BTEC Shorts

Overview of Processes for Manufacturing Biopharmaceuticals

The lesson will provide an overview of biopharmaceutical manufacturing within the framework of four stages, namely, Production, Harvest, Purification, and Formulation and Fill.

Introduction to Biopharmaceutical Products

This lesson introduces biopharmaceutical products, focusing on what they are, examples, and their impact on society. This lesson is one of several intended to provide context to the other, more specific topics being covered in the shorts program.

Introduction to Biopharmaceutical Dosage Forms

This lesson explores the most common final dosage forms used for biopharmaceuticals and provides an understanding of why these forms are preferred. This lesson also provides a foundation for understanding biopharmaceutical manufacturing processes by offering insights into the final products that these processes generate.

Expression Systems in Biomanufacturing

This lesson focuses on the different types of expression systems that are used in the production of biologics. 

Basics of E. coli Biology

This lesson describes key characteristics of E. coli and discusses its use in biomanufacturing.

Bacterial Growth Media

This lesson presents the basics of microbiological media with a focus on growing E. coli.

Semi-Solid Growth Media

This lesson discusses the advantages of semi-solid media for bacterial growth and describes aseptic plate pouring technique and proper storage.

Bacterial Isolation and Inoculation

This lesson explains how to streak for isolation using the T-streak method and how to start a pure culture.

Gene Cloning and Expression in the Bacterium E.coli

This lesson examines the fundamental principles and tools of molecular biology as applied to the bacterium E. coli.

Clean-in-Place (CIP)

This lesson examines the various types of CIP skids, important aspects of the CIP process, and engineering and configuration of CIP systems.

How to Work in a Biosafety Cabinet

This lesson provides an overview of biosafety cabinet usage, including how to clean, organize, and work aseptically within the workspace.

Growth Rate Determination

This lesson describes growth phases in batch format and explains how to calculate key growth parameters.

Cell Density Measurement

This lesson examines several methods and technologies to monitor cell density and viability.

Vial Thaw: Insect and Mammalian Cells

This lesson presents manual and automated thaw processes for cell cultures and discusses best practices for initial cell recovery. Two strategies are explored for recovering frozen stocks – vial format and bag format.

Seed Train and Upstream Scale-Up Considerations in Single-Use Systems

This lesson examines the logistics for seed train expansion, process considerations for scaling up using rocking bags and single-use bioreactors, and key advantages and disadvantages of single-use systems.

Introduction to Stainless Steel, Stirred Tank Bioreactors

This lesson focuses on the fundamentals of stainless steel, stirred tank bioreactor design.

Cell Lysis: What, Why, and How

This lesson introduces the topic of cell lysis in biopharmaceutical manufacturing, focusing on what it is, why it is needed and methods used.

Cell Lysis: High-pressure Homogenizers

This lesson focuses on high-pressure homogenizers, a common method for cell lysis in biopharmaceutical manufacturing. Topics covered are the design of a high-pressure homogenizer, principles underlying its operation, and the process parameters that impact homogenizer performance.

Solid-Liquid Separations in Downstream Processing an Overview

This lesson provides a brief overview of solid-liquid separations in biopharmaceutical processes as a preview to more in-depth lessons on the specific operations used.

Centrifugation Principles

This lesson discusses basic principles underlying centrifugation. Centrifugation is commonly used in biopharmaceutical manufacturing for solid-liquid separations. Centrifugation is particularly common in the harvest stage of a process but can be used in other stages as well.

Disc-stack Centrifugation, Part 1: Operating Principles

This lesson focuses on the operating principles for disc-stack centrifuges, among the most common types of centrifuges used in biopharmaceutical manufacturing.

Disc-stack Centrifugation, Part 2: Equipment and Procedures

This lesson focuses on equipment features and procedures for disc-stack centrifuges, which are commonly used for solid-liquid separations in biopharmaceutical manufacturing.

Chromatography Basics for Bioprocessing

This lesson covers the fundamental principles of chromatography, which is the primary method used for purification in bioprocessing. Chromatography is the main unit operation in the purification stage of the biopharmaceutical process. The primary goal is to remove soluble impurities from the product stream ensuring the product meets the required purity standards.

Ultrafiltration Basics for Bioprocessing

This lesson focuses on the basic operating principles of ultrafiltration, which is the primary method used for product concentration and buffer exchange in bioprocessing.

Ultrafiltration Process Configuration: Concentration and Buffer Exchange

This lesson focuses on the basic process configurations of ultrafiltration which is the most common unit operation during the formulation and fill stage of the biomanufacturing process. Formulation most often involves concentrating and buffer exchanging the product.

Mass Spectrometry — Fundamentals

This lesson introduces the basic principles of mass spectrometry (MS), such as ionization, mass analysis, and detection to understand its application in biopharmaceutical product identification.

MALDI Rapidly Confirming Product Identity

This lesson focuses on the principles and applications of MALDI-TOF mass spectrometry for biopharmaceutical analysis, emphasizing its role in rapid and accurate product identity confirmation.

Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis (SDS-PAGE)

This lesson includes an overview of traditional SDS-PAGE for protein analysis. SDS-PAGE is routinely used for protein quantitation and molecular weight determination at multiple stages of the biomanufacturing process.

Capillary Gel Electrophoresis for Analysis of Proteins

This lesson provides an overview of the capillary gel electrophoresis (CGE) method as part of analysis of protein products at different stages of the biomanufacturing process.

Purification of mRNA using Affinity Chromatography

This lesson provides an overview of the application of Affinity Chromatography to purify mRNA after synthesis. Affinity Chromatography is commonly used in industry to remove impurities from proteins, enzymes, nucleic acids, and other drug products.

Overview of HPLC Techniques for mRNA Quantification

This lesson provides an overview of HPLC for the separation and quantification of in vitro synthesized mRNA. HPLC is performed by analytical scientists in industry to evaluate process outcomes and separate homogeneous mixtures.

Applied HPLC for mRNA Quantification

This lesson explores the use of HPLC for the quantification of synthesized mRNA. HPLC is commonly used in industry to separate and quantify different components in mixtures.