Cord Blood Licensure. Session 2C: Advanced Cell Therapies April 11, 2013
|
|
- Myra O’Brien’
- 8 years ago
- Views:
Transcription
1 Cord Blood Licensure Session 2C: Advanced Cell Therapies April 11, 2013
2 Objectives Describe rationale for cord blood licensure Cite licensure regulations Illustrate a case study of one program s pathway to obtaining licensure
3 FDA proposes draft regulatory approach for autologous & allogeneic UCB under IND leading to BLA Docket 96N-0002 Cord Blood Timeline of FDA s Proposed Regulation FDA announces Proposed Approach to Regulation of Cellular and Tissue-Based Products (Section 361 PHS Act) FDA requests Proposed Standards for Unrelated Allogeneic Peripheral and Placental/UCB HSCP Docket 97N-0497 FDA releases Draft UCB Guidance FDA releases Final UCB Guidance HCT/Ps Establishment Rule 21CFR 1271 Subparts A and B HCT/Ps Donor Suitability Rule 21CFR 1271 Subpart C Public meeting HCT/Ps cgtp Rule 21CFR 1271 Subparts D,E, and F Cord Blood Licensure Workshop, March 2010, Used with permission of Liana Harvath
4 Final FDA Guidance and Draft IND Documents were released Oct Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications Guidance for Industry and FDA Staff: Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications Within 2 years, all public CBBs must have completed the licensing process High profile process CB is one of the first cellular therapy products to undergo licensing process
5 FDA Regulation Due to the intended use in allogeneic recipients, CB is classified as a biologic drug CB is NOT a blood product or subject to blood rules CBB is NOT a blood bank or TM service Regulated under the more stringent biologic drug (Section 351, Part 1270) cgmp rules (Part 211) licensing and general biologics stds (Part 600, 601, 610) Processing is considered manufacturing CBBs are regulated like the pharmaceutical industry
6 Challenges When Applying cgmp to Cellular Therapies Biological variation of starting product Cells vs. chemicals Lot sizes Single patient lots vs. thousands of tablets Manufacturing Process Controls Many drugs can be terminally sterilized CT rely on aseptic processing Mechanism of action known TNC, CD34, CFU or other?
7 The St. Louis Cord Blood Bank Founded in 1995 by Donna Wall, MD First product banked Jan 1996 IND 7183 submitted Jun 30, 1997 Community program operates in collaboration with > 400 physicians at 29 local hospitals Public cord blood bank 127,000 donations; 28,000 processed 2,250 distributed to 34 countries, >20% international Affiliated with National Marrow Donor Program Member of National Cord Blood Inventory (NCBI) DOD s Radiation Injury Treatment Network (RITN)
8 To BLA or not to BLA
9 Pre-BLA meeting
10 Pre-Submission Activities Pre-BLA Meeting Purpose To uncover any major unresolved problems To identify those studies that the sponsor is relying on to establish the drug s effectiveness To acquaint FDA reviewers with the general information to be submitted in the marketing application (including technical information) To discuss appropriate methods for statistical analysis of the data To discuss the best approach to the presentation and formatting of data in the marketing application Lori Tull, FDA Cord Blood Licensure Workshop, March 2010
11 SLCBB Pre-BLA Meeting Timeline Means of directly contacting the agency Organize ourselves, summarize issues, propose questions April SLCBB request May FDA response May SLCBB submitted meeting package June FDA response to questions June face to face meeting in Rockville July FDA minutes
12 Strict cgmp Control & documentation of manufacturing process PLUS equipment qualification, PM, change control Cleaning procedures & disinfecting agents Doesn t specify facility configuration Closed system validation Justification for lack of classification Environmental monitoring for each lot undergoing processing
13 Reagents / Containers Reagent release Raw material qualification Critical identity and quality testing to be repeated, even with a Certificate of Analysis Containers and closures assess supplier s data and its applicability to your product and process Biocompatibility Toxicity Biological tests
14 Clinical Data Clinical safety data Summary of safety experience Narrative of adverse events Details of clinical outcome analyses Specify diagnoses for which product is indicated Provide evidence of efficacy for each additional diagnosis
15 Miscellaneous Reserve samples & attached segments Stability data to support expiration date Containers Storage conditions Source and number of samples Over history Legacy Inventory
