Pfizer Documents (PHMPT/FDA)
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Pharmaceutical Sciences Reference Standard CertificateWorldwide Research & Development STANDARD INFORMATION Compound Reference Standard Lot Reevaluation / Expiration Date Occupational Exposure Band OEB 404-MA Y-2023677365P-1G-A-010REF_STD_GENERIC Long Term Storage Condition °C Short Term Storage Condition N/A Authorized By Authorized On 07-Jul-2021Primary Contact TESTS AND RESULTS Purity Purity FOOTNOTES DSPC: Storage at C Single use aliquot! 677365P-1G-A-010 Material is hygroscopic …
Pfizer Documents (PHMPT/FDA)
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Pharmaceutical Sciences Reference Standard CertificateWorldwide Research & Development STANDARD INFORMATION Compound Reference Standard Lot Reevaluation Date Occupational Exposure Band OEB 404-NOV-2021677315O-1G-A-010REF_STD_GENERIC Long Term Storage Condition °C Short Term Storage Condition N/A Authorized By Authorized On 13-May-2021 TESTS AND RESULTS Purity Purity FOOTNOTES ALC-0315: Storage at C Per vendor, material can only undergo and should be discarded after lot 677315O-1G-A-010…
Pfizer Documents (PHMPT/FDA)
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Pharmaceutical Sciences Reference Standard CertificateWorldwide Research & Development STANDARD INFORMATION Compound Reference Standard Lot Reevaluation / Expiration Date Occupational Exposure Band OEB 425-NOV-2021677159P-1G-A-010REF_STD_GENERIC Long Term Storage Condition °C Short Term Storage Condition N/A Authorized By Authorized On 01-Jul-2021Primary Contact TESTS AND RESULTS Purity Purity FOOTNOTES ALC-0159: Storage at C Single use aliquot! (reference for vialing protocol & …
Pfizer Documents (PHMPT/FDA)
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Pharmaceutical Sciences Reference Standard CertificateWorldwide Research & Development STANDARD INFORMATION Compound Reference Standard Lot Reevaluation / Expiration Date Occupational Exposure Band OEB 407-FEB-2025677100P-1G-A-010REF_STD_GENERIC Long Term Storage Condition °C Short Term Storage Condition N/A Authorized By Authorized On 07-Jul-2021Primary Contact TESTS AND RESULTS Purity Purity FOOTNOTES Cholesterol: Storage at C Single use aliquot! 677100P-1G-A-010 Material is hygroscopic …
Pfizer Documents (PHMPT/FDA)
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Pharmaceutical Sciences Worldwide Research & Development Certificate of Analysis Material Type: Material Description or Name: Material ID: Pfizer Lot Number: DS-001477PF-07305885 Drug SubstanceActive Pharmaceutical Ingredient 21Y513C2501 Authorized By 09-Feb-2021 REGISTERED TESTS ACCEPTANCE CRITERIA RESUL T Appearance (Clarity) Clarity Appearance (Coloration) Coloration pH UV Spectroscopy Content (RNA Concentration) RT-PCR Identity of Encoded RNA Sequence Capillary Gel Electrophoresis RNA…
Pfizer Documents (PHMPT/FDA)
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Pharmaceutical Sciences Worldwide Research & Development Certificate of Analysis Material Type: Material Description or Name: Material ID: Pfizer Lot Number: DS-001477PF-07305885 Drug SubstanceActive Pharmaceutical Ingredient 21Y513C2401 Authorized By 09-Feb-2021 REGISTERED TESTS ACCEPTANCE CRITERIA RESUL T Appearance (Clarity) Clarity Appearance (Coloration) Coloration pH UV Spectroscopy Content (RNA Concentration) RT-PCR Identity of Encoded RNA Sequence Capillary Gel Electrophoresis RNA…
Pfizer Documents (PHMPT/FDA)
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Pharmaceutical Sciences Worldwide Research & Development Certificate of Analysis Material Type: Material Description or Name: Material ID: Pfizer Lot Number: DS-001477PF-07305885 Drug SubstanceActive Pharmaceutical Ingredient 21Y513C2301 Authorized By 10-Feb-2021 REGISTERED TESTS ACCEPTANCE CRITERIA RESUL T Appearance (Clarity) Clarity Appearance (Coloration) Coloration pH UV Spectroscopy Content (RNA Concentration) RT-PCR Identity of Encoded RNA Sequence Capillary Gel Electrophoresis RNA…
Pfizer Documents (PHMPT/FDA)
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COVID -19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Response to 25Jun2021 F DA IR Re: LRP template IR for STN 125742/0 PFIZER CONFIDENTIAL Page 1LRP TEMPLATE FOR STN 125742/0: QUERY 1: Please submit a lot release protocol template for COVID -19 mRNA Vaccine for CBER review b y COB Friday , July 9, 2021. Please include the assay s performed and acceptance criteria for the drug product. RESPONSE 1 The Lot release protocol that included the assay s performed and acceptance criteria was …
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc . 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 09July 2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
