January 13 - 17, 2014
Renaissance Hotel and Palm Springs Convention Center Palm Springs, California

A Community Dedicated to the
Evolving Field and Future of Biotherapeutics

Cambridge Healthtech Institute’s Inaugural
Single-Use Technologies and Continuous Processing 
in Biopharm Manufacturing

Toward Wide-Scale Implementation of Disposables

January 13-14, 2014


Single-use technologies have been widely adopted by large and small biopharmacueticals alike in their manufacturing processes, whether in greenfield facilities or retrofitted into existing plants or a hybrid mix. Despite this, issues such as extractables and leachables, scalability and downstream processing remain a challenge.

Cambridge Healthtech Institute’s Inaugural Single-Use Technologies and Continuous Processing in Biopharm Manufacturing conference brings to the forefront the advances, innovations, options and limitations of single-use technologies, and discusses new opportunities for single-use applications and processes.

Day 1 | Day 2 | Download Production Brochure 

SUNDAY, JANUARY 12


4:00-5:00 pm Short Course Registration

5:00-8:00 Dinner Short Courses (SC1-SC7) More Details >> 

4:00-8:00 Main Conference Registration

MONDAY, JANUARY 13

7:30 am Conference Registration and Morning Coffee

 

E&L, Particulates And Supply Chain Risk Assessment 

9:00 Chairperson's Opening Remarks

Jerold Martin, MSc, Chairman, BPSA BoD and Technology (E+L) Committee

 

Keynote Presentation

9:10 Wide-Scale Adoption of Single-Use Systems – What are the Challenges Ahead from the Regulators', Suppliers' and End-Users' Perspectives

Jerold MartinJerold Martin, MSc, Chairman, BPSA BoD and Technology (E+L) Committee

While benefits of economy, containment, and even pollution control have been well documented, challenges still exist across the process spectrum, such as assurance of supply and change control, avoiding cytotoxicity in media preparation, risk assessment of process equipment migrants in downstream processing, and quality concerns for single-use systems in final formulation and filling. This presentation will highlight these concerns of end users and suppliers and describe how they are working together to ensure drug product quality and safety.

9:50 BPOG's Extractable Protocol Standardization Journey – Review 2013 Progress and Planning for 2014

Ken WongKen Wong, Deputy Director, Mtech/AP&T, Sanofi Pasteur

This talk will focus on an overview of 2013 BPOG extractable subteam's journal on extractable protocol standardization effort. I will review all the extractable standardization efforts from other groups (BPSA, PDA, PQRI - PODP, USP, ASME BPE, ASTM E55-04, ISPE and ELSIE) and complexities of how they relate to BPOG effort. I will also provide update on the current status of the standard extractable protocol, as well as the 2014 objectives for the BPOG extractable subteam.

10:20 Coffee Break

Entegris10:45 Particle Contamination of Single-Use Systems

Johnson_MikeMike Johnson, Life Science Applications Engineer, Entegris

This presentation will discuss some of the sources of particle contamination in single-use systems, how to remove them from process media and how to prevent them from being introduced in the first place. Supporting analytical data will be shared documenting the size and quantity of visible and non-visible particles found in a typical single-use assembly along with the identification of some of these particles.

11:15 Single-Use Supply Chain Risk

Leslie Cianella, EMBA, CPIM, CQA, Senior Sourcing and Procurement Manager, MedImmune, Inc.

The first step in developing a Risk Management Plan, is to develop a cross functional strategy for single use technology which aligns with the overall business plan, including the requirements from quality, supply chain, manufacturing, finance, R&D, business planning, and engineering within the organization. This talk will explore various insights in developing and adjusting strategies to manage risks, so that innovation and total cost of ownership benefits can be the focus of the integration.


Analytics of Single-Use Systems  

11:45 PAT Solutions for In-Line and At-Line Analytics from Single-Use Bioreactors

Jens TraenkleJens Traenkle, Ph.D., Head, PAT Biotechnology, Bayer Technology Services

Current technologies and new developments for in-line analytics compatible with SUBs will be discussed. Furthermore, in-house single-use solutions from BTS will be presented, which allow automated, extractive sampling from bioprocesses. This technology facilitates the automation of a variety of laboratory analytics, such as metabolites or amino acid panels or even analytics of the biomolecule itself and enables closed-loop control on these parameters. Applications will be presented.

12:15 pm Sponsored Presentation (Opportunity Available)

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

 

Overcoming Scalability and Downstream Processing Challenges 

2:00 Chairperson's Remarks

Adam GoldsteinAdam Goldstein, Principal Engineer, Genentech, Inc.

 

2:05 How to Integrate Single-Use Bioreactors into Vaccine Process Development and Scaling Up?