16 Assembling and Filing Application
17 Preparation for Filing Formed Licensure Committee and meet weekly Understand the regs, translate pharma-speak Legacy inventory will not meet licensure requirements Confer with admins to ensure their support Align with mission Recognize need to be aggressive in making required changes; physical plant, environmental monitoring, technical policies, Quality Unit Lack expertise in commercialization Considered but rejected hiring consultants
18 Submission Application prep We re not ready! It s not perfect! Cease speculating Due diligence Oct : Submit application Contact review team Real dialoguing begins Dec : Application filed
19 The site visit
20 Site Visit April April Contract Manufacturing Site Preparation Inservices process, behavior Identified escorts, scribes & topic representatives Sign in sheets for attendance, document requests Assessment Opportunity Disruptive, create OT, reduces productivity Only some reviewers office continues requests
21 Don t underestimate Quality Unit Quality Management: Personnel, Equipment, EM, Document Control SOPs in new language Process Control Validation, Qualification and Audits Compliance with Regulation / Accreditation Review records to ensure that no errors have occurred and that those that do occur are fully investigated Responsible for approving/rejecting procedures/specifications affecting identity, strength, quality, and purity of drug product (HPCs) Alters authority of MD
22 Responses
23 Actions Facility segregation, lockers, upgrade HEPA filtration, positive pressure, pass through windows, PPE Micro lab, drafted validation plan Environmental Monitoring plan room classified Cleaning/Disinfection Plan housekeeping contractor Secure evidence of control with intent to scale back QCS Viable / non-viable particle counts equipment qualification process validation materiels mgmt reagent/supply conformance
24 Actions, cont d Collection & Process Validations Expected endpoints determined from historical experience & guidance Stability of cellular potency, component integrity, product sterility Define appropriate time period Define characteristics & endpoints Establishment of expiration date Loss of potency of active ingredient Label ISBT 128 vs NDC Fully implement, not just 16 digit number
25 Impact Making industry standard resin bottle (antibiotic neutralization) Pace with contract manufacturer Changes impact staff morale Productivity Jan-Jun 2010 = 23.5% Jan-Jun 2011 = 20% Jan-Apr 2012 = 17% (Apr = 14%) Cost creep
26 Approval!
27
28 Conclusions Don t take the process lightly The educational process is bi-directional Integrate with regular job Keep the goal in focus Saving lives everyday
29 Thank you & best wishes from St. Louis!
cgmp Challenges for Cord Blood Banks
cgmp Challenges for Cord Blood Banks Donna M. Regan, MT(ASCP)SBB St. Louis Cord Blood Bank @ SSM Cardinal Glennon Children s s Medical Center Cord Blood Bank processing facility challenges What does cgmp
More informationGuidance for Industry
Guidance for Industry Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies DRAFT GUIDANCE This
More informationGuidance for Industry and FDA Staff
Guidance for Industry and FDA Staff Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution
More informationThe Power & Potential of Cord Blood
The Power & Potential of Cord Blood Donna Regan, MT(ASCP)SBB, Director St. Louis Cord Blood Bank & Cellular Therapy Laboratory SSM Cardinal Glennon Children s Medical Center April 30, 2014 Objectives Since
More informationCord Blood Banking and Biologic License Application (BLA) November 19, 2010
Cord Blood Banking and Biologic License Application (BLA) November 19, 2010 1 Webinar Presenters Tara Sadeghi, BS University of Texas MD Anderson Cord Blood Bank Michele Carbone, MS, CLS, MT(ASCP)SH,DLM,CQM,
More informationGuidance for Industry
Guidance for Industry Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications Additional copies of this guidance are
More informationThe Power & Potential of Cord Blood
The Power & Potential of Cord Blood Donna Regan, MT(ASCP)SBB, Director St. Louis Cord Blood Bank & Cellular Therapy Laboratory SSM Cardinal Glennon Children s Medical Center September 18, 2013 Objectives
More informationLicensing Your Cord Blood
Licensing Your Cord Blood A Guide to Getting FDA Approval for Marketing your Public Bank s Lifesaving Product as a Prescription Drug 1.888.MEDIWARE Mediware.com Contents Introduction 1 Profits for Today,
More informationGuidance for Industry
