thirteenth annual ifpac qbd/pat summit with induniv · 2016-09-02 · ifpac/pat/qbd summit with...

IFPAC/PAT/QbD Summit with INDUNIV

Thirteenth AnnualIFPAC® QbD/PAT Summit with INDUNIV

Manufacturing Quality for theBiopharmaceutical/Pharmaceutical Industries

June 21-22, 2016Isla Verde Beach Resort, Marriott Courtyard

Carolina, Puerto Ricowww.IFPACsummit.org

http://www.ifpac.com/IFPAC08/IFPAC07-02.jpg


http://www.ifpacsummit.org/


QbD/PAT Summit

INDUNIV Research Consortium is an organization promoting and providing the catalyst for effective collaboration towards knowledge creation amongst the life science industry, academia and government within Puerto Rico.

IFPAC is an international organization dedicated to the advancement and implementation of QbD/PAT.

IFPAC & INDUNIV


QbD/PAT Summit

• Krizia Karry, Ph.D., BMS• Xiaoyu Zhang, Ph.D., Eli Lilly• Rodolfo Romañach, Ph.D., UPR, Mayagüez, PR (Co-

Chairman)• Eric Sanchez, Ph.D., J&J• Manuel Hormaza, IBS Caribe• Carlos Conde-Reyes, Ph.D., Conde InduServices• Darlene Santiago, Ph.D., Torsten Stelzer, Ph.D., UPR, San

Juan, PR • Carlos Tollinche, Ph.D., INDUNIV• Robert S. Zutkis, IFPAC

ORGANIZING COMMITTEE


QbD/PAT Summit

• Rodolfo J. Romañach, Ph.D., UPR-M, Professor of Chemistry– Over 20 years of experience in vibrational spectroscopy, and

worked in Puerto Rico’s pharmaceutical industry for 12 years where he gained extensive experience in assay and cleaning validation, and in providing analytical support for API and pharmaceutical process related problems.

– Research efforts involve the development of NIR and Raman spectroscopic methods for pharmaceutical applications.

– A focus is placed on improving continuing education courses and strengthening industry/university interactions .

– Leads the Sensing project in the NSF Engineering Center for Structured Organic Particulate Systems. (http://ercforsops.org/)

University of Puerto Rico-Mayagüez, Department of Chemistry


QbD/PAT Summit

Background• A National Science Foundation Engineering Research

Center since 2006, Partner Institutions with Rutgers University include Purdue University, New Jersey Institute of Technology & University of Puerto Rico at Mayagüez.

• In the area of pharmaceutical science, the program contemplates several presentations from researchers in the NSF Engineering Research Center for Structured Organic Particulate Systems.

NSF-ENGINEERING RESEARCH CENTER FOR STRUCTURED ORGANIC PARTICULATE SYSTEMS


Overview of the Event

• FDA Regulatory Perspectives & Updates• Industry Case Studies / Lessons Learned • Innovative Solutions• The Latest Technologies• Vendor Overview Presentations• Numerous Networking Opportunities

– Daily Industrial Roundtables– Key Industry & Vendor Participants– Audience Participation Encouraged– Daily Receptions– Poster Sessions– Exhibits


FDA Updates

• Continuous Pharmaceutical Manufacturing: Scientific Considerations for Developing a Robust Manufacturing Process and Control Strategy – Arwa El Hagrasy, Ph.D., Chemist/Quality Assessment Lead (Acting),

FDA/CDER/OPF/OPQ, Silver Spring, MD

• Continuous Pharmaceutical Manufacturing: cGMP, Process Validation, and Inspectional Considerations for Implementation – Christina Capacci-Daniel, Ph.D., Consumer Safety Officer,

FDA/CDER/OPQ/OPF, Silver Spring, MD


Four Quadrant Approach

Day 1

• Quadrant I: Regulatory and Continuous Manufacturing • Quadrant II: Process Knowledge and Process

Monitoring Tools: How Process Knowledge and Process Monitoring Methods are used from Development through Release

Day 2

• Quadrant III: PAT & QbD Implementation: Biologicals • Quadrant IV: Pharmaceutical Engineering & Control

for PAT & QbD: Management of PAT Data


Quadrant IRegulatory and Continuous ManufacturingChair: Carlos A. Tollinche, Ph.D., INDUNIV

Day One - TuesdayMorning


Day One - Morning

• 9:00a.m. Welcome/Introduction – Carlos Tollinche, Ph.D., INDUNIV

• 9:15a.m. QbD Based Formulation and Process Development with Continuous Manufacturing Case Studies – Wyatt Roth, Eli Lilly and Company

• 9:55a.m. Continuous Pharmaceutical Manufacturing: Scientific Considerations for Developing a Robust Manufacturing Process and Control Strategy – Arwa El Hagrasy, Ph.D., Chemist/Quality Assessment Lead (Acting),

