Small Scale Automated Vial Filling

For small scale vial filling operations the FLT features an ideal platform. With the ability to automatically fill, stopper, and cap most common vials with minimal size parts and a user friendly control system the FLT has the features big machine features in a compact package. The mobile cart and standard utility requirements the FLT can be utilized by several different users in a lab situation. The FLT can be used with a peristaltic pump, or a rolling diaphragm dosing system, both of which are available as a single use option from the Bosch PreVAS dosing system family. Utilizing an automated system reduces filling error and product loss in comparison to manual filling operations, reduced operator fatigue and improved productivity without adding headcount.

Scale-Up of Single-Use Depth Filtration Systems

Process development engineers are responsible for developing scale-up strategies for efficient and cost-effective manufacture of biological and bioprocess-derived products at bench-scale, pilot scale and at manufacturing scale. A central unit operation in the production of these various therapeutic proteins is cell clarification using depth filtration. Recently, single-use depth filtration technologies have been developed, at scales ranging from the lab, to R&D, process development and on to manufacturing.

In this educational webcast, Laura Brown, Scientific Application Support Specialist II with 3M Purification, will provide guidelines for scaling-up of single-use depth filtration systems, and will review the commonly used single-use depth filtration products used for biopharmaceutical manufacturing.

Rapid Development of Chemically Defined Media and Feeds through Replacement of Basal Hydrolysates

Protein hydrolysates are widely used in mammalian cell culture to improve cell growth and recombinant protein production. However, use of the hydrolysates can lead to significant process variability, due to the limited control of their source and final composition during manufacturing. On the other hand, development of chemically defined media and feeds requires a tremendous amount of work, including comprehensive library screening and spent media analysis.

In this educational webcast, Dr. Hao Chen, Associate Principal Scientist, BioProcess Development at Merck, describes a rapid method for developing chemically defined media and feeds for Chinese hamster ovary (CHO) cell lines from existing proprietary media and feeds by the replacement of basal protein hydrolysates with novel supplements. In the case studies presented, Dr. Chen shows that after two rounds of optimization, the protein hydrolysate was successfully replaced. The resulting cell growth, protein productivity, and product quality were similar in the chemically defined and original media. The entire development process was completed within six weeks.

Applied Biosystems® GoPure™ Prepacked Chromatography Columns

Convenient, flexible, and efficient purification of biomolecules

GoPure™ Pre-packed Columns: A high performance, flexible purification platform

Single-use technologies have been widely utilized in upstream processes for many years. Interest in improving operational efficiency, speeding facility turn around and elimination of product carryover risk is now driving adoption of ready-to-connect filtration and purification modules in downstream processing.For chromatography, performance and flexibility that is equivalent to traditional self-pack columns is a prerequisite for use in multiproduct facilities. This webcast will describe GoPure™ Pre-packed Chromatography Columns and a custom packing process for third party resins. Case studies will be presented that demonstrate column packing process stability and scalability.

Intensified Manufacturing: Economic Models Comparing Steel, Single-Use and Concentrated Process Options

Refine Technology, LLC, in conjunction with Biopharm Services, developed two economic models to examine the cost of goods and capital requirements of cell culture production facilities configured based on different production scenarios, including variables such as:

• Amount of product required
• Vessel sizes
• Number and type of vessels (stainless steel vs. single use)
• Product titer
• Seed train
• Upstream and downstream requirements

In this educational webcast, John Bonham-Carter, Vice President of Sales and Business Development at Refine Technology, analyzes the effect of these variables in relation to operating mode, continuous culture (perfusion) versus traditional fed batch. Join John as he presents results and discussion for facilities producing 50 and 500Kg of protein per year.

Navigating the Biopharmaceutical Regulatory Pathway: Replacing Undefined Raw Materials with Chemically-defined Substitutes

With market demands increasing, biopharmaceutical producers are constantly looking for ways to enhance product quality while reducing costs and risk. One way to meet these changing demands is to replace animal-derived supplements with chemically-defined substitutes. In this educational webcast, Dr. Michael Titus, Director of Quality Management and Regulatory Compliance with BD Biosciences, outlines the regulatory pathway involved in making such a switch. Dr. Titus will discuss:

• A background on the uses of supplements in the cell culture production process;
• Change control & risk management;
• And the regulatory path of making the switch to chemically-defined supplements.

Join Dr. Titus as he demonstrates how chemically-defined supplements can boost performance, reduce risk and increase consistency in commercially marketed biopharmaceutical products.

Blank Slate Biomanufacturing: Designing the Ideal Operation from a Blank Sheet of Paper

If you could start with a blank sheet of paper, what would your biomanufacturing operation look like? Robust, adaptable, cost-effective and efficient probably come to mind, but how do you get there? In this educational webcast, Parrish Galliher, Founder and CTO of Xcellerex, takes an in-depth look at the strategies involved in designing the ideal biomanufacturing facility from a blank slate. You’ll learn how to optimize your operation to:

• Increase Speed
• Enhance Flexibility
• Decrease Risk
• Improve Economics

View this webcast to discover the steps for maximizing your biomanufacturing process.

Key Aspects of Managing Early Phase Development Programs for Long Term Success

From selection of a cell line to release of the first clinical batch, product and process developers make decisions that have timeline, financial, and regulatory consequences. As contract manufacturing becomes the norm rather than the exception in our industry, it is important that a Sponsor and CMO make the best use of each other’s expertise for maximum benefit to product and patients. In this presentation, Dr. George Koch, Chief Scientific Officer for Contract Manufacturing and Director of Project Management with Fujifilm Diosynth Biotechnologies, provides insight into:

• Selecting a CMO
• Process and Method Development
• The First Tox Lots
• The First Clinical Lots

View this on-demand educational webcast to learn more about manufacturing best practices for preclinical activities.

Fill, Finish and Testing of Phase I/II Drug Products

Florida Biologix, a full service CMO for Phase I/II biologics, has significant experience with a variety of aseptic liquid fill projects. This presentation walks you through key considerations and decisions you will need to make when outsourcing a fill. This webcast discusses the major considerations involved in the process, such as:

• Timeline
• Component, Volume & Testing
• Documentation
• Execution
• Shipping, Handling and Storage

The presentation provides information that anyone looking to outsource a clinical batch liquid fill needs to know to help ensure a successful outcome.

Global Material Harmonization for Increased Effectiveness and Reduced Risk

As geographic distances continue to metaphorically shrink, there is an increased focus on improving operational effectiveness. But, in order to increase effectiveness, it is important to understand and mitigate risk. In this on-demand webcast, Ben Locwin of Lonza Biologics demonstrates how material harmonization can help reduce risk and increase effectiveness by allowing:

• Use of one material specification
• Shared testing
• Shared raw material qualifications
• And more.

View this webcast to learn more about how synchronization of raw material testing can not only improve effectiveness, but reduce risk and lower costs as well.