Guidance for Industry Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients
More informationSummary of Advisory Council on Blood Stem Cell Transplantation: Recommendations and Status
of Advisory Council on Blood Stem Cell Transplantation: Recommendations and Shelley Grant Branch Chief, Blood Stem Cell Transplantation Program September 11, 2015 Overview December 20, 2005 - HRSA began
More informationUS Regulations for Import and Export of Cell Therapy Products
US Regulations for Import and Export of Cell Therapy Products Kurt Gunter, MD U Minnesota UCB Transplants (2001-2007)* Total units: 790 Number US banks: 19 Number non-us banks: 12 % units from non-us banks:
More information5th Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration. Summary of Changes
5th Edition NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration Summary of Changes This document summarizes the changes made to the 5th edition of the
More information[DOCKET NO.96N-0002] DRAFT
[DOCKET NO.96N-0002] DRAFT DRAFT DOCUMENT CONCERNING THE REGULATION OF PLACENTAL/UMBILICAL CORD BLOOD STEM CELL PRODUCTS INTENDED FOR TRANSPLANTATION OR FURTHER MANUFACTURE INTO INJECTABLE PRODUCTS DECEMBER,
More informationComparability of Cord Blood Units
Comparability of Cord Blood Units John D. McMannis,, Ph.D. Professor of Cancer Medicine Director, Cell Therapy Laboratory Technical Director, UT MDAnderson Cord Blood Bank Liaison Meeting, Bethesda June
More informationCord Blood: Thawing & Infusion Practical Methods
Cord Blood: Thawing & Infusion Practical Methods Donna M Regan, MT(ASCP)SBB St. Louis Cord Blood Bank @ SSM Cardinal Glennon Children s s Medical Center Objectives Present variety of product configurations
More informationPACT Web Seminar July 19, 2007
PACT Web Seminar July 19, 2007 Phyllis I. Warkentin, MD Professor, Pathology and Pediatrics University of NE Medical Center Medical Director Chairman, Accreditation Program Foundation for the Accreditation
More informationDocument Review: Centers for Medicare and Medical Service (CMS) What Do I Need to Do to Assess Personnel Competency?
Document Review: Centers for Medicare and Medical Service (CMS) What Do I Need to Do to Assess Personnel Competency? http://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/clia_compbrochure_508.pdf
More informationFiscal Year 2013 Annual Progress Report on the C.W. Bill Young Cell Transplantation Program and National Cord Blood Inventory Program
U.S. Department of Health and Human Services Fiscal Year 2013 Annual Progress Report on the C.W. Bill Young Cell Transplantation Program and National Cord Blood Inventory Program Executive Summary The
More informationResponse to Public Comments for the 7 th edition of Standards for Cellular Therapy Services
Please note that public comments that were submitted address the proposed Standards. The changes are best understood when the proposed Standards is compared to the final published version. The program
More informationTable of Contents. FACT Quality Handbook, Second Edition. Table of Contents
Table of Contents INTRODUCTION... i ACKNOWLEDGEMENTS... ii 1. Quality Management Program Overview... 1 Diagram of Quality Program Elements... 9 Sample Quality Management Performance Summary: Colorado Blood
More informationLe norme internazionali NetCord-FACT: linee guida per la qualità nel bancaggio del sangue cordonale
Le norme internazionali NetCord-FACT: linee guida per la qualità nel bancaggio del sangue cordonale Topics 1- NetCord-FACT: l organizzazione internazionale ed il suo scopo 2- Le norme di qualità sul bancaggio
More informationHematopoietic stem and progenitor cell transplants: regulation and accreditation
Pediatr Transplantation 2003: 7 (Suppl. 3): 101 108 Printed in UK. All rights reserved Copyright Ó 2003 Blackwell Munksgaard Pediatric Transplantation ISSN 1398-2265 Hematopoietic stem and progenitor cell
More informationCorporate Medical Policy Cord Blood as a Source of Stem Cells
Corporate Medical Policy Cord Blood as a Source of Stem Cells File Name: Origination: Last CAP Review: Next CAP Review: Last Review cord_blood_as_a_source_of_stem_cells 2/2001 3/2015 3/2016 3/2015 Description
More informationGuidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments
More informationCMC Writing for IND Applications. David H. McKenna, Jr., M.D. University of Minnesota April 10-11, 2007 Workshop
CMC Writing for IND Applications David H. McKenna, Jr., M.D. University of Minnesota April 10-11, 2007 Workshop CMC Writing for IND Applications ~Outline~ What is the CMC section? Who writes the CMC section?
