Biomanufacturing 2019

Monday, September 30th to October 5th, 2019

Paradisus Princesa del Mar Resort & Spa

Varadero, Matanzas Province, Cuba

TWO PROGRAMS:


Manufacturing and Development of Biotechnological Products

Chaired By:

Keith L Carson, ChE, MBA BioProcessing Journal

and Oscar Cruz Gutiérrez, Eng, MSc CIGB

Regulatory Issues in the Manufacture of Biotechnological Products

Chaired By:

Willis H. Thomas, PhD, PMP, CPT Training Development Service (TDS)

and Luciano Hernández Marrero, MSc CIGB


MONDAY • SEPTEMBER 30, 2019

17:30 – 18:00

Welcome Speech and Program Presentation by Scientific Secretary: Rodolfo Valdés Véliz, BSc, PhD

18:00 – 18:45

Plenary Lecture by Invited Speaker: Luis S. Herrera Martínez, MD, PhD: Path from ideas to wide application range biotechnological products.

18:50 – 19:35

Plenary Lecture by: CEO of CIGB: Eulogio Pimentel Vázquez, BSc, MSc

TUESDAY • OCTOBER 1st, 2019

 

Manufacturing and Development of Biotechnological Products

<<Sala Polivalente Princesa>>

Regulatory Issues in the Manufacture of Biotechnological Products

<<Sala Garbos Bar>>

08:30 – 09:00

Keith Carson, ChE, MBA • BioProcessing Journal, ISBioTech

History of large-scale cell culture from T-Flasks to 5000 Liter, Single-Use Bioreactors

Willis Thomas, PhD, PMP, CPT • Training Development Service (TDS)

Compliance awareness: good documentation practices  that reinforce data integrity

09:05 – 09:35

Rodolfo Valdés Véliz, BSc, PhD CIGB

Monoclonal antibody: comparison of in vivo and in vitro production methods and their use in vaccine active pharmaceutical ingredient manufacture

 Fernando Tazón Álvarez, PhD • Asinfarma

Data integry

 

09:40 – 10:10

Duk Jae Oh,  PhD, Professor Sejong University

Enhanced production of recombinant human Interferon-beta through signal peptide modification in mammalian cells

Galina Moya Fajardo, BSc, MSC • CIGB

Current regulatory environment on data integrity in the pharmaceutical industry

 

10:15 – 10:45

Talia Tejera García, ChE • LCC

 Impact of the cell culture medium MyeloCIM use in the production of an anti-CD20 monoclonal antibody.

Lourdes Costa Anguiano, BSc, MSc • CIGB      

The Compliance with Good Manufacturing Practices in Analytical Laboratories, an Immediate Challenge

10:50 – 11:20

Ian Ransome, PhD• Sartorius

Systems: enabling high throughput biologics development for intensify process

Susanne Frasch, PhD • Neofroxx

Endotoxin Test Kits – Reliable test methods for safe products

 

11:20 – 11:40

Coffee Break  

11:45 - 12:15

Jan-Marc Lehky, PhD • Lambda-Instrument 

LAMBDA Laboratory Instruments

Mabel Izquierdo López, BSc, MSc • CIGB             

Biological assay for biotechnological product. current trends

12:20 - 12:50

Alicia Thalia Llopiz Sandó, ChE • CIM

Influence of insulin and glucose concentration on rhEPO production in CHO cells

Jose Luis Marcelo Sainz, BSc, MSc •  CIGB         

Determination of residuals solvents in the production of synthetic conjugate vaccine against Haemophilus influenzae type b

12:50-13:20

José Enrique Brito, ChE, MSc. CIGB

Development of a new formulation for the treatment of hemorrhoidal disease using recombinant streptokinase as active pharmaceutical ingredient

Ania Cabrales Rico, BSc, PhD  CIGB                    

Analytical characterization of protein aggregates obtained by chemical polymerization: standpoints for their use in quality control assessment

13:25-13:55

Hector Santana Milian, BSc, PhD CIGB

Epidermal growth factor quatsomes as a new nanomedicine for chronic wound treatment

Ivonne Rodríguez Lima, ChE, MSc •  CIGB           

Evaluation of the step criticality in the hepatitis B virus surface antigen manufacturing process

