/2017)...  Champions Oncology, Inc. (NASDAQ: CSBR ), ... advanced technology solutions and products to personalize the development ... of new cohorts of PDX models to their existing ... Champions, product line in hepatocellular cancer, breast cancer, castrate ... non-small cell lung cancer (including EGFR mutation; ALK/ROS1 positive) ...
(Date:2/16/2017)... Feb. 16, 2017  Rhythm, a biopharmaceutical ... deficiencies that result in life-threatening metabolic disorders, ... million mezzanine round of financing with existing ... Capital, New Enterprise Associates, Pfizer Venture Investments, ... healthcare investment fund. Rhythm will use the ...
(Date:2/15/2017)... ... February 15, 2017 , ... Executive ... Chief Commercial Officer with GenePeeks. Matt is a veteran life sciences and ... computational genomics company focused on identifying inherited disease risk in future generations. In ...
(Date:2/15/2017)... , Feb. 15, 2017  NASA provider SpaceX is ... to the  International Space Station  no earlier than 10:01 ... launch will begin at 8:30 a.m. on NASA Television ... Dragon spacecraft will lift off on the company,s ... Kennedy Space Center in ...
Breaking Biology Technology:
(Date:2/3/2017)... , Feb. 3, 2017 A new independent ... Strategy Partners, LLP (IdSP) . Designed to fill a ... complex identity market, founding partners Mark Crego ... combined years just in identity expertise that span federal ... non-profit leadership. The Crego-Kephart combined expertise has a common ...
(Date:1/31/2017)... Jan. 31, 2017  Spero Therapeutics, LLC, a ... the treatment of bacterial infections, today announced it ... candidates from Pro Bono Bio Ltd (PBB) to ... multi-drug resistant forms of Gram-negative bacteria.   The assets ... Ltd, a PBB group company. "The ...
(Date:1/24/2017)... NEW YORK , Jan. 24, 2017 /PRNewswire/ ... market study of the laboratory use of nuclear ... of 363 experienced end-users and profiled current practices, ... three years, as well as growth and opportunities. ... NMR, Instrument suppliers, NMR instruments, needs and innovation ...
Breaking Biology News(10 mins):