More informationCorporate Medical Policy Cord Blood as a Source of Stem Cells
Corporate Medical Policy Cord Blood as a Source of Stem Cells File Name: Origination: Last CAP Review: Next CAP Review: Last Review cord_blood_as_a_source_of_stem_cells 2/2001 3/2015 3/2016 3/2015 Description
More informationGuidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
Reprinted from FDA s website by EAS Consulting Group, LLC Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products DRAFT GUIDANCE This guidance document
More informationHow To Run A Cord Blood Bank
INTERNATIONAL STANDARDS FOR CORD BLOOD COLLECTION, BANKING, AND RELEASE FOR ADMINISTRATION ACCREDITATION MANUAL Fifth Edition DRAFT September 2012 NOTICE These Standards are designed to provide minimum
More informationGuidance for Industry
Guidance for Industry Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages FINAL GUIDANCE U.S. Department of Health and Human Services Food
More informationProduct Complaint Form Instructions
Product Complaint Form Instructions Note: Product Complaint Definition: Failure/possible failure of a drug (includes biological products) to meet any of its specifications. This includes complaints that
More informationHematopoiesis i starts from. HPC differentiates t to sequentially more mature. HPC circulate in very low
Upstate Cord Blood Bank Hematopoietic Progenitor Cells Hematopoiesis i starts from self renewing HPC HPC differentiates t to sequentially more mature blood cells HPC circulate in very low numbers in adults
More informationUnique Device Identification System: Small Entity Compliance Guide Guidance for Industry and Food and Drug Administration Staff
Unique Device Identification System: Small Entity Compliance Guide Guidance for Industry and Food and Drug Administration Staff Document issued on August 13, 2014 On November 5, 2014 this document was
More informationJennifer Collins, RN Quality Liaison Ann & Robert H. Lurie Children's Hospital of Chicago
Jennifer Collins, RN Quality Liaison Ann & Robert H. Lurie Children's Hospital of Chicago General points of interest Facility Personnel Quality Management Policies & Procedures Donor Evaluation and Management
More informationCellular Therapy Liaison Meeting 10 September 2009 BECS. M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB
Cellular Therapy Liaison Meeting 10 September 2009 BECS M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB Definition from October 2007 draft guidance BECS Validation In the User s Facility
More informationU.S. Department of Health and Human Services Advisory Council on Blood Stem Cell Transplantation (ACBSCT) January 28-29, 2008 Rockville, MD
January 28, 2008 U.S. Department of Health and Human Services January 28-29, 2008 Rockville, MD After all of the council members were sworn in, they returned to the meeting room. Welcome Health Resources
More informationEconomics of Cord Blood Banking. Michael Boo NMDP Be The Match September 11, 2015
Economics of Cord Blood Banking Michael Boo NMDP Be The Match September 11, 2015 Historical Use UCB Use Data 2 NMDP Historical Transplants by Product 7,000 6,500 6,000 5,500 5,000 4,500 4,000 3,500 3,000
More informationGuidance for Industry
Guidance for Industry Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container This guidance is for immediate implementation. FDA is issuing this guidance for immediate
More informationCord Blood Advisory Group: Organization and Highlights (from November 2013 meeting)
Cord Blood Advisory Group: Organization and Highlights (from November 2013 meeting) Presented to the AABB Center for Cellular Therapies Cord Blood subsection by Merry Duffy Director, Cord Blood Operations,
More informationU.S. Department of Health and Human Services. Are Distributed to Cord Blood Banks Participating In the National Cord Blood Inventory.