14:00-14:30

Nazende Günday Türeli, PhD MJR PharmJet        

Nanoparticle formulation and drug delivery systems

Devak Padmanabhan, PhD • Biozeen

Types of stainless steel and welding controls applied in the pharmaceutical industry for product-contact area

14:30-15:30

Lunch

 

<<Sala Polivalente Princesa>>

15:35-16:05

Marci Brown, BSc, PhD • ISBioTech  

Writing a well-structured and effective bioproduction paper for publication: Things I’ve learned from 14+ years of editing

16:10-16:40

Ernesto Galbán Rodríguez, BSc, MSc CIGB

A bibliometric approach of the field of bioprocessing and biomanufacturing

Biomanufacturing 2019: WEDNESDAY • OCTOBER 2nd, 2019

 

Manufacturing and Development of Biotechnological Products

<<Sala Polivalente Princesa>>

 

Regulatory Issues in the Manufacture of Biotechnological Products

<<Sala Garbos Bar>>

 

08:30 – 09:00

Oscar Cruz Gutierrez, ChE, MSc. CIGB               

Production of recombinant proteins in CIGB. Thirty 30 years of experiences

Fernando Tazón Álvarez, PhD • Asinfarma

Process Validation

09:05 – 09:35

Alistair Hurst , PhD •  Emp-BIOTECH

SMART Chromatography™ - Improving Downstream Purification Performance

Arturo Leopoldo Toledo Rivero, ChE, PhD • CIM              

Process validation in the aftermath of USFDA 2011 guideline

09:40 – 10:10

Belinda Díaz Montel, ChE. MSc • CIGB

 Glycoconjugated vaccines. Experience of the synthetic conjugate vaccine against Haemophilus influenzae type b Quimi-Hib®

Alberto Leyva Galvez, BSc, MSc  CIGB

Demonstration of the maintaining of the validated state of a system used to generate water for injection by thermocompression distillation

10:15 – 10:45

Devak Padmanabhan, PhD Biozeen

Equipment design & process control for efficient biologicals manufacturing

José García Suárez, ChE, PhD • CECMED

Validation of biopharmaceutical productions using recombinant Escherichia coli

10:50 – 11:20

Ernesto Urrutia Valdes, BSc, MSc • CIGB

Purification and production of alfa 2bIFN conjugated to 40 kDa polyethilenglycol

Rafael Beaus, PhD • Telstar                

Main changes in the revision of EU GMP Annex 1 of manufacturing of sterile products

11:20 – 11:40

Coffee Break

11:45-12:15

Carten Losh, PhD • Knauer

Simulated moving bed - a powerful tool for continuous purification of xylitol 

Luciano Francisco Hernandez Marrero, BSc, MSc • CIGB     

Impact of the nebulization of hydrogen peroxide dry mist on cleanroom disinfection

12:20-12:50

Derek Levinson, PhD • Emp-BIOTECH

empBIOTECH, products and separation technologies

Marcos Studer, PhD •  Amsonic/ HAMO

Automated High-Containment Cleaning Technology OEB 5 (OEL < 1µg/m3) with uncompromising operator protection for a validated cleaning result

12:50-13:20

Nadia Rodríguez Rodríguez, BSc.  CIGB

Obtaining a vaccine candidate against tumors expressing the E7 antigen of human papilloma virus type 18

Biunayki Reyes Días, BSc, MSc •  CIGB

Microbiological impact in the new method of cleaning of vaccine production areas classified as grade A and B

13:25-13:55

Susanne Frasch, PhD • Neofroxx

Culture media and peptones for biotechnological production

Rafael Beaus, PhD • Telstar                                        

Main containment systems and their characteristics: RABS vs isolators

14:00-14:30

Manuel Montané, MecE, MsC • CIGB

Transformation of CIGB pilot plat into industrial scale plant

Marcos Studer, PhD • Amsonic/ HAMO

Automated and validated cGMP cleaning technology

14:30-15:30

Lunch

 

<<Sala Polivalente Princesa>>

15:35-16:05

Mechtild Hofmann, PhD Seafront Biotech GmbH

SEAFRONT BIOTECH supplies

THURSDAY • OCTOBER 3rd, 2019

 