FDA/CDER/OPF/OPQ, Silver Spring, MD


Day One - MorningContinued…• 10:25a.m. Break

• 10:45a.m. Continuous Pharmaceutical Manufacturing: cGMP, Process Validation, and Inspectional Considerations for Implementation – Christina Capacci-Daniel, Ph.D., Consumer Safety Officer,

FDA/CDER/OPQ/OPF, Silver Spring, MD

• 11:15a.m. Emerging Regulatory Expectations for Continuous Solid Dose Pharmaceutical Manufacturing – Douglas B. Hausner, Ph.D., Associate Director, C-SOPS; Rutgers

University


Day One - MorningContinued…

• 11:45a.m. Transforming an Existing Batch Process to Continuous Process at Janssen Gurabo PR – Anthony Gonzalez, Janssen, Gurabo, PR

• 12:15p.m. Discussions and Recap – All Session Speakers

• 12:30p.m. Lunch


Quadrant IIProcess Knowledge and Process Monitoring Tools: How Process Knowledge and Process Monitoring

Methods are used from Development through Release Chair: Wyatt Roth, Ph.D., Eli Lilly

Day One - TuesdayAfternoon


Day One - Afternoon

• 1:30p.m. Independence or Dependence: A Discussion of FDA and EMA Guidelines for NIR Spectroscopic Procedures – Rodolfo Romañach, Ph.D., UPR, Mayagüez, PR

• 2:10p.m. Efficiency of Process Spectrum Methodology for Preparing the Calibration Set in NIR Pharmaceuticals Quality Control Analysis. An Innovation Tool for Process Analytical Technology – Vanessa Cardenas, Marcelo Blanco, Manel Alcala, Universitat

Autonoma de Barcelona, Spain


Day One - Afternoon• 2:40p.m. Characterizing a Drug Product Continuous

Manufacturing Platform’s Residence Time Distribution Using Major and Minor Unit Formula Excipient Step Changes and Soft Sensors – Leo Manley, Zhenqi Shi, Salvador García Muñoz and Ahmad Almaya,

Eli Lilly

• 3:10p.m. Break (POSTERS)

• 3:30p.m. Challenges in the Development of In-Line Calibration Models for Prediction of Low Drug Concentration Formulations within a Feed-Frame – Carlos Pinzon-De la Rosaa,c, Andrés D. Román-Ospinoa, Carlos

Ortega-Zúñigaa, Rafael Méndezb,c, Rodolfo J. Romañach, University of Puerto Rico, Mayaguez, PR


Day One - Afternoon• 4:00p.m. In-Process Wide Area Raman Spectroscopy for Real-

Time Monitoring of Critical Quality Attributes in Batch or Continuous Solid Dosage Manufacturing Operations – Sean Gilliam, Kaiser Optical Systems, Inc.

• 4:30p.m. Combining Spectroscopy and Critical Process Parameters for Monitoring Continuous Tablet Manufacturing via Multivariate Data Analysis – Heather Brooke, CAMO Software Inc., Savitha Panikar and Doug

Hausner, Rutgers University

• 5:00p.m. Hyperspectral Imaging Technology for Pharmaceutical Processing – Jagdish Tewari, Biogen, Cambridge, MA

• 5:30p.m. Close/Reception


Quadrant IIIPAT & QbD Implementation, BiologicalsChairs: Manuel Hormaza, IBS Caribe and Krizia Karry, Ph.D., BMS, Humacao, PR

Day Two - WednesdayMorning


Day 2 - Morning

• 9:00a.m. Raman Chemometric Model Development for Continuous Process Monitoring of Constituents in a CHO Cell Culture Fed-batch Bioreactor Case Study: Challenges Encountered from a Small Scale Process Development Perspective – Job Garcia, Amgen

• 9:40a.m. Hydrodynamics and Mass Transfer in an Advanced-Flow Reactor – María José Nieves Remacha1, Klavs F. Jensen2, 1Eli Lilly and

Company, Alcobendas-Madrid, Spain, 2Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, United States


Day 2 - Morning

• 10:10a.m. Process Mass Spectrometers - Now a PAT/QbD Tool for Cell Culture – Peter Traynor, Graham L. Lewis and Daniel Merriman, Thermo

Fisher Scientific

• 10:30a.m. Break (POSTERS)

• 11:00a.m. Lessons Learned in the Implementation of New Technologies in Manufacturing: Variable Path-length UV Methodology as a PAT Case Study – Olga Simakova, Amgen Manufacturing LTD and Samuel Hernandez, Amgen,

Puerto Rico


Day 2 - Morning

• 11:30a.m. Perspective on the Application of Multivariate Technologies in Biopharmaceutical Manufacturing – Chris McCready, MKS Data Analytics Solutions (Formerly MKS

Umetrics)