Sandrine Dessoy, Senior Manager, New Product Development, GlaxoSmithKline

After several years of experience with single use bioreactors, the Cell & Viral Technology department has decided to use disposable bioreactor to enhance the development of the vaccine processes. Single use bioreactor are now fully integrated in the pool of equipment used to perform process development and scaling-up activities. This presentation will highlight the characterization and benchmarking done on these new equipment compared to conventional glass and stainless steel vessels to ensure their right integration in this hybrid equipment platform.

2:35 Scaleable and Continuous Cultivation of Anchorage Dependent Cells in Single-Use Bioreactors: Challenges and Solutions

Brian LeeBrian Lee, Ph.D., President, PBS Biotech

Micro-carrier based suspension culture processes have been used to scale up the anchorage dependent cells in bioreactors. However, the large scale operation, especially in a single use bioreactor, presents its own challenges. In this presentation, a novel single use bioreactor system that enables large scale and continuous cultivation of anchorage dependent cells will be discussed including homogeneous particle suspension, low shear stress mixing, pre-loaded sterile micro-carriers, and an in-situ retention filter device as an enabling technology for these challenges.

3:05 Challenges in Developing a Completely Disposable Downstream Process

Ronald BatesRonald Bates, Ph.D., Director, MS&T, Bristol-Myers Squibb

The use of disposable technologies continues to increase in the biopharmaceutical industry. Bioprocessing bags, tubing, filters, connectors, etc. are routinely being used at all except the very largest scale across the industry. However the use of completely disposable processes, especially in the downstream area, is much less common. There are several potential reasons for this, many of which and potential solutions will be discussed during this talk.

 

3:35 Selected Oral Poster Presentation

Qualification and Management of Single-Use Consumable Materials in Biopharmaceutical Industry

Zhaoli Zhou, Ph.D., Materials Specialist, Manufacturing Sciences and Technology, Bristol-Myers Squibb Co.

With advancements in technology and competition between potential suppliers, the complexity of single-use products is increasing. As the end-users, biopharmaceutical companies are responsible to select, qualify and evaluate these products in order to meet stringent regulatory requirements. Efforts also need to focus on managing selected products to ensure consistency in quality and performance. This presentation proposed measures and pathways for selecting qualified single-use consumable materials for specific biopharmaceutical applications, material management strategies including consumable specifications and vendor change management practices.

3:50 Refreshment Break

 

Continuous Processing for Downstream Optimization 

4:15 Challenges of Multi-Column Continuous Chromatography in Downstream Processing

Kathleen MihlbachlerDr.-Ing. Kathleen Mihlbachler, Independent Consultant

Chromatographic processes are important in the downstream processing of bio-molecules. Over past 10 years, a significant shift in downstream approach has taken place, especially after the tremendous increase in the upstream expression levels of monoclonal antibodies. MCC chromatography in sequential and counter-current mode have become an attractive tool to overcome the “bottleneck”. Although, the SMB technology has a proven record in the manufacturing of synthetic pharmaceuticals; barriers still remain to implement the technology into the bio-pharmaceutical industry.

4:45 Continuous Antibody Capture Using Countercurrent Tangential Chromatography

Andrew ZydneyAndrew Zydney, Ph.D., Professor and Department Head, Chemical Engineering, The Pennsylvania State University

Countercurrent Tangential Chromatography (CTC) is a new technology that can provide truly continuous product capture and purification using a column-free system that overcomes many limitations of traditional column chromatography. All operations in CTC are conducted on a moving slurry continuously pumped through a cascade of static mixers and hollow fiber membrane modules. Experimental results using a Protein A resin showed good antibody yield, enhanced host cell protein removal, and more than 8-fold greater productivity than a conventional packed column.

5:15 Simulation and Optimization of Continuous Downstream Process in Biopharmaceutical Manufacturing

SeongKyu YoonSeongKyu Yoon, Ph.D., Assistant Professor & Director, Department of Chemical Engineering, Massachusetts Bio Manufacturing Center, University of Massachusetts

Continuous Bioprocessing has been getting more and more attention in the biopharmaceutical industry. A few platforms have been demonstrated in the downstream area, however it is questionable if the configured systems are optimal from the perspective of process economics and facility utilization. This talk will present a study on simulation and optimization of downstream continuous manufacturing. Issues such as media, processing time and quality will be addressed. Pros and cons of the continuous bioprocessing will also be reviewed.

Protein Simple

5:45-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing



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      Premier Sponsors: 

EMD Millipore 

 Novozymes (white) 

PerkinElmer NEW 2009 

 Protein Simple  

  

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Training Seminars 

Mon-Tues, January 13-14 

Biologics Formulation and Delivery  

 


Buzz Sessions
BuzZ Sessions are facilitated, small-group discussions. Interactive participation leads to problem-solving solutions and future collaborations around focused topics.
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