Pfizer Central Research

Adi Treasurywala Pfizer Central Research, Groton, Connecticut, U.S.A. 

This work was partially supported by an International Research Scholarship from the Howard Hughes Medical Institute (to G.B.) and by a collaborative research grant from Pfizer Central Research (to G.B.). Digital Equipment Corporation generously loaned the Alpha workstations used for the calculations. Riccardo Destro kindly made the l-alanine diffraction data available to us. Thanks are also due to Mark Spackman, Carlo Gatti and Eric de La Fortelle for useful discussions. 

I express great appreciation to Drs. John Barrett and Paul McGuirk (Pfizer Central Research) and Dr. Linus Shen (Abbott Pharmaceutical Discovery) for their expert opinions, comments and suggestions concerning this review. 

HB thanks the EPSRC and Pfizer Central Research for a research studentship and research associateship (GR /K16296). Equipment used in this work was purchased with the aid of grants from the EPSRC and its pre-... 

B. J. BANKS, N. D. WALSHE and M. J. WITTY Pfizer Central Research, Sandwich... 

Pfizer Central Research Ltd., Sandwich, Kent CT13 9NJ, UK Dr R. L. Baxter... 

J. G. Slam, Pfizer Central Research, Groton. CT. http //ivww.ptizcr.cnm/ minn.html. Antibiotics 0-Lactamase Inhibitors... 

Pfizer Central Research, Sandwich, Kent CT13 9NJ, England. 

Arindam Bose Pfizer Central Research University of Michigan... 

N. D. A, Walshe, G. B. T. Goodwin, G. C. Smith, and F. E. Woodward, Pfizer Central Research, Sandwich, Kent CT13, 9NJ, England... 

Arindam Bose (Pfizer Central Research) further discussed the ICH documents and presented a rationale for the recommended combination of test procedures and process clearance validations required to demonstrate that marketed biopharmaceuticals are free of adventitious agents. He showed that testing of Pre-Seed Stock (PSS), the Master Cell Bank (MCB), and the Working Cell Bank (WCB) is required to demonstrate that they are free from contamination by mycoplasma, bacteria, molds, and yeasts. In addition, viral clearance validation studies must be performed on scaled down versions of each chromatographic step and the viral inactivation/removal step employed in the product purification scheme. Finally, clearance studies must be conducted with a panel of relevant and model viruses (typically three to four) to establish that the purification scheme will indeed purge any viruses that may be inadvertently introduced during processing. 

Thanks are due to the talented and dedicated scientists who made this research possible, and whose names appear in the references. Thanks are also due to the EPSRC, Merck Ltd., SmithKline Beecham (in particular Dr. Norman Lewis), Pfizer Central Research, and the University of Strathclyde for funding, and to the EPSRC National Mass Spectrometry Service for mass spectra. 

Pfizer Central Research SmithKline Beecham Pharmaceuticals Strem Chemicals UK... 

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