• 11:50a.m. The Latest Development in Advanced Process Analyzers and Typical Applications – Yan Wang, Bruker

• 12:10p.m. Vendor Overview Presentations – All Vendors

• 12:30p.m. Lunch


Quadrant IVPharmaceutical Engineering & Control for PAT &

QbD - Management of PAT Data Session Chair: Darlene Santiago, Ph.D.,

UPR, San Juan, PR

Day Two - WednesdayAfternoon


Day 2 - Afternoon• 1:30p.m. Use of Blend Chemometric Models as a Control

Strategy for a Continuous Manufacturing Process – Jenny Vargas, Janssen, Gurabo, PR

• 2:00p.m. Quality-By-Control (QbC) Technologies for Process Intensification in Crystallization S+ystems – Acevedo, David and Zoltan K., School of Chemical Engineering, Purdue

University, West Lafayette, IN

• 2:30p.m. Residence Time Distribution: Design and Application – Elvin Almodovar, Janssen, Gurabo, PR

• 3:00p.m. Break (POSTERS)


Day 2 - Afternoon• 3:30p.m. Real Time PAT Based Measurement and Control

Powering the Move From Batch to Continuous Production– Martin Gadsby, Optimal Industrial Automation, Bristol, UK

• 3:50p.m. Assessment of Robustness for a Near Infrared Concentration Model for Real Time Release testing in a Continuous Manufacturing Process – Yleana Colon, Janssen, Gurabo, PR

• 4:10p.m. Full Spectrum of Control Strategies for a Continuous Direct Compression Line – Carlos Velezquez, C-PEDaL, Leonel Quiñones, UPRM and Miguel

Florian, UPRM


Day 2 - Afternoon

• 4:30p.m. Applying Advance Semiconductor Manufacturing Software Solutions to BioPharma – Amos Dor, Mike Thompson and Saly Romero-Torres, Applied Materials,

Sunnyvale, CA

• 4:50p.m. Industry Roundtable Discussion II - All Involved! – All Session Speakers

• 5:15p.m. Close/Reception


Posters

• A Novel Process Development Platform Incorporating Process Analytical Technology (PAT) for Influenza Vaccine Manufacturing – Lucas Vann and John D. Sheppard, North Carolina State University, Raleigh,

NC, USA

• Optimization of the Design of a Continuous Tumble Mixer – Miguel Florian-Algarin and Carlos Velázquez–Figueroa C-PEDaL, University

of Puerto Rico, Mayagüez, PR

• Continuous Manufacturing Plant for the Production of Pharmaceutical Tablets at C-PEDaL– Leonel E. Quiñones-Fontalvo and Carlos Velázquez–Figueroa, Center for

Pharmaceutical Engineering Development and Learning (C-PEDaL), Chemical Engineering Department, University of Puerto Rico, Mayaguez PR


Posters

• Study of NIR Chemometric Models on Films with a High Grade of Homogeneity. The Role of Sampling and Pretreatments Parameters on Errors – Carlos Ortega-Zuñiga,a Kerimar Reyes-Maldonado,b Rafael Méndez,b Kim H.

Esbensen,c and Rodolfo J. Romañacha* ,a Department of Chemistry, University of Puerto Rico at Mayagüez, Puerto Rico, b Engineering Research Center for Structured Organic Particulate Systems (CSOPS), Department of Chemical Engineering, University of Puerto Rico, Mayaguez Campus, Mayaguez, PR,c KHE Consulting, Copenhagen, Denmark


Exhibits (Table Tops)

Exhibitors• CAMO Software, Inc.• IBS Caribe, Inc.• Kaiser Optical Solutions, Inc.• MKS Data Analytics Solutions (Formerly MKS Umetrics)• Optimal Industrial Automation

Tuesday, June 21st

10:00 a.m. – 6:00 p.m.

Wednesday, June 22nd

10:00 a.m. – 4:00 p.m.


IFPAC Upcoming EventsADVANCE WITH IFPAC

IFPAC - Cortona, ItalyOctober 2-6, 2016

www.IFPACcortona.org

IFPAC-2017February 27 - March 2, 2017

North Bethesda, MD (Washington, D.C.) U.S.A.www.IFPACglobal.org

Email: [email protected]; Tel: 847-543-6800

http://www.ifpaccortona.org/

http://www.ifpacglobal.org/

mailto:[email protected]


IFPAC® QbD/PAT Summit with INDUNIV

The Essential Meeting in Puerto Rico for Quality by Design (QbD) and Process Analytical Technology (PAT)

We look forward to seeing you throughout the event!

www.IFPACsummit.orgIBS-CARIBE

INDUNIVUPR-M

UPR-SAN JUAN



http://www.ifpacsummit.org/

thirteenth annual ifpac qbd/pat summit with induniv · 2016-09-02 · ifpac/pat/qbd summit with...

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