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Biopharmaceutical Development & Production Week 2015
March 30–April 2, 2015
Hyatt Regency Huntington Beach Resort & Spa
Huntington Beach, CA, USA
Come see us at the annual BDP Week at booth #103. Together, Thermo Scientific™ single-use technologies and Life Technologies™ bioprocessing portfolios provide you with innovative solutions and exceptional customer service. From drug discovery through large-scale commercial production, these two great Thermo Fisher Scientific brands represent decades of expertise and support, offering you a broad range of products for single-use technologies, cell culture, purification, and analytics. See our complete offerings at lifetechnologies.com/bioproduction.
Reserve your space to attend one of our speaker presentations. Space is limited, so reserve now.
Register now
Track: Single-Use Application
“Single-Use Fermentation—Performance and Evaluation”
Tuesday, March 31, 9:15–9:45 a.m.
Nephi Jones, R&D Advanced Technology Manager, Thermo Fisher Scientific
Nephi Jones is the R&D Manager leading the Advanced Technology team for the Bioprocess Production Division at Thermo Fisher Scientific in Logan, Utah. He holds BS and MS degrees in Biological Engineering from Utah State University and has 15 years of experience, focused on feasibility research, process development, and scale-up of biotechnology. Jones launched his career at HyClone Laboratories, which was acquired by Thermo Fisher Scientific. In 2004 he was a founding member of the team that would design the first commercially available stirred-tank single-use bioreactor. During his career his principal responsibilities have included: cell culture media development, bioprocess application engineering, system design engineering, process development, research engineer, and project management. He holds approved and pending patents covering applications for single-use bioreactors, mixers, single-use bioprocess containers, sterile fluid transfer, mixing/mass transfer optimization, fluid filtration, mechanical drive/sealing systems, biosensors, and downstream purification.
Track: Upstream Processing & Harvest Step
“High Octane Fed Batch: Process Intensification Reimagined”
Tuesday, March 31, 2:15–2:45 p.m.
Becky Moore, PhD, Sr. Scientist, Bioproduction R&D, Thermo Fisher Scientific
Dr. Becky Moore received her PhD in Biomedical Engineering from Rutgers University, where she worked on differentiating embryonic stem cells into hepatic and neural lineages. Her postdoctoral research at Mount Sinai School of Medicine was focused on hematopoietic stem and progenitor cell fate specification. She then moved into industry as a research scientist at Celgene Cellular Therapeutics, working on a DARPA Blood Pharming project to generate universal donor red blood cells. Moore is now a Senior Scientist for Bioproduction R&D at Thermo Fisher Scientific. She has been there for 3 years in the new product introduction team and has successfully launched products such as FunctionMAX™ TiterEnhancer and the EfficientFeed™ Plus products.
Track: Downstream Processing
“Capture Chromatography: Alternatives for Downstream Process Development”
Wednesday, April 1, 12:05–12:35 p.m.
Shelly Parra, Sr. Field Application Scientist, Thermo Fisher Scientific
Shelly Parra has over 18 years of experience in biotherapeutic process development, scale-up, technology transfer, manufacturing, and validation. She is currently a Senior Applications Scientist at Thermo Fisher Scientific and works with customers with POROS® and CaptureSelect™ chromatography resins at all different scales, ranging from 10 µL to 1,000 L. Prior to Thermo Fisher Scientific, Parra was employed at Amgen, Transkaryotic Therapies, and BASF Bioresearch. She holds BS and MS degrees in Biotechnology from Worcester Polytechnic Institute in Massachusetts.
Poster Presentations
The Benefits of High-Performing Chromatography Resins Including POROS® XQ, a New Strong Anion Exchanger
Abstract:
POROS® resins offer unique performance attributes and drive benefits to downstream processing. POROS® XQ resin is the newest addition to our product portfolio. This high-capacity, salt-tolerant, high-resolution anion exchanger enables unique selectivity, better separation, higher product yields, and reduced cost of goods. These application data will demonstrate the benefits of POROS® XQ resin to capture and polish chromatography in downstream purification.
Author: Shelly Parra, Sr. Field Application Scientist, Thermo Fisher Scientific
Growth of Aggressive Microbial Cultures Using the Thermo Scientific HyPerforma™ 30 L and 300 L Single-Use Fermentors
Abstract:
Fermentation production facilities can utilize the Thermo Scientific™ single-use fermentor (S.U.F.) as a more technologically advanced alternative to traditional stainless steel cleaning-in-place/sterilization-in-place (CIP/SIP) fermentor vessels without modifying their existing procedures. As microbial expression systems are moved to production volumes, they can easily be scaled from a benchtop fermentor (or flask) to the 30 L or 300 L working volumes of the S.U.F. We demonstrate various cultivation methods that include high gas flow, seeding at 20% working volume, and direct comparison of the S.U.F. to traditional stainless steel fermentors. The HyPerforma™ S.U.F. is designed specifically to address the high-performance requirements of dense, rapidly growing microbial cultures while delivering the advantages of quick process setup, reduced contamination risk, and high production quality that are also the industry-proven benefits of the original Thermo Scientific™ HyPerforma™ Single-Use Bioreactor (S.U.B.).