U.S. Department of Health and Human Services Interim DRAFT: Report DO to NOT Congress CIRCULATE on How Federal Funds Are Distributed to Cord Blood Banks Participating In the National Cord Blood Inventory
More informationPreparation of cord blood for infusion: bedside thaw, dilute and wash, or somewhere in between
Preparation of cord blood for infusion: bedside thaw, dilute and wash, or somewhere in between Donna Wall, MD Director, Manitoba Blood and Marrow Transplant Program ISCT 2012 Disclosures: none The problem:
More informationPreparing for the Pre-Approval Inspection What to do Before the FDA Arrives. Barry A. Friedman, Ph.D. Consultant
Preparing for the Pre-Approval Inspection What to do Before the FDA Arrives Barry A. Friedman, Ph.D. Consultant FDA Overview FDA is a consumer protection agency within the Department of Health & Human
More informationUMBILICAL CORD BLOOD HARVESTING & STORAGE
Protocol: TRP009 Effective Date: October 14, 2013 UMBILICAL CORD BLOOD HARVESTING & STORAGE Table of Contents Page COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE... 1 BACKGROUND... 2 CLINICAL EVIDENCE...
More information15350 Sherman Way, Suite 350 Van Nuys, CA 91406 Phone 877-310-0717 Fax 818-251-5300 www.hemacare.com. April 17, 2015.
15350 Sherman Way, Suite 350 Van Nuys, CA 91406 Phone 877-310-0717 Fax 818-251-5300 www.hemacare.com April 17, 2015 Dear Shareholder, We are experiencing exciting times at HemaCare. Over the course of
More informationEstablishing a Cord Blood Bank in a Regional Blood Center. Kristy Unold, MT(ASCP)SBB, CQA(ASQ) Amy Lambert, MM, BSChE
Establishing a Cord Blood Bank in a Regional Blood Center Kristy Unold, MT(ASCP)SBB, CQA(ASQ) Amy Lambert, MM, BSChE Our Regional Blood Center *260,000 blood components collected in calendar year 2011
More informationThe Role of the Laboratory in Clinical Trials. Basma Elgamal, M.D. Professor of Clinical Pathology National Cancer Institute, Cairo University
The Role of the Laboratory in Clinical Trials Basma Elgamal, M.D. Professor of Clinical Pathology National Cancer Institute, Cairo University Laboratory role in CT Laboratory can play within a clinical
More informationProgram Report to the Advisory Council on Blood Stem Cell Transplantation. Shelley Grant September 11, 2015
Program Report to the Advisory Council on Blood Stem Cell Transplantation Shelley Grant September 11, 2015 Presentation Overview Review legislative authority for Stem Cell Therapeutic and Research Reauthorization
More informationSTEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005
STEM CELL THERAPEUTIC AND RESEARCH ACT OF 2005 VerDate 14-DEC-2004 06:53 Jan 05, 2006 Jkt 039139 PO 00000 Frm 00001 Fmt 6579 Sfmt 6579 E:\PUBLAW\PUBL129.109 APPS10 PsN: PUBL129 119 STAT. 2550 PUBLIC LAW
More informationGuidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations
Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)
More informationDesign, Operation and Management of GTP/GMP Cell Engineering Facilities
Design, Operation and Management of GTP/GMP Cell Engineering Facilities Scott R. Burger, MD Advanced Cell & Gene Therapy BFDA 2007 International Symposium on Regulation of Human Cell and Tissue- Based
More informationTransmedcon 2014. Ahmedabad, Gujarat November 14-16, 2014
FACT Accreditation for Cord Blood Banks and Cellular Therapy Nadim Mahmud, MD, PhD Associate Professor of Medicine Division of Hematology/Oncology Director, Hospital Stem Cell Laboratory Blood & Marrow
More informationCleveland Cord Blood Center Biologics License Application (BLA) Mary J. Laughlin, MD Medical Director
Cleveland Cord Blood Center Biologics License Application (BLA) Mary J. Laughlin, MD Medical Director Background: Cleveland Cord Blood Center A non-profit public cord blood bank. Established in 2007 with
More informationGuidance for Industry
Reprinted from FDA s website by EAS Consulting Group, LLC Guidance for Industry Providing Regulatory Submissions in Electronic Format Standardized Study Data DRAFT GUIDANCE This guidance document is being
More informationMeriCal Quality Profile
January 5, 2015 Dear Valued Customer, Since the implementation of new federal regulations, MeriCal Inc. has received a large volume of questionnaires and surveys regarding our services and procedures.
