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E-Learning Course: Essential Biopharma for Biopharma Manufacturing Employees (Certified) Product Image

E-Learning Course: Essential Biopharma for Biopharma Manufacturing Employees (Certified)

  • ID: 2374275
  • March 2014
  • Skillpad

This course consists of a series of 13 lessons:

(1) Introduction to Freeze Drying (BPU-710)
(2) Introduction to Sterilization and Prevacuum Autoclaving (BPU-760)
(3) Biopharmaceuticals - An Overview (BPU-800)
(4) Clean In Place (BPU-801)
(5) Downstream Processing: Ultrafiltration and Diafiltration (BPU-802)
(6) Downstream Processing: Centrifugation (BPU-803)
(7) Bioreactors In Bioprocessing (BPU-804)
(8) Overview of Biopharmaceutical Manufacturing (BPU-805)
(9) Fermentation in Biopharmaceutical Manufacturing (BPU-806)
(10) Cell Culture in Biopharmaceutical Manufacturing (BPU-807)
(11) Cell Biology and Recombinant DNA Technology (BPU-808)
(12) Formulation & Packaging in the Biopharmaceutical Industry (BPU-809)
(13) Protein Purification in Downstream Processing (BPU-810)

Lessons can also be purchased individually. Please see the “Also available” links below for further information on each of the individual lessons.

(1) Introduction to Freeze Drying (BPU-710)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. The Module is an introduction to freeze drying, its use in biopharmaceutical manufacturing, the structure of a freeze dryer and the freeze drying process, including critical parameters, cycle phases, process monitoring and control.

Objectives:

- Describe the advantages and disadvantages of freeze drying
- Describe the basic structure of a freeze dryer
- Describe the brief history of freeze drying
- Explain how both vacuum and refrigeration are used in freeze drying
- Explain what is meant by freeze drying
- Explain why freeze drying is used in the manufacture of biopharmaceuticals
- List and describe the three phases of the freeze drying process
- List and explain the critical freeze drying process parameters that must be monitored and controlled

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(2) Introduction to Sterilization and Prevacuum Autoclaving (BPU-760)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. The Module is an introduction to steam sterilization, different autoclave types and the steam sterilization process including critical parameters, the sterilization cycle, process monitoring and safety precautions

Objectives:

- Describe how steam sterilization cycles are monitored
- Describe the conditions needed for steam sterilization
- Describe the main components of a prevacuum autoclave
- Describe the safety precautions associated with steam sterilization
- Describe the uses of steam sterilization
- Describe what is meant by steam sterilization
- Explain the basic operating principles of gravity displacement and prevacuum autoclaves
- Explain the different stages of a sterilization cycle
- Explain what is meant by "sterile" and sterilization

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(3) Biopharmaceuticals - An Overview (BPU-800)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. The Module is an introduction to biotechnology and biopharmaceuticals. The role of DNA and proteins in the body is explained along with the key techniques of Recombinant DNA Technology and Monoclonal Antibody Technology.

Objectives:

- Describe the advantages and disadvantages of biopharmaceuticals
- Describe the principle of monoclonal antibody technology
- Describe the principle of recombinant DNA technology
- Explain the difference between biopharmaceuticals and 'traditional' pharmaceuticals'
- Explain the term 'biopharmaceutical'
- Explain the terms 'biotechnology' and 'pharmaceutical biotechnology'
- List and explain the key characteristics of biopharmaceuticals
- List examples of biopharmaceutical products

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(4) Clean In Place (BPU-801)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. This module explains key concepts of Clean In Place (CIP) technology commonly used in the biotechnology and pharmaceutical industries. It describes CIP processes and procedures and provides examples of best practices that help ensure optimum performance.
Objectives

- Explain the importance of CIP.
- Describe why and when a CIP should be performed.
- List the typical components of a CIP system.
- Describe the stages of a CIP operation.
- Explain the main variables that affect the performance of a CIP operation.
- Demonstrate capability in troubleshooting CIP and explain where the CIP process can go wrong.
- List the critical actions that you should take to ensure a CIP operation runs as efficiently as possible.

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(5) Downstream Processing: Ultrafiltration and Diafiltration (BPU-802)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. This module describes the downstream manufacturing processes of ultrafiltration and diafiltration with an emphasis on post-harvest volume reduction and concentration for therapeutic protein products. The components of an UF/DF skid and control of the UF/DF process are also described.

Objectives:

- Describe what is meant by ultrafiltration and diafiltration (UF/DF).
- Describe the different uses for UF/DF.
- Describe how UF/DF is used in downstream processing.
- Name the main components of an UF/DF skid and describe their purpose.
- Name the key instruments of an UF/DF skid and describe their purpose.
- List and explain the different steps of an UF/DF operation.
- List and explain the critical process parameters involved in an UF/DF operation.
- Describe the in-process checks and quality tests that are carried out during an UF/DF operation.
- Describe the safety and requirements associated with UF/DF equipment.

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(6) Downstream Processing: Centrifugation (BPU-803)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. This module describes how centrifugation can be used in the downstream processing stage of biopharmaceutical manufacturing. The equipment and processes involved for both primary separation and more advanced separation tasks are described.

Objectives:

- Explain why purification is critical in biopharmaceutical manufacturing.
- Explain the principle of centrifugation.
- Describe the structure, operating principles and applications of a disk stack centrifuge.
- Describe the structure, operating principles and applications of an ultracentrifuge.
- Explain why cleaning and sanitization of centrifuges is so critical.

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(7) Bioreactors In Bioprocessing (BPU-804)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. This module describes the function, set-up and control of bioreactors in the biopharmaceutical industry. It also explores the design of bioreactors and their different modes of operation.