Author: Nephi Jones, R&D Advanced Technology Manager, Thermo Fisher Scientific
- The complete HyPerforma™ S.U.F. system consists of a fermentor vessel and Thermo Scientific™ S.U.F. BioProcess Container (BPC), which is available in 30 L and 300 L sizes with a 5:1 turndown ratio
- The system offers enhanced functionality, ease of use, and efficiency over sterilization-in-process (SIP) systems
- The HyPerforma™ S.U.F. maintains traditional stirred-tank fermentation design principles, including specific height-to-diameter ratios (3:1), top-driven impeller locations that help deliver optimum cell viability, and performance and scalability from process development through production
Take your process further. Dynamis™ medium provides you with the power to achieve higher titers, start faster, and streamline scale-up for upstream process development and bioprocessing.
Give your process development the best start possible.
The power to achieve higher titers
- Up to 170% titer vs other available glucose-only fed media
- Up to 60% better fed-batch production when used with Gibco® EfficientFeed™ C+ Supplement vs alternative fed-batch systems
The power to start faster
- Higher sustained cell densities than alternative media when fed with glucose-only
The power to streamline scale-up
- Just add water Advanced Granulation Technology™ dry media format (AGT™) simplicity of reconstitution
- Animal origin free and chemically defined properties help streamline regulatory processes
Introducing POROS® XQ: the latest addition to the high-performance POROS® resin portfolio
- POROS® XQ resin is a next-generation high-capacity, high-resolution, salt-tolerant, strong anion exchange resin
- It enables >140 mg/mL of dynamic binding capacity in the presence of up to 6.5 mS/cm NaCl, while delivering exceptional separation performance
CaptureSelect™ bioprocess resins for large scale manufacturing
| Product | Target applications | Uniqueness |
|---|---|---|
| CaptureSelect™ IgG-CH1 | Human IgG antibodies and Fab fragments | CH1 domain binding, no free light chain binding for fragments |
| CaptureSelect™ KappaXL | Human IgG antibodies and Fab fragments containing a kappa light chain | Mild elution for fragments and antibodies |
| CaptureSelect™ FcXL | Human IgG antibodies and Fc-fusion proteins | CH3 domain binding, human specific, recognizing all four subclasses, mild elution conditions |
| CaptureSelect™ FSH | Human follicle stimulating hormone | Binds only intact FSH due to alpha/beta chain epitope |
| CaptureSelect™ HSA | Human serum albumin, albumin fusion proteins | Mild elution conditions |
MycoSEQ™ Mycoplasma Detection System
- Proven Power SYBR® Green technology for highly sensitive detection down to 1–3 genome copies per PCR reaction
- Intensive bioinformatics utilized in primer design to enable detection of more than 90 mycoplasma species
- Same-day results enable multiple in-process sampling points
Track: Single-Use Application
“Single-Use Fermentation—Performance and Evaluation”
Tuesday, March 31, 9:15–9:45 a.m.
Nephi Jones, R&D Advanced Technology Manager, Thermo Fisher Scientific
Nephi Jones is the R&D Manager leading the Advanced Technology team for the Bioprocess Production Division at Thermo Fisher Scientific in Logan, Utah. He holds BS and MS degrees in Biological Engineering from Utah State University and has 15 years of experience, focused on feasibility research, process development, and scale-up of biotechnology. Jones launched his career at HyClone Laboratories, which was acquired by Thermo Fisher Scientific. In 2004 he was a founding member of the team that would design the first commercially available stirred-tank single-use bioreactor. During his career his principal responsibilities have included: cell culture media development, bioprocess application engineering, system design engineering, process development, research engineer, and project management. He holds approved and pending patents covering applications for single-use bioreactors, mixers, single-use bioprocess containers, sterile fluid transfer, mixing/mass transfer optimization, fluid filtration, mechanical drive/sealing systems, biosensors, and downstream purification.
Track: Upstream Processing & Harvest Step
“High Octane Fed Batch: Process Intensification Reimagined”
Tuesday, March 31, 2:15–2:45 p.m.
Becky Moore, PhD, Sr. Scientist, Bioproduction R&D, Thermo Fisher Scientific
Dr. Becky Moore received her PhD in Biomedical Engineering from Rutgers University, where she worked on differentiating embryonic stem cells into hepatic and neural lineages. Her postdoctoral research at Mount Sinai School of Medicine was focused on hematopoietic stem and progenitor cell fate specification. She then moved into industry as a research scientist at Celgene Cellular Therapeutics, working on a DARPA Blood Pharming project to generate universal donor red blood cells. Moore is now a Senior Scientist for Bioproduction R&D at Thermo Fisher Scientific. She has been there for 3 years in the new product introduction team and has successfully launched products such as FunctionMAX™ TiterEnhancer and the EfficientFeed™ Plus products.
Track: Downstream Processing
“Capture Chromatography: Alternatives for Downstream Process Development”
Wednesday, April 1, 12:05–12:35 p.m.
