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 Manufact
'/>"/>

SOURCE Microtest
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:5/27/2015)... -- IGI Laboratories, Inc. (NYSE MKT: IG), a ... updated its full year 2015 financial guidance and business ... Updated Financial Guidance , Total revenues for ... expected to be between $7.0 and $8.0 million. The Company ... for the remainder of the year, and therefore expects ...
(Date:5/27/2015)... , May 27, 2015  Halozyme Therapeutics, Inc. (NASDAQ: ... a member of the Roche Group, announced today a ... for Ventana to ultimately commercialize, a companion diagnostic assay ... The Ventana assay will be used to ... – a chain of natural sugars distributed throughout human ...
(Date:5/27/2015)... 27, 2015 Encision Inc. (OTCQB:ECIA), a medical ... stray electrosurgical burns in minimally invasive surgery, today announced ... fiscal year ended March 31, 2015. The ... a quarterly net loss of $349 thousand, or $(0.03) ... $2.504 million for a net loss of $1.453 million, ...
Breaking Medicine Technology:IGI Laboratories Updates Business Outlook 2IGI Laboratories Updates Business Outlook 3Halozyme, Ventana Enter Into Global Agreement To Collaboratively Develop Companion Diagnostic For Cancer Treatment 2Halozyme, Ventana Enter Into Global Agreement To Collaboratively Develop Companion Diagnostic For Cancer Treatment 3Halozyme, Ventana Enter Into Global Agreement To Collaboratively Develop Companion Diagnostic For Cancer Treatment 4Halozyme, Ventana Enter Into Global Agreement To Collaboratively Develop Companion Diagnostic For Cancer Treatment 5Encision Reports Fourth Quarter And Fiscal Year 2015 Results 2Encision Reports Fourth Quarter And Fiscal Year 2015 Results 3Encision Reports Fourth Quarter And Fiscal Year 2015 Results 4Encision Reports Fourth Quarter And Fiscal Year 2015 Results 5Encision Reports Fourth Quarter And Fiscal Year 2015 Results 6
... 2011 Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX ... clinical and preclinical data highlighting the safety and efficacy ... New Phase 3 data on the ... after augmentation mammoplasty will be presented by Sergio Bergese, ...
... 5, 2011 Xlumena, Inc., a ... endoscopist and endoscopic surgeon, announced today that it ... AXIOS™ Stent and Delivery System (AXIOS). The AXIOS ... translumenal therapy and is indicated for drainage of ...
Cached Medicine Technology:Pacira Pharmaceuticals, Inc. Announces EXPAREL™ Data Presentations 2Pacira Pharmaceuticals, Inc. Announces EXPAREL™ Data Presentations 3Pacira Pharmaceuticals, Inc. Announces EXPAREL™ Data Presentations 4Pacira Pharmaceuticals, Inc. Announces EXPAREL™ Data Presentations 5Xlumena Receives CE Mark for Revolutionary AXIOS™ Stent and Delivery System 2
(Date:5/27/2015)... May 27, 2015 SAN DIEGO, ... Gulfport Mississippi, is the first healthcare provider along ... to chronic care management (CCM). In partnership with ... is introducing RevUp, a new program that enables ... and increase monthly reimbursements. This new, user-friendly program ...
(Date:5/27/2015)... HOUSTON, Tx (PRWEB) May 27, 2015 ... combined germline pharmacogenomic and somatic genomic analysis in personalized ... was published by the American Society of Clinical Oncology ... – June 2 in Chicago. , The molecular and ... The Cancer Genome Atlas (TCGA) database. The study reports ...
(Date:5/27/2015)... On June 5, Plan B [the agency alternative], ... to host Donate Your Break, a public blood drive. ... donor coach outside of 116 W. Illinois (at LaSalle) ... whole blood units is highest for LifeSource, the largest ... requires approximately 1,000 donations per day to maintain an ...
(Date:5/27/2015)... 2015 This is a professional ... the Omega-3 industry. The report provides a basic ... and industry chain structure. The Omega-3 market analysis ... trends, competitive landscape analysis, and key regions development ... Fishing Company, Seadragon Marine Oils, Norwegian Fish Oil, ...
(Date:5/27/2015)... 2015 SonarMD, LLC, recently ... a first-of-its kind, cloud-based algorithmic process for ... chronic gastrointestinal disease. , Developed by noted ... allows physicians to monitor their patients’ health ... of electronic health assessment surveys. Using nationally ...
Breaking Medicine News(10 mins):Health News:Memorial Hospital Selects MD Revolution's Digital Health Platform to Deliver a New Form of Chronic Care Management 2Health News:Memorial Hospital Selects MD Revolution's Digital Health Platform to Deliver a New Form of Chronic Care Management 3Health News:CompanionDx® Analyzes Non-small Cell Lung Cancer Data for Personalized Cancer Therapy 2Health News:CompanionDx® Analyzes Non-small Cell Lung Cancer Data for Personalized Cancer Therapy 3Health News:Donate Your Break and Save Lives at the River North Blood Drive 2Health News:Omega-3 Market: Global 2015 Analysis & 2020 Forecasts on Market Size 2Health News:SonarMD™, LLC, Launches Game-Changing, IBD Population Health Management Platform 2
... Roger Seaver, president and CEO of Henry Mayo ... the Hospital Association of Southern California (HASC) for ... leading the board in developing public policies to ... and enhancing communication and consensus on public policy ...
... (UC) researchers have discovered that estrogen receptors are ... brain tumorleading them to believe that anti-estrogen drug ... and improving patients, overall outcome. , This research ... of Endocrinology . , In estrogen-responsive cancerssuch ...
... Marmot, chair of the World Health Organization Commission ... the International Institute for Society and Health at ... Health Lecture Series talk, "Social Determinants of Health: ... Lecture Series is organized by Martin Seligman, University ...
... 17 The Quantum Group, Inc. (NYSE Amex: ... PWeR(TM) (Personal Wellness electronic Record) demonstrations presented at the ... standing room only crowds throughout the 3-day event.Pete Martinez, ... Officer, led the team responsible for the development of ...
... Cross rolls out red carpet for one of its ... the most watched awards show on television, the American ... Barnes, Executive Director of the West Alabama Chapter in ... years ago in Vicksburg (MS). During his tenure with ...
... research? The National Institutes of Health (NIH) wants to ... March 4-6 on behalf of the NIH Office of ... research priorities for the next decade. The meeting begins ... health-care providers, patients, community groups, advocacy groups and other ...
Cached Medicine News:Health News:Henry Mayo CEO Elected Chairman of Hospital Association of Southern California 2Health News:Estrogen found to increase growth of the most common childhood brain tumor 2Health News:The Quantum Group Announces Standing-Room-Only PWeR(TM) Demonstrations at Pri-Med South Expo 2Health News:The Quantum Group Announces Standing-Room-Only PWeR(TM) Demonstrations at Pri-Med South Expo 3Health News:American Red Cross: Meet Our Oscar! 2Health News:American Red Cross: Meet Our Oscar! 3Health News:American Red Cross: Meet Our Oscar! 4Health News:WU hosts public hearing, conference to help NIH prioritize women's health research 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: