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Introduction to TFF - Biomanufacturing

Introduction to TFFS engyong Lee Program ChairBiotechnology/ BiologyIvy Tech Community College Bloomington, IndianaMain Agenda Biomanufacturing and filtration filtration Principles Various Types of Filters Molecular Weight Cut Off Normal Flow Versus Tangential Flow Units of TFF TFF Operations in Clarification, filtration , Concentration, and Diafiltration Operation of TFF Hands -on Lab TFF Operation of Minimate TFF systems (Pall Corp.) CIP using N NaOH NWP and integrity test Separation and Concentration of Two Dye Molecules (Acid Yellow, kDa and Dextran Blue, 2000 kDa) Training Objectives Understand the overview of Biomanufacturing process.

Biomanufacturing & Filtration 4 Formulation and Filling Upstream Processing Cell Harvest and Product Separation Downstream Processing and Purification Liquid Prefilter Media Filtration Sterilizing -grade Liquid Filter Aeration Bioreactor Air Prefilter Sterilizing grade Air Filter Depth Filtration Tangential Flow Filtration Buffer Filter Capture ...

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Chapter 10 Upstream Processing - Biomanufacturing

biomanufacturing.org

use of airflow booths and following cleaning protocol explain the in-process controls for assessing media components illustrate the major types of bioreactors and associated instruments used for upstream biomanufacturing evaluate situations in order to make appropriate aseptic decisions

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Chapter 14 Sterile Filtration, Filling, and Lyophilization ...

biomanufacturing.org

containers (pharmaceutical container/closure). This operation exposes the sterile product to the environment, equipment, and manipulative technique of the operators until it can be sealed in the dose container; therefore, this operation is performed with a minimum exposure

  Pharmaceutical, Sterile, Closures, Filtration, Container, Sterile filtration, Pharmaceutical container

Chapter 10 Upstream Processing - Biomanufacturing

biomanufacturing.org

use of airflow booths and following cleaning protocol • explain the in-process controls for assessing media components • illustrate the major types of bioreactors and associated instruments used for upstream biomanufacturing • evaluate situations in order to make appropriate aseptic decisions

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Title: Column Chromatography of Green …

biomanufacturing.org

Title: Column Chromatography of Green Fluorescent Protein ... 4.1 Instructions from Biotechnology Explorer Green Fluorescent Protein ... (Bio-Rad catalog number 166 ...

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Overview Development and Manufacturing of …

biomanufacturing.org

2 Development and Manufacturing of Parenteral Drug Products Unit Overview Development and Manufacturing of Injectable (Parenteral) Drug Products From discovering the active ingredient to manufacturing the finished product, the production of

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Chapter 11 Downstream Processing - Biomanufacturing

biomanufacturing.org

Table 11-1: Commonly employed downstream processing methods (adapted from Kemp and O’Neil 2003) Processing Method Attributes Benefits Limitations Clarification: (often considered part of the upstream processing train) Sedimentation- based Clarification continuous centrifugation capable of handling very large harvest volumes open process-

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Chapter 13 Formulation Development of Parenteral Products

biomanufacturing.org

4 Chapter 13 – Formulation of Parenteral Products Introduction to Parenteral Products Basic theory Parenteral (para enteron—beside the intestine) administration is the introduction into the body of nutrition, medications, or other substances other than by the alimentary canal.

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Chapter 15 Inspection, Labeling, and Packaging

biomanufacturing.org

inspection without impacting overall batch quality. The American National Standards Institute/American Society for Quality Control (ANSI/ASQC) Z1.4-2008, Sampling Procedures and Tables for Inspection by Attributes is the primary reference used for setting AQL levels. Table 15-1. Sample AQL table based on ANSI/ASQC, Z1.4-2008 Batch Size Sample Size

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Chapter 11 Downstream Processing - Biomanufacturing

biomanufacturing.org

424 Chapter 11 - Downstream Processing Objectives This chapter provides an overview of downstream processing. After completing this chapter, students will be able to: Describe the general elements of the downstream purification process for a typical monoclonal antibody-based therapeutic, starting with the bioreactor harvest pool and

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Chapter 9 Quality Control Biochemistry

biomanufacturing.org

344 Chapter 9 - Quality Control: Biochemistry and reproducibility (inter-laboratory variability). Chapter 4 Metrology covers precision and the related term accuracy Purity assay: a quantitative analytical procedure used to determine the purity of the active product ingredient Purity method: a qualitative analytical procedure used to determine the purity of the active

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Water Soluble Polymers - SNF

snf.com.au

In liquid media and more particularly aqueous media,organic or inorganic materials are present in dissolved or solid form. These two forms are distinguished by the size of the particles. Dissolved compounds are: - Inorganic compounds, ions and/or organic com-pounds of low molecular weight with a particle size of at most 10-3 µm;

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Chapter 14 Sterile Filtration, Filling, and Lyophilization ...

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6 Chapter 14 – Sterile Filtration, Filling, and Lyophilization of Product Introduction Filtration through a membrane or bulk pad is used in pharmaceutical manufacturing to remove unwanted material from the formulated bulk solution. The primary purpose of filtration is …

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CUNO High Flow Filtration System The CUNO High Flow Filtration System is an advanced design that uses 3M Innovation and CUNO’s extensive filtration experience to deliver a high flow filter in a compact housing design. When compared to conventional cartridge systems, this system provides the following advantages: High Flow Capability

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