Shelly Parra, Sr. Field Application Scientist, Thermo Fisher Scientific
Shelly Parra has over 18 years of experience in biotherapeutic process development, scale-up, technology transfer, manufacturing, and validation. She is currently a Senior Applications Scientist at Thermo Fisher Scientific and works with customers with POROS® and CaptureSelect™ chromatography resins at all different scales, ranging from 10 µL to 1,000 L. Prior to Thermo Fisher Scientific, Parra was employed at Amgen, Transkaryotic Therapies, and BASF Bioresearch. She holds BS and MS degrees in Biotechnology from Worcester Polytechnic Institute in Massachusetts.
Poster Presentations
The Benefits of High-Performing Chromatography Resins Including POROS® XQ, a New Strong Anion Exchanger
Abstract:
POROS® resins offer unique performance attributes and drive benefits to downstream processing. POROS® XQ resin is the newest addition to our product portfolio. This high-capacity, salt-tolerant, high-resolution anion exchanger enables unique selectivity, better separation, higher product yields, and reduced cost of goods. These application data will demonstrate the benefits of POROS® XQ resin to capture and polish chromatography in downstream purification.
Author: Shelly Parra, Sr. Field Application Scientist, Thermo Fisher Scientific
Growth of Aggressive Microbial Cultures Using the Thermo Scientific HyPerforma™ 30 L and 300 L Single-Use Fermentors
Abstract:
Fermentation production facilities can utilize the Thermo Scientific™ single-use fermentor (S.U.F.) as a more technologically advanced alternative to traditional stainless steel cleaning-in-place/sterilization-in-place (CIP/SIP) fermentor vessels without modifying their existing procedures. As microbial expression systems are moved to production volumes, they can easily be scaled from a benchtop fermentor (or flask) to the 30 L or 300 L working volumes of the S.U.F. We demonstrate various cultivation methods that include high gas flow, seeding at 20% working volume, and direct comparison of the S.U.F. to traditional stainless steel fermentors. The HyPerforma™ S.U.F. is designed specifically to address the high-performance requirements of dense, rapidly growing microbial cultures while delivering the advantages of quick process setup, reduced contamination risk, and high production quality that are also the industry-proven benefits of the original Thermo Scientific™ HyPerforma™ Single-Use Bioreactor (S.U.B.).
Author: Nephi Jones, R&D Advanced Technology Manager, Thermo Fisher Scientific
- The complete HyPerforma™ S.U.F. system consists of a fermentor vessel and Thermo Scientific™ S.U.F. BioProcess Container (BPC), which is available in 30 L and 300 L sizes with a 5:1 turndown ratio
- The system offers enhanced functionality, ease of use, and efficiency over sterilization-in-process (SIP) systems
- The HyPerforma™ S.U.F. maintains traditional stirred-tank fermentation design principles, including specific height-to-diameter ratios (3:1), top-driven impeller locations that help deliver optimum cell viability, and performance and scalability from process development through production
Take your process further. Dynamis™ medium provides you with the power to achieve higher titers, start faster, and streamline scale-up for upstream process development and bioprocessing.
Give your process development the best start possible.
The power to achieve higher titers
- Up to 170% titer vs other available glucose-only fed media
- Up to 60% better fed-batch production when used with Gibco® EfficientFeed™ C+ Supplement vs alternative fed-batch systems
The power to start faster
- Higher sustained cell densities than alternative media when fed with glucose-only
The power to streamline scale-up
- Just add water Advanced Granulation Technology™ dry media format (AGT™) simplicity of reconstitution
- Animal origin free and chemically defined properties help streamline regulatory processes
Introducing POROS® XQ: the latest addition to the high-performance POROS® resin portfolio
- POROS® XQ resin is a next-generation high-capacity, high-resolution, salt-tolerant, strong anion exchange resin
- It enables >140 mg/mL of dynamic binding capacity in the presence of up to 6.5 mS/cm NaCl, while delivering exceptional separation performance
CaptureSelect™ bioprocess resins for large scale manufacturing
| Product | Target applications | Uniqueness |
|---|---|---|
| CaptureSelect™ IgG-CH1 | Human IgG antibodies and Fab fragments | CH1 domain binding, no free light chain binding for fragments |
| CaptureSelect™ KappaXL | Human IgG antibodies and Fab fragments containing a kappa light chain | Mild elution for fragments and antibodies |
| CaptureSelect™ FcXL | Human IgG antibodies and Fc-fusion proteins | CH3 domain binding, human specific, recognizing all four subclasses, mild elution conditions |
| CaptureSelect™ FSH | Human follicle stimulating hormone | Binds only intact FSH due to alpha/beta chain epitope |
| CaptureSelect™ HSA | Human serum albumin, albumin fusion proteins | Mild elution conditions |
MycoSEQ™ Mycoplasma Detection System
- Proven Power SYBR® Green technology for highly sensitive detection down to 1–3 genome copies per PCR reaction
- Intensive bioinformatics utilized in primer design to enable detection of more than 90 mycoplasma species
- Same-day results enable multiple in-process sampling points
For Research Use Only. Not for use in diagnostic procedures.