Upstream and Downstream Bioprocessing 〔海外情報〕

Choose one or two selections below:

Overview session 20-30 minute

Moving Beyond Chemically Defined Media

Learn how new approaches to cell culture media formulation are advancing the industry’s definition of defined media. Participants are engaged in a conversation around preferred methods for achieving consistent, optimal cell culture performance while increasing the safety profile of media by replacing animal-derived components with animal-free alternatives.

Basics of Cell Culture Clarification

This session will review depth filtration, fluid characteristics and their mutual interaction. This discussion includes depth filter construction, retention properties, and the basics of depth filter process development.

Depth Filtration Development - An Overall Approach

This session will include a detailed discussion on depth filter process development. Topics include experimental design and data analysis, depth filter variability, correct use of safety factors and economic considerations for depth filters coupled with sterile filters.

Advanced in Depth Filtration Technology -Millistak+ Pod

Enhanced productivity can be achieved by using the disposable and flexible Millistak+ Pod depth filtration product line. Greater yield, smaller footprint, increased operator safety are some of the major benefits brought by this innovative technology.

Improving Productivity in Downstream Processing

Improvements in feed stream titers translate into the need for improvements in downstream processing productivity. Second generation resins such as ProSep Ultra Plus offer Increased capacity, velocity, and enhanced stability to harsh cleaning and sanitization conditions.

ProSep Chromatography Media - Current Best Practices

Includes ProSep-vA HC, ProSep-vA Ultra, ProSep Ultra Plus, media and reviews the following aspects: media evaluation, purity and host cell protein clearance, cleaning and sanitizing, viral clearance, Protein A leakage and clearance, stability data, particle size, pressure / flow, column packing and handling.

Trace Impurity Removal with ChromaSorb Membrane Adsorber

Improved process economics can be achieved by using single-use, disposable Chromasorb anionic-charged membrane products for trace impurity removal such as host cell protein, nucleic acids, endotoxin, and virus.

TFF Basics

This session reviews basic TFF theory and application. Review of Millipore membrane technology and device options and construction. This discussion will also include membrane selection guidelines, and process success criteria.

Introduction to Pellicon 3 Cassettes

This session reviews Pellicon 3 cassettes features and benefits. Take a closer look at the inside of the device and the advantages it has to offer.

Fundamentals of Virus Filtration

This seminar describes the reasoning behind the regulatory guidelines for virus clearance, and the way in which virus filters work. It describes the Viresolve product line, features and benefits, and implementation of the Viresolve devices. It also describes Millipore’s support services for virus filtration.

Virus Filter Validation and RegulatoryGuidance

This seminar describes the challenges for virus filtration validation. It highlights Millipore’s expertise in this area, and also discusses alternative strategies to virus validation. It shows LRV results for Viresolve NFP and Viresolve Pro devices.

Advancements and Innovation in Virus Filtration Technology – Viresolve ProSolution

Describes the F&B of Viresolve Pro solution as they meet industry needs for parvovirus clearance.

Mobius Disposable Solutions and Capabilities

The presentation is an overview of the Mobius disposable platform including connectors, standard assemblies, mixing, and Mobius FlexReady platforms.

Disposable Mobius Mixing Solutions

This presentation will focus review the Mobius MIX100, 200, and 500 L mixing systems’ features, operation characteristics including mixing studies data, and process benefits with competitive positioning. Stainless steel versions and customization examples with load cells, and jackets will also be covered.

Mobius Standard Disposable Assemblies

Review of the standard offering from 50 mL to 2000 L volumes, in a variety of process applications and tour of the Digital Flip Book tool illustrating how these assemblies can be quickly and easily designed with the end-user based on a library of standard qualified components which will also be reviewed.

Fundamentals of Integrity Testing

Integrity testing is a critical operation in aseptic processing. Understanding test principles and practical application guidance lead to reliable testing. Basics physical properties of bubble point, diffusion are discussed. A detailed discussion of automatic integrity test instruments operation is included. Troubleshooting and re-test procedures complete the session.

Developing State of the Art Sterile Filtration Processes

Selecting the optimal sterile filter for any given application is a multi-step process that should include consideration of filter flow rate, capacity, sterilization processes, and ease of use. The latest advances in selection techniques are presented, including plugging mechanisms, scaling factors and and safety factors. In addition, we look at how to assure full scale implementation that will assure efficient operations. Flexible process development solutions that provide speed and ease-of-use are presented, including Millipore innovative Mobius FlexReady solution for buffer/media filtration.

Process Compliance and Recent Trends in Filter Integrity Testing

Regulatory scrutiny of integrity testing practices is increasing. Compliance with European regulations creates new considerations and challenges. In this seminar we explore regulatory guidance and practical application relative to post-sterilization/pre-use integrity testing, the role of integrity testing in sterility assurance, which filters should be tested and which should not, and how to improve test reliability. These topics will focus the discussion on test sensitivity, test value and troubleshooting practices in practical terms. We will also look at what is new in PDA Technical Report 26 revision regarding integrity testing.