Biopharma Manufacturing Processes and Equipment

Biopharma Processes and Equipment

Biopharma Manufacturing using Single-Use Technologies

Lesson Code: BPU-1114 (Premium) This e-Lesson is aimed at biopharmaceutical personnel who require a foundational knowledge of single-use systems and how they are used in the manufacture of biopharmaceutical products.

 

Overview of Biopharmaceutical Manufacturing

Lesson Code: BPU-1105 (PREMIUM LESSON) This e-Lesson is aimed at biopharmaceutical manufacturing personnel who require an overview of the main processes and conditions involved in therapeutic protein manufacture including upstream processing, downstream processing as well as formulation and fill finish.

 

Bioreactors in Bioprocessing

Lesson Code: BPU-1104 (PREMIUM LESSON) Describes the function, design, set-up and control of bioreactors in the biopharmaceutical industry. It examines control parameters such as heat management, pH, oxygen, mass transfer, and agitation, and how the type of cells being produced impacts on bioreactor set up and control. It also introduces the meaning of sterility, and bioreactor cleaning using CIP.

 

Fermentation in Biopharmaceutical Manufacturing

Lesson Code: BPU-1106 (PREMIUM LESSON) Describes how microorganisms are used in fermentation processes as part of biopharmaceutical manufacturing. Areas covered include growth phases and characteristics and conditions, cell banks, media, bioreactors and modes of operation, and the importance of sterility.

 

Cell Culture in Biopharmaceutical Manufacturing

Lesson Code: BPU-1107 (PREMIUM LESSON) This e-Lesson is aimed at biopharmaceutical personnel who require a foundation knowledge of cell culture as part of upstream processing in biopharmaceutical manufacturing. It describes mammalian cell culture in the biopharmaceutical industry, how such cultures are controlled and important considerations in maintaining optimal cultures.

 

Clean In Place

Lesson Code: BPU-1101 (PREMIUM LESSON) 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.

 

Downstream Processing: Centrifugation

Lesson Code: BPU-1103 (PREMIUM LESSON) Describes what centrifugation is and the stages of biopharmaceutical downstream processing where it can be used. Primary cell separation using a Disk Stack Centrifuge, and final purification using Ultracentrifugation are explained both in terms of equipment and process.

 

Downstream Processing: Ultrafiltration and Diafiltration

Lesson Code: BPU-1102 (PREMIUM LESSON) 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.

 

Downstream Processing: Protein Purification - Chromatography

Lesson Code: BPU-1110 (PREMIUM LESSON) Describes the use of various chromatographic methods in downstream protein purification including size exclusion, ion exchange, hydrophobic interaction and affinity chromatographies. The basics of a chromatography set-up are covered along with critical factors affecting protein separation such as column packing, resolution, column capacity, pressure and the gel matrix.

 

Formulation in the Biopharmaceutical Industry

Lesson Code: BPU-1109 (PREMIUM LESSON) Provides an overview of the principles and practices of formulation and packaging processes in a modern biopharmaceutical manufacturing facility.

 

Freeze Drying (Lyophilization)

Lesson Code: BPU-1113 (PREMIUM LESSON) Describes freeze drying (lyophilization), 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.

 

Process Validation: Process Design

Lesson Code: BPU-1111 (PREMIUM LESSON) An overview of the process design stage of process validation, describing how a biopharmaceutical manufacturing process can be defined using a Quality by Design (QbD) approach that emphasizes accumulated scientific knowledge and quality risk management.

 

Process Validation: Process Qualification and Control

Lesson Code: BPU-1112 (PREMIUM LESSON) An overview of the qualification and continuing verification stages of process validation, intended to demonstrate that a biopharmaceutical process is capable of reproducible commercial manufacturing and to provide ongoing assurance that the process remains in a state of control.

 

ATMP Manufacturing - Cell and Gene Therapies

BPU-1115 (Premium Lesson). This e-Lesson is designed for personnel who require an overview of the nature and function of cell and gene therapy products, their modes of manufacture (with a particular focus on autologous and allogeneic therapies), and the associated technical challenges and regulatory requirements.

 

Biopharma Manufacturing - Fundamentals

Biotechnology and Biopharmaceuticals -

Lesson Code: BPU-1100 (PREMIUM LESSON) Introduces biopharmaceuticals and their product characteristics. An easy to understand explanation of the science of biotechnology that underlies biopharmaceuticals is provided. This includes the role of DNA and proteins in the body, along with an explanation of Recombinant DNA Technology and Monoclonal Antibody Technology. The characteristics of biopharmaceutical products are explored and compared to traditional small molecule pharmaceuticals, and the main types of products described.

 

Cell Biology and Recombinant DNA Technology

Lesson Code: BPU-1108 (PREMIUM LESSON) Following on from BPU-1100, this Lesson goes a level deeper in its explanation of cell biology and how cells can be manipulated to produce therapeutic proteins. An overview is provided of the functioning of mammalian cells, followed by an explanation of the roles played by DNA and RNA in producing proteins in cells. The steps involved in recombinant DNA technology are outlined, including DNA amplification, insertion of target genes into suitable vectors, before cell culturing is explained.