Abstracts Submitted

Regulatory Issues for the Biotechnological Product Manufacture

  1. Willis Thomas (USA). Compliance Awareness: Good Documentation Practices (GDPs) that reinforce Data Integrity (DI).
  2. Willis Thomas (USA). Analysis of Root Causes/Human Error Reduction.
  3. Lorely Milá (CIGB). Impact of regulatory changes in the biotechnological industry. A big challenge for novel therapeutic products.
  4. Boris Acevedo (CIGB). Change control: CIGB experiences through some selected study cases.
  5. Otto Reyes (ESINES). Start-up of the heating ventilation and air conditioning systems in an active pharmaceutical ingredient production plant.
  6. Mayté Pérez (CIGB). Comparability studies after the introduction of changes in active pharmaceutical ingredient manufacturing processes.
  7. Rebeca Bouyón (CIGB). Process validation strategy for the epidermal growth factor production based on a risk approach.
  8. Lourdes Costa (CIGB). The compliance with good manufacturing practices in analytical laboratories, an immediate challenge.
  9. Biorkys Yañez (CECMED). Legal framework in Cuba for manufacturing of biopharmaceutical products. Current affairs and challenges.
  10. Olivia Alegret (CECMED). Characterization of adverse drug reactions of biotechnology and generic products in elderlies.
  11. Anne Sulton (USA). Cannabis: Adverse Reactions with Prescription Medications. Case Studies.
  12. Anne Sulton (USA). Changing Global Landscape of Cannabis.
  13. Mirza Cerulia (CECMED). Manufacturing processes of sterile products. A regulatory view.
  14. Tania de la Cruz (CIGB). Design and implementation of a suitable equipment qualification program to pharmaceutical industry.
  15. Yanara García (CIGB). Converting a dedicated manufacturing unit into a multi-product manufacturing unit to produce for products in development phase.
  16. Danelis Velázquez (CIGB). Novel trends in quality management: real time release testing.
  17. Estrella Suarez CECMED). Transfer of technology. Regulatory points of view and impact on biopharmaceuticals.
  18. Isac Quiñones (CECMED). Validation of cleanliness in the pharmaceutical industry. Level of national implementation.
  19. Caridad Suarez (CIGB). Risk management application for implementing an alternative environmental monitoring program in a multi-product production unit.
  20. Marlen Herrea (CIGB). Evaluation of a chemically defined culture medium for obtaining the recombinant Streptokinase protein.
  21. Violeta Pérez (CECMED). Regulation for changes to approved biological products: New challenges.
  22. Zenia Pardo (CECMED). General Safety Test and the Rabbit Pyrogen Test in the quality control of biopharmaceuticals. Regulatory points of view.
  23. Yamila Leon (CIGB). Cold chain validation during the cold transportation of the buffy coats for transfer factor manufacturing process.
  24. David Goitozolo (CIGB). Raising the standard of the CIGB facilities.
  25. Vida Ortega (CIGB). Measurement of the effectiveness of cleaning and exposition time of materials employed in water sampling of critical systems.
  26. Yanieyis Alvarez (CIGB). Aseptic validation of the sterilizing filtration process: application of risk analysis in a multi-product facility a the CIGB.
  27. Wendy Rodríguez (CECMED). Good Practice requirements for cold chain in biopharmaceutical products.
  28. Antonio Cortes Pelegrin (Spain). Challenge of a Good Quality System in the Pharmaceutical Industry.
  29. Judy Umlas (USA). Grateful Leadership Drives Innovation.

Manufacturing and Development of Biotechnological Products

  1. Rodolfo Valdés (CIGB). Monoclonal antibody: comparison of in vivo and in vitro production methods and their use in vaccine active pharmaceutical ingredient manufacture.
  2. Hasel Aragón (CIGB). Continuous culture of CB.Hep-1 hybridoma cells using the Lambda MINIFOR bioreactor with a vertical stirring system simulating a fish-tail.
  3. Daily Hernández (CIGB). Generation and production of monoclonal antibodies for Vip3a monitoring in corn resistant to Spodoptera frugiperda.
  4. Leonardo Gómez (CIGB). Improvement of hepatitis B surface antigen purity in monolithic support immunoaffinity chromatography.
  5. Miguel Castillo (CIGB). New purification method designed for obtaining the hepatitis b surface antigen for human vaccination.