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COVID-19 Vaccine (BNT162, PF -07302048) BLA 125742/0 Module 1.11.1 Response to 20 May 2021 F DA IR–Manufacturing Schedules & Precautions PFIZER CONFIDENTIAL Page 1QUERY 1 Please submit an updated manufacturing schedule for June 1 through October 31, 2021, that details upstream and downstream operations for BNT162b2 drug substance manufacturing in both and at Wy eth BioPharma Division of WyethPharmaceuticals LLC facility(FEI: 1222181) in Andover, MA in support of BLA 125742/0. RESPONSE 1…
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 24May2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Pfizer Documents (PHMPT/FDA)
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Pfizer Global Regulatory Affairs Pfizer Inc. 400 Arcola Road Collegeville, PA 19426 Global Product Developm ent 20July2021 Marion Gruber, Ph.D. Director Office of Vaccines Research and Review Food and Drug Administration Center for Bi ologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue WO71, G112 Silver Spring, MD 20993 -0002THIS DOCUMENT CONTAINS CONFIDENTIAL AND/OR TRADE S ECRET INFORMATION THAT IS DISCLOSED ONLY IN CONNECTION WITH THE LICENSING AND/OR …
Pfizer Documents (PHMPT/FDA)
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Pharmaceutical Sciences Reference Standard CertificateW orldwide Research & Development ST ANDARD INFORMATION Compound Reference Standard Lot Reevaluation / Expiration Date Occupational Exposure Band OEB 505-AUG-2021PF-07302048-DP-RMPF-07302048 Long T erm Storage Condition °C Short Term Storage Condition N/A Authorized By Authorized On 01-Feb-2021Rebekah WardPrimary Contact TESTS AND RESULTS Fluorescence assay mg/mL RNA Content FOOTNOTES Parent drug product lot C for up to days if sampled…
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BNT162b2 3.2.S.4.2 Analytical Procedures Overvie w PFIZER CONF IDEN TIAL Page 13.2.S.4.2. OVERVIEW Analy tical procedures for the control of BNT162b2 drug substance , are presented in this section ,as listed in Table 3.2.S.4.2-1 andTable 3.2.S.4.2-2. As requested b y FDA, the anal ytical standa rd operating procedures are presented in Section 3.2.R Standard Operating Procedure s, Method Validation and Transfer Repo rts. 090177e197030c1b\Approved\Approved On: 12-May-2021 06:05 (GMT) …
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Yu-Hua Tseng · JOSLIN DIABETES CENTER · 2021 · $606,855 — Project Summary/Abstract Obesity is growing at epidemic rates worldwide and leads to a broad spectrum of other disorders, which collectively form metabolic syndrome. Central to these pathologies is the adipose tissue. In mammals, there are two functionally distinct types of fat: white adipose tissu…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Forrest M Kievit · UNIVERSITY OF NEBRASKA LINCOLN · 2021 · $446,587 — PROJECT SUMMARY/ABSTRACT Traumatic brain injury (TBI) is the leading cause of disability and death in people under 45 with approximately 10 million new cases each year worldwide. The effects of TBI can be severe, including neurocognitive, physical, and psychosocial impairment. There remains a signi…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Marco E Zamora · DREXEL UNIVERSITY · 2021 · $46,036 — Proposal Summary/Abstract Acute respiratory distress syndrome (ARDS) is an acute inflammation of the lungs. It represents 10% of all intensive care unit (ICU) admissions in the United States. Despite decades of research and numerous large clinical trials, there are few treatments for ARDS. This lack…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Nathan Claude Gianneschi · NORTHWESTERN UNIVERSITY AT CHICAGO · 2021 · $398,137 — Project Summary The Polymeric Materials Synthesis and Characterizations Core will formulate, synthesize, and characterize lead candidates for the mitigation of mustards and provide support and chemical expertise to other cores and projects. The Core will be co-directed by Drs. Nathan Gianneschi (Dep…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
Thomas William Geisbert · UNIVERSITY OF TEXAS MED BR GALVESTON · 2021 · $770,799 — PROJECT SUMMARY - Research Project 3 Members of the filovirus genera Ebolavirus and Marburgvirus are HHS Tier 1 Category A priority pathogens that cause severe and often fatal hemorrhagic fever (HF) in humans and nonhuman primates (NHPs). There are presently no approved therapeutics for ebolavirus o…
NIH Pandemic-Era Grants
· Pandemic Era Grants
/ 2021
THOMAS HASSELL · INTERNATIONAL AIDS VACCINE INITIATIVE · 2021 · $1,595,794 — NIAID Process Development and Analytical Support for Development of HIV Vaccines: The development of vaccines to prevent the spread of HIV infection is among the National Institute of Allergy and Infectious Diseases (NIAID) highest priorities. While advances in immunology and molecular biology conti…