More informationCHAPTER 7 QUALITY ASSESSMENT
CHAPTER 7 QUALITY ASSESSMENT Chapter 7 QUALITY ASSESSMENT 7.1 OVERVIEW OF CBB-SPECIFIC QUALITY ASSURANCE/QUALITY CONTROL PROGRAM An extensive, site-specific Quality Assurance/Quality Control (QA/QC) program
More information14.0 Stem Cell Laboratory Services
Laboratory Services Contact Information: To inquire about assisting with surgical harvesting of bone marrow, cellular therapy (CT) product processing, cryopreservation, storage, or any other lab services,
More informationRegulatory Pathways for Licensure and Use of Ebola Virus Vaccines During the Current Outbreak FDA Perspective
Regulatory Pathways for Licensure and Use of Ebola Virus Vaccines During the Current Outbreak FDA Perspective Office of Vaccines Research and Review Center for Biologics Evaluation and Research U.S. Food
More informationProviding Regulatory Submissions In Electronic Format Standardized Study Data
Providing Regulatory Submissions In Electronic Format Standardized Study Data Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation
More informationImproving Quality in Cellular Therapy with FACT Accreditation. The Foundation for the Accreditation of Cellular Therapy
Improving Quality in Cellular Therapy with FACT Accreditation The Foundation for the Accreditation of Cellular Therapy 1 Goals and Services of FACT Promote quality patient care and laboratory practice
More informationUse of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors
This document is scheduled to be published in the Federal Register on 01/08/2016 and available online at http://federalregister.gov/a/2016-00149, and on FDsys.gov 4164-01-P DEPARTMENT OF HEALTH AND HUMAN
More informationGuidance for Industry Bar Code Label Requirements Questions and Answers
Guidance for Industry Bar Code Label Requirements Questions and Answers For questions on the content of this guidance, contact the Center for Drug Evaluation and Research or the Center for Biologics Evaluation
More informationCombination Products. Presented by: Karen S. Ginsbury For: IFF March 2014. PCI Pharma
Combination Products Presented by: Karen S. Ginsbury For: IFF March 2014 Types of products Biological and medical device (freeze dried + syringe dual volume) Medical device and plasma devised product (syringe)
More informationThe Cord Blood Industry and Be The Match
The Cord Blood Industry and Be The Match Arthur Busse Manager of Business Analytics NMDP: Be The Match Sept. 11, 2015 Be The Match Mission Saving Lives with cellular therapy through science, service and
More informationQuality Agreement. by and between. Supplier Name. Address: and. Client Name: Address:
NOTE TO USERS This Quality Agreement template was developed by the Bulk Pharmaceutical Task Force (BPTF), an affiliate organization of the Society of Chemical Manufacturers and Affiliates (SOCMA), as a
More informationCombination Products Regulation in the United States
Combination Products Regulation in the United States Presenter: Scott Sardeson RAC US/EU 3M Health Care St. Paul, MN USA 1 Presentation Outline Combination products Definitions and Regulations Jurisdiction
More informationENVIRONMENTAL TESTING & MONITORING: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers A WHITE PAPER
A WHITE PAPER ENVIRONMENTAL TESTING & MONITORING: Deciphering Compliance Requirements for Pharmaceutical and Medical Device Manufacturers By Scott Mackin A WHITE PAPER ENVIRONMENTAL TESTING & MONITORING:
More informationMicrobiology and Auditing. Don Singer
Microbiology and Auditing Don Singer ASQ Northeast Pharmaceutical GMP/Quality Conference 2011 Through the eyes of a Microbiologist Microbiology Audit = Inspection / Investigation Systematic Auditing Planning
More informationUS Perspective on the Regulatory Assessment of Benefit-Risk of Vaccines
US Perspective on the Regulatory Assessment of Benefit-Risk of Vaccines Norman W. Baylor Biologics Consulting Group, Inc. 23-25 June 2014 Foundation Merieux Conference Center OUTLINE OF PRESENTATION Introduction
More informationGuidance for Industry Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
Guidance for Industry Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products U.S. Department of Health and Human Services Food and Drug Administration
More informationCord Blood for Cellular Therapy: A Snapshot of this Evolving Market Landscape
GENReports: Market & Tech Analysis Cord Blood for Cellular Therapy: A Snapshot of this Evolving Market Landscape > Enal Razvi, Ph.D. Biotechnology Analyst, Managing Director SELECTBIO US enal@selectbio.us
More informationGLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com
GLP vs GMP vs GCP Dominique Pifat, Ph.D., MBA The Biologics Consulting Group dpifat@bcg-usa.com Common Misconception Good Laboratory Practices 1) A quality system concerned with the organizational process
More informationThe purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers.
