Dublin BioProcessing Technology Seminar - 21 May 2013
Please join us for this FREE event to learn more about the latest advancements in bioproduction technologies.
|
Time
|
|
Session |
|
|
|---|---|---|---|---|
|
8:30 a.m. - 10:00 a.m. |
|
Registration |
|
|
|
10:00 a.m. - 11:30 a.m. |
|
|
|
|
|
11:30 a.m. - 12:30 p.m. |
|
|
|
|
|
12:30 p.m. - 1:30 p.m. |
|
Lunch |
|
|
|
1:30 p.m. - 3:00 p.m. |
|
|
|
|
|
3:00 p.m. - 3:30 p.m. |
|
Break
|
|
|
|
3:30 p.m. - 4:30 p.m. |
|
|
|
|
|
4:30 p.m. |
|
Travel home |
|
|
Dublin BioProcessing Technology Seminar - 21 May 2013
Items marked with an * are required.
Citywest Hotel - Dublin
Situated on 380 acres of majestic parkland Citywest Hotel, Conference, Leisure and Golf Resort is a truly unique property and is located just 20 minutes from both Dublin City and Dublin International Airport. Combining the old world charm of a country house hotel, with state-of-the-art conference and event facilities, Citywest Hotel is truly a world class conference and leisure destination and one of the finest hotels in Dublin.
Guests can also enjoy complimentary parking, free Wi-Fi access, complimentary access to the newly refurbished Leisure Centre with its fully equipped gymnasium, 20m Pool, and treatment rooms. With such an array of facilities why not make this Four Star Dublin hotel your choice on your next visit to the capital!
Phone: +353 1 4010500
Agenda Abstracts
Choosing the appropriate materials of construction for single-use products and managing changes to them
As the number of bioprocess operations suitable for single-use technologies and products continues to increase, so too has the scrutiny on the impact of these technologies on the biologics production processes and products. This increased attention spans the biological, chemical, physical and mechanical characteristics of the single-use components and is heightened as these products are employed ever closer to the patient - up to and including final product vial filling operations that are intrinsic to biologics production. End-users need this information to assess the risk of using single-use products in their bioproduction operations. The speaker will discuss several specific characteristics of the plastics used to construct single-use containers.
Quantitative analysis - analytical testing
In recent years technology advances such as customized media forumulation and the adoption of single-use technologies have improved bioprocess manufacturing efficiencies. In this dynamic environment, bio-manufacturers face increasing challenges associated with various development activities and look to partner with suppliers with the expertise to provide quantitative and analytical testing services that are relevant to their bioprocessing needs. Through these partnerships, clients can utilize supplier analytical capabilities as a resource to perform routine non-critical analytical testing or specialized optimization projects for media, buffers and feeds. This presentation will investigate how Thermo Scientific™ Analytical Technologies have enabled bio-manufacturers to meet goals in production and efficiency gains.
Raw materials consistency (sourcing control, risk mitigation)
Quality medicines need quality materials because raw material properties affect the drug product. Specialized understanding is required to treat classic raw material (RM) issues, establish current RM CoAs, and effectively monitor and control RMs. In biopharma distinct RM considerations exist for such process components as sera, buffers, culture media, hydrolysates, proteins, bio-organics, and single-use product materials. Other considerations in RM sourcing include: proprietary, multiple-tiered, sole-sourced, QS, MRP (mfg. site, supply chain, material testing, CoA), and quality parameters (variability, trace components, performance). Often distinct analytics and testing concerns exist for identity (e.g., mislabeling and counterfeits, purity from contaminants such as residual solvents and adulterants). We consider definitions and specifications of such biological RM as phosphatidylcholine: "How much palmitoyl-oleyl-sn-phosphatidylcholine is in a particular product?" and "Does the degree of saturation of the acyl chains matter?". We also consider such biopharma-specific concerns as unique exclusions, e.g., GMOs and certain geographies. It is clear from the above that a depth of experience and the use of modern risk-based approaches are required to navigate this topic.
Characterizing single-use bioprocess container films - 10 critical material characteristics
Biologics production is increasingly reliant on single-use flexible containers for such critical applications as sampling, harvest, storage and as a shipping container. Flexible container systems consist of plastic films, ports, tubing and fittings. Performance of a specific container system depends on the materials and quality of construction as well as the conditions and constraints imposed by the application. The integrity of stored contents depends primarily on the characteristics of the film – which is the most important component of any flexible container system. The speaker will discuss the essential characteristics of flexible single-use containers and how these parameters influence any interactions between the flexible container and its contents.
HyPerforma S.U.M. DS 300
Single-use mixers offer significant advantages by eliminating the need for cleaning and sterilizing, reducing the risk of cross-contamination, and reducing cycle times. The Thermo Scientific™ HyPerforma™ Single-Use Mixer DS 300 (S.U.M. DS 300) provides enhanced mobility, interoperability, and modularity previously unavailable from mixing solutions. It can dock into multiple mixing barrels in 50, 100, 200 and 300L sizes. Single-use bioprocessing container bags were designed for each drum size. It is designed to efficiently mix powder-to-liquid or liquid-to-liquid solutions at different volumes for a wide variety of bioprocess applications: hydration of powdered media and buffers; sterile mixing of buffer solutions; cell culture media with sera and reagents or other process fluids; and pooling sterile liquid fractions. The HyPerforma S.U.M. DS 300 system adds value to your process by mixing and storing in multiple drums economically while maintaining a smaller footprint. You can now achieve greater process flexibility by doing more with less.
Turnkey open architecture
The Thermo Scientific™ HyPerforma™ Single-Use Bioreactor is the market leading bioreactor in stirred tank design. We have hundreds of installed systems worldwide used to grow numerous cell lines in a variety of processes. The bioreactor consists of a stainless steel outer container and a single-use bag assembly. The system can be ordered either in an open architecture format or as a turnkey system. The open architecture design allows customers to: integrate with any control platform on the market; plug-and-play through standard disposable connectors; avoid the costs of investing in an additional control system; and have the ultimate flexibility to choose the control platform they want. Get your turnkey solution using the control platform of your choice for either cGMP or non-cGMP applications.