Manufacturing and Development of Biotechnological Products

<<Sala Polivalente Princesa>>

 

Regulatory Issues in the Manufacture of Biotechnological Products

<<Sala Garbos Bar>>

 

08:30 – 09:00

Keith Carson,  ChE, MBA • BioProcessing Journal, ISBioTech

Reference materials for viral gene vectors

Willis Thomas, PhD, PMP, CPT  Training Development Service (TDS)

Reducing and Preventing Human Error by Analyzing Root Causes

09:05 – 09:35

Elias Nelson Rodriguez Garcia, ChE, MSc.• CIGB

HeberNasvac, a therapeutic vaccine for the treatment of chronic Hepatitis B

Mayra Liz Guzman-Kaslow, PhD • GK Pharmaceuticals CMO        

GK Pharmaceutical contract manufacturing operations: gateway of the biosimilar to Puerto Rico

09:40 – 10:10

Imre Sallay, PhD.• DAISOGEL Group

The Bottleneck of Peptide-based API Production by Biotechnology: CIP

Estrella María Suárez Reyes, BSc • CECMED    

Transfer of technology regulatory point of views and impact in biopharmaceuticals

10:15 – 10:45

Carten Losh, PhD • Knauer

Technological aspects of modern (U) HPLC-systems

Eduardo Sánchez Zayas, BSc, MSc •  CIGB                                  

Generalities on Transfer Factor production process at the CIGB

10:50 – 11:20

Diamilé González Roche, BSc, MSc • CIGB

Improving the productivity of a system for the expression of recombinant Streptokinase through manipulation of the untranslated regions of the gene

Yanieyis Álvarez Delgado, BSc, MSc • CIGB                               

Aseptic validation of the sterilizing filtration process: application of risk analysis in a multi-product facility in CIGB

11:20 – 11:40

Coffee Break

11:45-12:15

Gustavo Furrazola Gómez, BSc, MSc • CIGB

Production of alpha- and gamma-interferons to be combined in the HeberFERON product

Anne Thomas Sulton, PhD, JD •  Marijuana Consultants International

Cannabis: Adverse reaction with prescription medications. Case studies

 

12:20-12:50

Bernd Baumstümmler, PhD • MJR PharmJet

Multimodal nanoparticle for structural and functional tracking of stem cell therapy on muscle regeneration nTRACK

Ernesto Carlos González Reyes, PhD GK Pharmaceuticals CMO

Strategies for the study of rare diseases and develop of biosimilar orphan drugs in Puerto Rico

 

 

 

Biomanufacturing 2019 (continued): THURSDAY • OCTOBER 3rd, 2019

 

Manufacturing and Development of Biotechnological Products

 <<Sala Polivalente Princesa>>

Regulatory Issues in the Manufacture of Biotechnological Products

<<Sala Garbos Bar>>

 

12:50-13:20

Leonardo Gómez Bayolo, BSc, MSc • CIGB

Improvement of Hepatitis B surface antigen purity in monolithic support immunoaffinity chromatography

Yusmel Sordo Puga, VM, MSc • CIGB                     

Potency and stability tests for the protein subunit porvac vaccine against classical swine fever administered by the intramuscular route in pigs

13:25-13:55

Odalys Ruiz  Hernández , ChE, PhD• CIGB

Statistical approaches to define medium composition for biomass production of recombinant Escherichia coli cells for obtaining a therapeutic vaccine.

Javier Eduardo Vázquez Romero  BSc, MSc • CECMED

Cell-free systems: an affordable option to produce biopharmaceuticals

14:00-14:30

Laura Varas Sarzo, ChE, MSc • CIGB

Development of a fermentation process using a chemically defined medium for obtaining the CIGB-550-e7 protein in Escherichia coli

Yair Quiñones Maya, ChE, MsC  CIGB

Impact of regulatory changes in the biotechnological industry. a big challenge for novel therapeutic products

14:30-15:30

Lunch

 

<<Sala Polivalente Princesa>>

16:10 - 16:40

Imre Sallay, PhD. • DAISOGEL Group

Exploring of further opportunities between Cuban companies and OSAKA SODA company