  6. Odalys Ruiz (CIGB). Statistical approaches to define medium composition for biomass production of recombinant Escherichia coli cells to obtain a therapeutic vaccine.
  7. Biunayki Reyes (CIGB). Microbiological impact in the new method of cleaning of vaccine production areas classified as grade A and B.
  8. Alberto Leyva (CIGB). Demonstration of the maintaining of the validated state of a system used to generate water for injection by thermocompression distillation.
  9. Eduardo Sánchez (CIGB). Viral validation of the nanofiltration step introduced in the transfer factor production.
  10. Andrés Tamayo (CIGB). Analysis of CB.Hep-1 immunosorbent industrial-scale manufacturing process consistency.
  11. Ivonne Rodríguez (CIGB). Evaluation of the step criticality in the hepatitis B virus surface antigen manufacturing process.
  12. Williams Ferro (CIGB). Purification of plantibodies from transgenic tobacco leaves combining aqueous two phase extraction system with affinity chromatography.
  13. Airela Llamo (CIGB). Impact of the activation and immobilization procedure modifications in the stability of the CB.Hep-1 immunosorbents based on BrCN-Zetarose CL4B.
  14. Yenisley Medina (CIGB). Assessment of affinity chromatography matrices with synthetic and natural ligands in purification of antibodies from seeds of transgenic tobacco plants.
  15. Denis Álvarez (CIGB). Refolding of granulocyte colony stimulating factor using a large-scale ultrafiltration/diafiltration step.
  16. Mónica Navarro (CIGB). Improvements in the granulocyte colony stimulating factor refolding step.
  17. Laura Varas (CIGB). Development of the fermentation process using a chemically defined medium to obtain the CIGB550-e7 protein in Escherichia coli.
  18. Mayté Quintana (CIGB). Impact of the ligand density on the elution capacity of immunosorbents used in the hepatitis B surface antigen purification.
  19. Jorge Rivera (CIGB). Improvements in the fermentation process for obtaining the hepatitis B virus core protein.
  20. Rachel Armona (CIGB). Improvements in purification process of the hepatitis B virus nucleocapsid antigen.
  21. Sigifredo Padilla (CIGB). Assessment of two transgenic tobacco plant varieties for the HBsAg specific plantibody production.
  22. Anabel Álvarez (CIGB). Co-development between CIGB (Cuba) and Davac (Vietnam) for obtaining PTg, Fha and Prn from the bpcnic0311 strain.
  23. Osnel García (CIGB). Adjustments in ion-exchange chromatography for the purification of the p64k.
  24. Rafael Fernández (CIGB). Characterization of the fermentation process induction phase designed to obtain the hepatitis B surface antigen.
  25. Rosali Ávila (CIGB). Development of a fermentation process designed to obtain the CIGB370 protein in Escherichia coli.
  26. Talía Tejera (MININT). Impact of the cell culture medium MyeloCIM use in the production of an antiCD20 monoclonal antibody.
  27. Dania Bacardi (CIGB). Preclinical development considerations to demonstrate bio-similarity between peg-GCSF and Neulasta®.
  28. Grechen Menéndez (CIGB). Application of risk analysis to two production technologies of CB.Hep-1 monoclonal antibody.
  29. Natacha Pérez (CIGB). Ion-exchange chromatography improvements in GCSF purification process.
  30. Vivian Pujol (CIGB). Heberprot-p manufacturing process consistency.
  31. Cristina Rodríguez (CIGB). Certification of the first Hebernasvac reference material.
  32. Liván Maseda (CIGB). Impact and consistency of the raw material weighing services unit for high added value active pharmaceutical ingredient production.
  33. Lisandra Licol (CIGB). Quimi-Hib® vaccine active pharmaceutical ingredient manufacturing process consistency.
  34. Tatiana Álvarez (CIGB). Quality risk management applied to a new CB.Hep-1 mAb purification process.
  35. José Montero (CIGB). Quality risk management applied to a chemical modification in the immunosorbent CB.Hep-1 purification process.
  36. Lianne Romero (CIGB). Validation of aseptic processing of sterilizing filtration of recombinant human epidermal growth factor used in the Heberprot p manufacture.
  37. Yoalin Vega (CIGB). Standardization of an ELISA-type immunoassay to quantify host strain proteins in the CIGB370 anti-tumor preparation.
