Archived Content

Cambridge Healthtech Institute’s 4th Annual
Bioproduction: Scale, Bioreactors & Disposables
Making It Work
Part of CHI’s 6th Annual The Bioprocessing Summit

August 20-21, 2014 | Renaissance Waterfront Hotel | Boston, Massachusetts


Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios 

Thursday, August 21

8:00 am Registration and Morning Coffee


PROCESS DEVELOPMENT

8:25 Chairperson’s Remarks

Jessica Whelan, Ph.D., Director, Life Sciences, APC, Ltd.

8:30 Process Development Strategies to Enable Robust and Scalable Downstream Manufacturing Processes

Mi JinMi Jin, Ph.D., Group Leader, Biologics Process Development, Bristol-Myers Squibb

Monoclonal antibodies (mAbs) and Fc Fusion proteins constitute a major portion of the biopharmaceutical pipeline. Although the framework sequences and structural similarity among this class of molecules enable a platform approach to process development, product specific physicochemical properties can still pose significant challenges for process design, scale up and manufacturing process control. In this presentation, we will use several case studies to show some common challenges in chromatography, high concentration UF/DF and VF process design, and demonstrate the use of combined experimental and model based approaches to identify and mitigate potential issues early during development to deliver robust and scalable manufacturing processes.

9:00 Scale-Up Effects on Process Performance and Product Quality

Kishan Rao, MS, Senior Manager, Technical Services, Alexion Pharmaceuticals

Great care must be taken when committing to in-process limits or product quality specifications, particularly when there is limited full-scale process data to set those limits. Often, the clinical experience with a product quality range is what drives the product specification limits. If ranges are set prematurely or set overly narrow, inherent process variability or assay variability can cause the in process limits to be missed, the critical quality attribute to have a failure which ultimately could lead to lot rejection.

9:30 Fast and Easy Generic Anti-CHO HCP Analysis, 96-Samples Assay-To-Data in 65 Minutes

Dayne_DarickDarick Dayne, Ph.D., Senior Product Manager, ForteBio, A division of Pall Life Sciences

Pall ForteBio has teamed up with Cygnus Technologies to jointly develop an Anti-CHO HCP detection kit. While ForteBio Octet systems are the industry standard in easy and rapid high throughput analysis, Cygnus HCP ELISA kits are known for their broad HCP recognition and sensitivity. The new ForteBio-Cygnus Anti-CHO HCP kit will embody the best of both worlds. Users will achieve unparalleled time-to-results, streamlined and automated* workflow, enhanced dynamic range, and excellent precision and assay robustness.

* Complete hands-off automated workflow achieved with the Octet HTX system

10:00 Coffee Break in the Exhibit Hall with Poster Viewing


ENSURING QUALITY

10:45 Proton Transfer Reaction Mass Spectrometry - A Non-Invasive Approach for Advanced Bioprocess Monitoring

Gerald StriednerGerald Striedner, Ph.D., Assistant Professor, Biotechnology, University of Natural Resources and Life Sciences, Vienna

Limited real-time access to physiology relevant process variables is the major obstacle on the way to process understanding and rational process design. Proton transfer reaction mass spectrometry employed for real time measurement of volatile compounds in the offgas stream of bioreactors provides direct access to such meaningful information. Beside this the major advantage of this non-invasive real time monitoring system is that it can be implemented as additional monitoring tool even in already existing GMP production processes without interfering regulatory requirements.

11:15 Evaluation of Monochromatic UV for Viral Inactivation of Mammalian Cell Culture Media

LiYing YangLiYing Yang, Ph.D., Scientist II, Manufacturing Sciences & Technology, MedImmune, Inc.,  AstraZeneca Supply Biologics

Commercial scale facilities used in the manufacture of biologics using mammalian cell culture can be susceptible to undesirable adventitious agent contamination due to a number of factors including the complexity of the process, equipment, raw materials, and intrinsic property of the cell substrate. The biopharmaceutical industry has taken multipronged approaches to address the risk of viral contamination via testing of adventitious viruses, stringent raw material controls and sourcing, introduction of viral barrier technology in upstream operation, and performing viral clearance procedures in downstream processing activities. In this case study, novel monochromatic UV-B technology is evaluated for its viral inactivating capability of cell culture media, which can pose the highest viral contamination risks to a biologics manufacturing facility due to their complexity and varied composition/origin. Analytical testing and cell culture use studies were conducted to determine the effect of UV-B treatment on cell culture media and its feasibility for use in biologics manufacture. Preliminary viral inactivation results following UV-B treatment will be presented and discussed.    

 

11:45 Unique Mixing with Minimal Shear in Biobags

Henry BungayHenry Bungay, Ph.D., Emeritus Professor, H.P. Isermann Department of Chemical Engineering, Rensselaer Polytechnic Institute

In a machine that agitates up to sixteen transparent disposable biobags by alternate squeezing and release, unexpected eddies are observed when the front and back walls of the biobag are fastened together in favored locations. Restraining arms with lights and photodiodes send continuous turbidity data to a computer. Mixing determined by signals from the computer can be set visually for very low-shear for tissue culture or for turbulence for molds or bacteria.

Ansys12:15 pm Innovative Simulation Technologies for Bioreactor and Process Equipment Design 

Marc HornerMarc Horner, Ph.D., Lead Technical Services Engineer, ANSYS, Inc.

ANSYS experts will present simulation solutions for bioreactor and process equipment design. ANSYS simulation can offer insight into chemical reactions, mixing, and multiphase flows commonly found in bioreactors. Engineering simulation also predicts temperature, oxygen and species distribution as a function of the operating conditions in pilot or production reactor designs.

 

12:30 End of Conference 


Suggested Short Course*

Bioprocess Development: Considerations for the Quality and Safety of Materials in Contact with Biologics 

Thursday, August 21, 6:30-9:00 pm


*Separate registration required



Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios 


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