Viral Vaccines are required to under go multi stage testing with a variety of different assays is used to assure product safety and ensure product quality. This includes testing all the biological materials in vaccine manufacture, especially the initial components, which are the virus seed and the cell substrate. Different stages for testing are selected based on the maximum likelihood of adventitious agent detection and effect on product quality. a table shown below is a typical testing scheme; actual selected tests will depend upon the actual cell substrate, the product, and its manufacture. Additional tests may be included on a case-by-case basis depending upon the cell substrate and other biological materials as well as production conditions for vaccine manufacture.
Monday, August 2, 2010
Multi Stage Testing In Viral Vaccines During Production
Viral Vaccines are required to under go multi stage testing with a variety of different assays is used to assure product safety and ensure product quality. This includes testing all the biological materials in vaccine manufacture, especially the initial components, which are the virus seed and the cell substrate. Different stages for testing are selected based on the maximum likelihood of adventitious agent detection and effect on product quality. a table shown below is a typical testing scheme; actual selected tests will depend upon the actual cell substrate, the product, and its manufacture. Additional tests may be included on a case-by-case basis depending upon the cell substrate and other biological materials as well as production conditions for vaccine manufacture.
Latest Pharma Update
USFDA approves first drug Inmazeb to treat Ebola Virus Infection
US FDA approved first drug to treat Ebola Virus Infection (zaire ebolavirus) . So far there was no drug treatment available for Ebola virus ...


You May Also Like
-
Clean Room Classification aspects of cleanroom requirements in aseptic Process in manufacturing of sterile dosage form. Classification o...
-
Clean Room classification Pharmaceutical Manufacturing Area Classification particle count Introduction: Clean rooms are classified as per...
-
WHO GMP Training Questions and Answers Section for pharmaceutical manufacturing units :-Quality Management In this post i am giving some qu...
-
Pharmaceutical validation In pharmaceutical manufacturing industry Pharma Validation regulatory requirements. Validation in Pharma Indus...
-
Isolators in pharma manufacturing. What is an Isolator - A decontaminated unit, supplied with Class 100 (ISO 5) or higher air quality, th...

Pharmaceutical Manufacturing Guidelines
Reverse Osmosis Membrane Technology RO Water Purification system
SOP for Mechanical Qualification of Dissolution Apparatus
Standard Operating Procedure How to write a SOP
Sterile dosage form manufacturing facility inspection
Sterility testing in sterile dosage form
Sterility testing of Pharmaceuticals dosage forms
Transdermal Drug Delivery System
Ultraviolet light as antimicrobial disinfectant in water for pharmaceutical use
Monoclonal antibodies, Polyclonal Antibodies, What are Antibodies
What is a Biosimilar or Interchangeable Biopharmaceutical
What is clinical trial protocol
Common Technical Document(CTD)
What is drug receptors?How drug resistance occur
First pass metabolism of a drug
Lyophilization Freeze Drying advantages and disadvantages of lyophilization
What is a prion, What is Mad Cow Disease
What is protein binding of drug, Why a drug is bound to protein
What is protein binding of drug, Why a drug is bound to protein
Requirements Transdermal drug delivery system
Ophthalmic Preparation |Ophthalmic solution and suspensions
Monoclonal antibodies, Polyclonal Antibodies, What are Antibodies
GO TO TOP

No comments:
Post a Comment