Supplier Quality Standard 1.0 Purpose The purpose of this Supplier Quality Standard is to communicate the expectations and requirements of Baxter Healthcare Corporation to its suppliers. These expectations
More informationMaking SOP Training More Effective
By David Peterson, Director, GMP and Quality Systems, UL EduNeering SOPs are critical to efficient operations, quality control and regulatory compliance. This paper reviews best practices for the Life
More informationRisk-Based Environmental Monitoring. Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI
Risk-Based Environmental Monitoring Marsha Stabler Hardiman Senior Consultant Concordia ValSource Wednesday September 17, 2014 FDA/PQRI Presenter Marsha Stabler Hardiman Over 20 years experience in the
More informationA Cure for Sickle Cell Anemia and Thalassemia
IV Simpósio Internacional de Hemoglobinopatias A Cure for Sickle Cell Anemia and Thalassemia Bertram Lubin, MD and Mark Walters, MD 4 September 2007 Topics to be covered Cord blood: Importance and biology
More informationCLIENT AGREEMENT. Copyright 2014 MiracleCord Inc. All rights reserved.
CLIENT AGREEMENT MiracleCord, Inc. is a provider of services for the collecting, testing, processing, cryopreserving and storing of cells collected from a newbornʼs umbilical cord blood ( Cord Blood )
More informationINFORMATION ON STEM CELLS/BONE MARROW AND REINFUSION/TRANSPLANTATION SUR703.002
INFORMATION ON STEM CELLS/BONE MARROW AND REINFUSION/TRANSPLANTATION SUR703.002 COVERAGE: SPECIAL COMMENT ON POLICY REVIEW: Due to the complexity of the Peripheral and Bone Marrow Stem Cell Transplantation
More informationUniversity of Colorado Hospital Policy and Procedure Transplant and Implant Tissue Storage and Issuance
University of Colorado Hospital Policy and Procedure Transplant and Implant Tissue Storage and Issuance Related Policies and Procedures: Temperature Controlled Storage Unit Monitoring Hospital Infection
More informationManufacturing Cellular Products for International Clinical Trials
Manufacturing Cellular Products for International Clinical Trials Q U A L I T Y A N D O P E R A T I O N S T R A C K 7 4 / 2 5 / 1 4 1 3 : 4 5-1 5 : 1 5 Olive J Sturtevant, MHP,MT (ASCP)SBB, CQA Director
More informationBlood, Plasma, and Cellular Blood Components INTRODUCTION
Blood, Plasma, and Cellular Blood Components INTRODUCTION This chapter of the Guideline provides recommendations to Sponsors of Requests for Revision for new monographs for blood, plasma, and cellular
More informationPresented by Rosemarie Bell 24 April 2014
Global Good Manufacturing Practice A Comparability Study to Link Good Manufacturing Practice Standards for World Wide Compliance Within the Cellular Therapy Industry Presented by Rosemarie Bell 24 April
More informationGAO NATIONAL CORD BLOOD INVENTORY. Practices for Increasing Availability for Transplants and Related Challenges. Report to Congressional Committees
GAO United States Government Accountability Office Report to Congressional Committees October 2011 NATIONAL CORD BLOOD INVENTORY Practices for Increasing Availability for Transplants and Related Challenges
More informationThe FDA recently announced a significant
This article illustrates the risk analysis guidance discussed in GAMP 4. 5 By applying GAMP s risk analysis method to three generic classes of software systems, this article acts as both an introduction
More informationOneMatch National. Sue Smith, Executive Director, Stem Cells 2011-11- 04
OneMatch National Public Cord Blood Bank Blood Matters 2011 Sue Smith, Executive Director, Stem Cells 2011-11- 04 No Disclosures To Declare The presenter does not have any involvement with the industry
More informationcord blood saves lives...
cord blood saves lives... ...by providing a rich source of blood stem cells that can be used to treat over 80 different diseases including leukemia, lymphoma, thalassemia, Tay-Sachs and sickle cell anemia.