FRIDAY • OCTOBER 4st, 2019

 

Manufacturing and Development of Biotechnological Products

 <<Sala Polivalente Princesa>>

Regulatory Issues in the Manufacture of Biotechnological Products

<<Sala Garbos Bar>>

 

08:30 – 09:00

Martin Hofmann, BSc, MSc, PhD • Biotecflow

Renaissance of expanded bed adsorption chromatography with direct scale up from laboratory to 100 liter-columns with unique revolutionary technology

Biorkys Yáñez Chamizo, BSc, MSc • CECMED       

Legal framework in Cuba for manufacturing of biopharmaceutical products. current affairs and challenges

09:05 – 09:35

Imre Sallay, PhD.• DAISOGEL Group

The important properties for an Ideal stationary phase for HPLC.

Violeta Pérez Rodríguez, BSc, MSc • CECMED

Regulation for changes to approved biological products: new challenges

09:40 – 10:10

Carlos Martínez Laporte, ChE, MSc • CIGB

Characterization of the Pichia pastoris fermentation process for HBsAg production for human vaccination

Boris Ernesto Acevedo Castro, MD, PhD

Biotechnology Industry and Technologies: past, present and future of the Regulatory Context

10:15 – 10:45

Miguel Castillo Ferrer, ChE, PhD • CIGB

New purification method designed for obtaining the Hepatitis B surface antigen for human vaccination

Tania de la Cruz Curbelo, ChE, MSc • CIGB        

Design and implementation of a suitable equipment qualification program to pharmaceutical industry

 

10:50 – 11:20

Emre Türeli, PhD • MyBiotech GmbH  

Continuous cell disruption and extraction using microjet reactor technology

Arlene  Rodríguez Silva, BSc, MSc • CIGB           

Common technical document dossier for marketing authorization

11:20 – 11:40

Coffee Break  

11:20 – 11:40

Deivy Wilson, PhD • Brazil                 

Disposable biosensor based on an antimicrobial peptide for the detection of pathogenic bacteria in food samples

Zenia Pardo Ruiz, BSc, PhD • CECMED

The general safety test and the rabbit pyrogen test in the quality control of biopharmaceuticals. Regulatory points of view

11:45-12:15

Abel Hernández Velázquez, BSc, PhD • CIGB

Transgenic plants as platform for the production of pharmaceutical proteins: update from CIGB

Wilmot  Ferrero Bibilonia, ChE, MSc • CIGB                               

Novel methodology based on risk analysis for the selection of sampling points during fermenter sterilization qualification

12:20-12:50

María Pilar Rodríguez Molto, MD, PhD • CIGB

Development of veterinary vaccines, traditional methods and modern biotechnology approaches, looking for high efficacy and safety

Danelis Velázquez Cabrera, BSc • CIGB

Novel trends in quality management: real time release testing

12:50-13:20

Danny Pérez Pérez, VD, MSc • CIGB

PORVAC protects swine against viral challenge up to 6 months after a single dose.

Kenia Vázquez Montero, ChE, MSc • CIGB                                  

Combining risk management tools and product quality review with revalidation policy in CIGB

13:25-13:55

Catalina Álvarez Irarragorri, ChE, MSc • CIGB

Cuba biotechnology industry CIGB-MARIEL S.A to cover future production necessary in the recovery and productivity of the Transfer Factor purification process

Anne Thomas Sulton, PhD, JD, •  Marijuana Consultants International

Changing Global Landscape of Cannabis

14:00-14:30

Lunch

 

<<Sala Polivalente Princesa>>

15:35-16:05

 Miriela Gil Mena, ChE, MSc • CIGB                    

International Commercial Activity of the Center for Genetic Engineering and Biotechnology

20:00 – 20:30

Launching the 2nd Biomanufacturing 2021 by: Belinda Díaz Montel, Eng, MSc  <<Sala Polivalente Princesa>>

SATURDAY • OCTOBER 5st, 2019

11:00 – 12:00

Lunch at Hotel

12:00 – 15:30

Bus transport from hotel for delegates to Havana (CIGB)

 

Due to circumstances beyond the control of meeting organizers, this program is subject to change without notice.                                                                                                                                                                                                    September, 17th / 2019