White Paper Explains Aspects of Testing From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product
Posted on: Tuesday, 24 February 2009, 09:20 CST
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
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
Available Topic Expert(s):
For information on the listed expert(s), click appropriate link.
https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622
SOURCE Microtest
Source: PR Newswire
Related Articles
- CEL-SCI Scientist Invited to Discuss Plans to Launch Unique Manufacturing Process That Saves Cost While Enhancing the Shelf Life of Drugs at 5th Annual Aseptic Processing of Sterile Drug Products Conference
- Microtest Labs Adds Dissolution Testing to its Suite of Analytical and Stability Testing Services
- Thomson Reuters Publishes Pharma Matters White Paper, 'The Five Myths of Generic Competition'
- Free White Papers Detail Sterility Testing Essentials for Medical Device, Pharmaceutical Manufacturers
- Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers
- New Free White Paper Addresses Challenges of New FDA Regulations Awaiting Combo Product Manufacturers
- Akesis Pharmaceuticals Manufactures Drug Product for Clinical Trials in Type 2 Diabetes
- Cosmetic Industry Releases Scientific White Paper on Use of Nanoparticles in Personal Care Products
- Antiviral Drug Supresses Deadly H5N1 Avian Flu in Animal Tests
 |
 |
User Comments (0)
RSS Feeds