More informationDRAFT GUIDANCE. This guidance document is being distributed for comment purposes only.
Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Labeling and Advertising Materials for Human Prescription Drugs Guidance for Industry DRAFT GUIDANCE This guidance document
More informationRegulation and Risk Management of Combination Products
Regulation and Risk Management of Combination Products Katherine Ulman Associate Scientist Global Regulatory Compliance Manager Dow Corning Healthcare Jim Curtis Senior Specialist, Healthcare Applications
More informationBiosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 Guidance for Industry DRAFT GUIDANCE This guidance document is being
More informationSERVICES FOR. Devices and Combination Products
SERVICES FOR Devices and Combination Products How to Contact Us U.S. FACILITIES / CLIENT SERVICES St. Paul 2540 Executive Drive St. Paul, MN 55120 FAX 651.675.2005 Atlanta 1265 Kennestone Circle Marietta,
More informationCord Blood Stem Cell Transplantation
LEUKEMIA LYMPHOMA MYELOMA FACTS Cord Blood Stem Cell Transplantation No. 2 in a series providing the latest information on blood cancers Highlights Umbilical cord blood, like bone marrow and peripheral
More informationGuidance for Industry
Guidance for Industry Charging for Investigational Drugs Under an IND Qs & As DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this
More informationHow To Support Umbilical Cord Blood Stem Cell Research
Cauley O. Gieb Advanced Health Law HLP Article Umbilical Cord Blood Stem Cell Research: The Proof is in the Cord Today advances in science seem to gain the most recognition and support when the subject
More informationMilano Cord Blood Bank 18 year report on cord blood banking and transplant
Milano Cord Blood Bank 18 year report on cord blood banking and transplant Paolo Rebulla, MD Milano Cord Blood Bank Center of Transfusion Medicine, Cellular Therapy and Cryobiology Department of Regenerative
More informationPublic Cord Blood Bank
The The Public Cord Blood Bank Page 1 of 21 TABLE OF CONTENTS INTRODUCTION... 3 WHAT ARE GOOD MANUFACTURING PRACTICES?... 5 1 TOTAL QUALITY... 7 2 PREMISES... 8 3 EQUIPMENT AND MATERIAL... 9 4 PERSONNEL...
More informationINTERNATIONAL STANDARDS FOR CORD BLOOD COLLECTION, BANKING, AND RELEASE FOR ADMINISTRATION
INTERNATIONAL STANDARDS FOR CORD BLOOD COLLECTION, BANKING, AND RELEASE FOR ADMINISTRATION Fifth Edition DRAFT September 2012 NOTICE These Standards are designed to provide minimum guidelines for Cord
More information4. All cord blood banks should be subject to the same standards, regulations and accreditation requirements.
WMDA Policy Statement on the Utility of Autologous or Family Cord Blood Unit Storage The WMDA Board adopted this policy on 25 th of May 2006. Policy updated _April 2011 The Cord Blood Working Group and
More informationGuidance for Industry
Guidance for Industry Expanded Access to Investigational Drugs for Treatment Use Qs & As DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding
More informationMedical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Draft Guidance for Industry and Food and Drug Administration Staff DRAFT GUIDANCE This guidance document
More informationSummary Basis for Regulatory Action
Date: June 13, 2013 Summary Basis for Regulatory Action From: Mohammad Heidaran, Ph.D., Chair of the Review Committee BLA/ STN#: 125432 Applicant Name: LifeSouth Community Blood Centers, Inc. Date of Submission:
More informationRequest for Quality Metrics Guidance for Industry
Request for Quality Metrics Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be
More information