Objectives:

- Explain why purification is critical in biopharmaceutical manufacturing.
- Explain the principle of centrifugation.
- Describe the structure, operating principles and applications of a disk stack centrifuge.
- Describe the structure, operating principles and applications of an ultracentrifuge.
- Explain why cleaning and sanitization of centrifuges is so critical.

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(8) Overview of Biopharmaceutical Manufacturing (BPU-805)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. This module explains the principles of biopharmaceutical manufacturing by focusing on the processes typically involved in producing therapeutic proteins. It will allow you to become familiar with critical concepts such as GMP and regulation, upstream and downstream processing, and formulation/fill finish.

Objectives:

- Describe the main types of biopharmaceutical products.
- Provide an overview description of a typical biopharmaceutical manufacturing facility.
- Explain why following GMP is critical in biopharmaceutical manufacturing.
- Explain ‘aseptic processing' and how it is achieved in biopharmaceutical manufacturing.
- Explain the term ‘Upstream Processing'.
- Explain the term ‘Downstream Processing'.
- Describe the purpose of formulation.
- Explain the terms CIP and SIP and their importance in the manufacturing process.

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(9) Fermentation in Biopharmaceutical Manufacturing (BPU-806)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. This module describes how microorganisms are used in fermentation processes as part of biopharmaceutical manufacturing. Areas covered include growth characteristics and conditions, cell banks, media, bioreactors and modes of operation, and the importance of sterility.

Objectives:

- Define fermentation with reference to microbial cell culture.
- Explain the phases of microbial growth and identify a microbial growth curve.
- Explain the critical differences between Batch, Continuous and Fed-Batch cultures.
- Describe the functions of a bioreactor and nutrient media.
- List the conditions that a bioreactor must satisfy for successful fermentation.
- Describe methods of sterilization of bioreactors.

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(10) Cell Culture in Biopharmaceutical Manufacturing (BPU-807)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. This module describes mammalian cell culture in the biopharmaceutical industry, how such cultures are controlled and important considerations in maintainuing optimal cultures.

Objectives:

- List the key characteristics of animal cells in culture
- Distinguish between primary cells and transformed cells and between adherent and suspension cultures.
- List the critical components of cell culture media.
- Describe the required characteristics of bioreactors used for culturing mammalian cells.
- Explain the importance of sterility and describe methods of sterilization of bioreactors.
- Explain cell banks.
- Describe the process of cell counting using a hemocytometer.

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(11) Cell Biology and Recombinant DNA Technology (BPU-808)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. This module provides an overview of the functioning of mammalian cells, the roles DNA and RNA play in the cell in producing proteins, and how these can be manipulated to produce therapeutic proteins and other useful biologics.

Objectives:

- Identify organelles in the cell and describe their function.
- Describe the structure of DNA (double helix and nucleotides).
- Explain the terms codon, amino acid, transcription and translation.
- Define post-translational modification and protein folding.
- Describe the effect a DNA mutation in a gene may have on the resultant protein.
- Explain the processes of molecular cloning and transfection.

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(12) Formulation & Packaging in the Biopharmaceutical Industry (BPU-809)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry. This module provides an overview of the principles and practices of formulation and packaging in a modern biopharmaceutical manufacturing facility.

Objectives:

- Describe the importance of product formulation with regard to biopharmaceuticals.
- Distinguish between the different roles played by APIs and excipients.
- Describe the function of different excipient types.
- Explain the key considerations for formulation: safety, stability, purity, effectiveness.
- Describe the main product forms used for biopharmaceuticals.
- Explain the various ways in which products may interact with packaging.
- Describe the factors involved in selecting packaging types.
- Describe the key techniques involved in sterile packaging.

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

(13) Protein Purification in Downstream Processing (BPU-810)

This Skillpad Biotech Module is ideal for both new and existing employees in the Biotech Industry.

Describes the use of various chromatographic methods in downstream protein purification. Pre-chromatographic techniques including solubilization and refolding, precipitation and sterile filtration are described. The differences between adsorption – desorption chromatography and flow through chromatography are presented before looking in detail at the main types of chromatography used in final protein purification - size exclusion, ion exchange, hydrophobic interaction and affinity chromatographies. The basics of a chromatography set-up are then covered along with critical factors affecting protein separation such as column packing, resolution, column capacity, pressure and the gel matrix.

This is a self paced highly visual interactive e-Learning Module, with a full audio voiceover, which can be taken online. It has a 16 question multiple choice Assessment which the Trainee can perform once they have completed the module. For the Certified option, a hard copy certificate is mailed to the Trainee, once they have achieved a score of 100% in their Assessment.

Product Description:

- Explain the role of different chromatographic methods in protein purification.
- Describe where chromatography fits into downstream processing.
- Construct a general outline of a protein purification process for both intracellular and extracellular proteins.
- Explain what is meant by preparative chromatography.
- Describe the difference between Size Exclusion, Ion-Exchange, Hydrophobic Interaction Chromatography and Affinity Chromatography.
- Explain terms such as solubility, charge, molecular size, adsorption properties and binding specificity.

Question What is the expected duration of this product?
Answer The Product: Essential Biopharma for Biopharma Manufacturing Employees, contains 13 e-Lessons and each will take on average 30 minutes to complete. Each Lesson has a 16-Question Assessment Quiz with it on which the "Certification" is based, and will take 5-10 minutes to complete per Lesson. So the total course of all 13 Lessons would take about 8.5 Hrs to complete. The Biotech Lessons are highly visual and interactive, and designed to allow the user gain confidence with the knowledge as they acquire it through scenarios and feedback questions, that don't form part of the formal assessment.
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