Tag Archives: reference

  • WHO Ebola Vaccine Meeting

    … vaccination campaigns The meeting concluded that funding issues should not be allowed to dictate the vaccine agenda. The funds will be found.” *Check out the full article on WHO’s website.   For further technical information regarding the Ebola vaccine debate, reference Dr. Nigel J. Smart’s publication, Lean Biomanufacturing. His noteworthy publication provides a high-level understanding of the various scientific approaches that can be utilized within manufacturing processes of this …

  • Adult Stem Cells Show Potential for the Treatment of Cardiac Patients

    … point of reference for the advancement of these types of approaches. There are several advantages to mesenchymal stem cells as cell-based therapy; among these are: –    Can be taken from donors that are genetically different –    Are easy to prepare –    Tend to gather around injured spots It is certainly exciting to imagine what is ahead.  Each study will provide new information, new teachings, and new possibilities for the use of adult stem cell therapies to treat …

  • Be Prepared When the FDA Knocks on Your Door

    … that could attract the FDA’s attention before this happens.  Some examples are potential contamination, under maintenance, and unclean areas. 3. Select key people to accompany the FDA official Train two or more employees who supervise the major processes to follow the FDA official.  Teach them how to treat and interact with this person. 4.    Write an operations manual Operations manuals should be the main reference in the facility.  Employees must have continuous access to them in …

  • Ensuring QC for Laboratory Operations

    … ensure the product is free from contamination and deterioration.  reference material must be completely characterized and documented, well-stored, secured, and used during testing. 7.    The training All personnel must be highly-qualified and experienced to perform the job.  General as well as functional training must be validated.training should include a thorough knowledge of cGMP practices. 8.    The laboratory investigations These should identify the causes of a problem, and should …

  • Patent Holders, Watch Out!

    … biological product and the reference product would be expected in terms of safety, purity, and potency if treatment were to be initiated with the biological product instead of the reference product”.  HR 1548 requires that a follow-on biologic candidate exhibits biosimilarity “based upon data derived from: analytical studies that demonstrate that the biological product is highly similar to the reference product, from animal studies, and from clinical studies that are sufficient to …

  • Particle Size And Variability In Pharmaceutical Manufacturing

    … determined by manufacturing processes, so this subject is of great importance due to the order of magnitude of variability in particle size as determined by processes instead of, for instance, analyses for purity. It is interesting to look at typical manufacturing and analytical variability and how they affect the results of laser diffraction analyses. Milling, quality of unmilled product, different instrument vendors, homogeneity, reference materials – are all examples of factors that can …