  38. Yordanka Ojeda (CIGB). Validation of automatic washing machine of materials used in active pharmaceutical ingredient manufacture of Quimi-Hib® vaccine.
  39. Alien Valdés (CIGB). Validation of aseptic process of active pharmaceutical ingredient of Quimi-Hib® vaccine.
  40. Ana Aguilera (CIGB). Development of a new formulation for the treatment of hemorrhoidal disease using recombinant streptokinase as active pharmaceutical ingredient.
  41. Matilde López (CIGB). Hebernasvac. A therapeutic vaccine for the treatment of chronic hepatitis B, formulation development and characterization of the drug product.
  42. José Blass (CIGB). Selection and evaluation of a clone for recombinant alpha-amylase production.
  43. Nestor Espósito (CIGB). Pre-formulation and real-time stability study of the Cuban pentavalent vaccine.
  44. Belinda Díaz (CIGB). Glycoconjugated vaccines. Experience of the synthetic conjugate vaccine against Haemophilus influenzae type b Quimi-Hib®.
  45. Carlos Martínez (CIGB). Consistency of the Pichia pastoris fermentation process for HBsAg production for human vaccination.
  46. Javier Vázquez (CECMED). Cell-free systems: an affordable option to produce biopharmaceuticals.
  47. Julio Valdés (CIGB). Establishment of a new cell disruption method for transfer factor manufacturing.
  48. Gustavo Furrasola (CIGB). Production of alpha- and gamma-interferons to be combined in the HeberFERON product.
  49. Yanara García (CIGB). Converting a dedicated manufacturing unit into a multi-product manufacturing unit to produce for products in development phase.
  50. Alicia Llopiz (CIGB). Influence of insulin and glucose concentration on EPOhr production from CHO cells.
  51. Oscar Cruz (CIGB). Production of recombinant proteins in CIGB. 30 years of experiences.
  52. Laura González (CIGB). Implemenation of Acuabio production and documentation system flow.
  53. Yuniskey García (CIGB). Poliribosilribitol phosphate manufacture process consistency.
  54. Yeny de la Torre (CIGB). Risk management applied to the product quality review in HBsAg manufacturing process used as API in the vaccines production.
  55. Daniel González (CIGB). Assessment of new expanded bed adsorption chromatographies in the purification of epidermical growth factor for human use.
  56. Luis Pérez (CIGB). Performance qualification of fermentors used in the production of HBsAg.
  57. Yilian Bermudes (CIGB). Obtaining a novel formulation of CIGB-540 for topical use in the prevention of keloids and hypertrophic scars.
  58. Luis Selega (CIGB). Establishment and validation of a bioassay to evaluate the antiproliferative activity of PEG-Heberon®: Cuban pegylated Interferon.
  59. José García (CECMED). Validation of biopharmaceutical productions using recombinant Escherichia coli.
  60. Arturo Toledo (CIM). Process validation in the aftermath of USFDA 2011 guideline.
  61. Angela Fialgo (CIGB). Photostability study of Hebernasvac vaccine and its active pharmaceutical ingredient: the core antigen of the hepatitis B virus.
  62. Luciano Hernández (CIGB). Impact of the nebulization of hydrogen peroxide dry mist on cleanroom disinfection.
  63. Laura Gómez(CIGB-Camaguey). Increase in the fermentation process scale for Gavac biomass production.
  64. Francisco Castañera (CIGB). Recovery and productivity improvement of human transfer factor purification process.
  65. Wilmort Ferrero (CIGB). Novel methodology based on risk analysis for the selection of sampling points during the qualification of the fermenter sterilization.
  66. Ernesto Urritia (CIGB). Purification and production of alfa 2bIFN conjugated to 40 kDa polyethilenglycol.
  67. Hector Santana (CIGB). Epidermal growth factor quatsomes as a new nanomedicine for chronic wound treatment.
  68. Mayra Guzman-Kaslow (Puerto Rico). GK pharmaceutical contract manufacturing operations: gateway of the biosimilars to Puerto Rico.
  69. Ernesto Carlos Gonzalez (Puerto Rico). GK pharmaceuticals CMO strategies for the study of rare diseases and develop of biosimilar orphan drugs in Puerto Rico.
  70. Martin Hofmann (England). Renaissance of expanded bed adsorption chromatography with direct scale up from laboratory to 100 litre columns with unique revolutionary technology.