Showing posts with label Cell Based Assays. Show all posts
Showing posts with label Cell Based Assays. Show all posts

Thursday, August 7, 2014

Stay cool this summer with a 30% savings! Register by August 15 and save 30% off the standard rate!

Register now to get your cool savings off IIR’s 10th Annual Bioassays and Bioanalytical Method Development event with a 30% discount off the standard rate!*

Register here to join us and mention code XP1969Cool to take advantage of this discount.

The Bioassays event will take place October 20-22, 2014 in Boston, MA. Visit the website for full details. Don’t forget this event is co-located with IIR’s 15th Annual Immunogenicity for Biotherapeuticslearn more here.

Download the agenda here to see what’s on tap.

Have any questions? Email Mike Madarasz.

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Friday, September 14, 2012

Bioassays & Bioanalytical Method Development Session Spotlight: Development and Validation of a Cell-Based Viral Neutralization Assay

Cell-based assay approaches for NAbs are extremely complicated; no two are exactly the same. The necessary procedures are made even more demanding in the design of vaccines, because in that circumstance you want to provoke an immune response. It is worth the time required to master these taxing skills in order to demonstrate the most effective means of viral inhibition and minimization of rate of spread.

We'll be examinnig this topic at the Bioassays and Bioanalytical Method Development Event next month.  For more information on this session and the rest of the event, download the agenda.  As a reader of this blog, when you register to join us this October 1-3 in Berkley, California and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Development and Validation of a Cell-Based Viral Neutralization Assay
Featured Speaker: Peter Day, PhD, Associate Scientist, Genentech
About the session: You can best demonstrate effective means of viral inhibition through creation of two distinct MOA pathways, thus minimizing the risk and spread rate of infection. It is worth the time necessary to reorient your assay and analytic design processes around this goal, as the new inhibition results are crucial in the engineering of both vaccines and therapeutic proteins.
  • • Reinterpret immunoassay results in the context of seeking to provoke immune response
  • • Plan the best molecular design methods for viral load suppression
  • • Prepare for regulatory submission even when current guidelines are unclear


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Thursday, September 13, 2012

See Who's Attending IIR's Bioassay's and Bioanalytical Method Development Event

The 8th Annual Bioassays and Bioanalytical Method Development event is taking place in 3 weeks – October 1-3 in Berkley - and all the leaders in the bioanalytical R&D industry will be there including Vice Presidents, Heads, Directors and Sr. Scientists from:

* Abbott Biotherapeutics * Alexion Pharmaceuticals * Algorithme Pharma * Ambrx * Amgen * Amylin Pharmaceuticals * ATCC * AVEO Pharmaceuticals * Bavarian Nordic GmbH * BioAgilytix Labs * Biogen Idec * BioMonitor A/S * Catalent Pharma Solutions * Charles River Laboratories * Cirion Clinical Trial Services * Crucell * Eli Lilly * EMD Millipore * ENS - Cachan * Epizyme * Eureka Therapeutics * Fresenius Kabi USA * Genentech * Genzyme * GlaxoSmithKline * GSK Biologicals * Healthpoint * Human Genome Sciences * Immunogen * Incyte * Inovio Biomedical * Jennerex * MedImmune * Merck & Company * Merck KGaA * Merz Pharmaceuticals GmbH * OncoMed Pharmaceuticals * Pfizer * Planet Biotechnology * Promega * Regeneron Pharmaceuticals * RMC Pharmaceutical Solutions * Stem CentRx * University of California * Vaxinnate * Visterra *

The 8th annual Bioassays and Bioanalytical Method Development Conference will take place October 1-3, 2012 in Berkley, California. As a reader of this blog, when you register to join us today and mention code XP1768BLOG, you’ll save 15% off the standard rate! If you have any questions, feel free to contact Jennifer Pereira.


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Friday, August 17, 2012

Bioassays & Bioanalytical Method Development Session Spotlight: Development of a Novel Set of Release Assays for a Recombinant Influenza Vaccine

Most modern immunoanalysis was inspired by longstanding work in vaccine design - where, of course, an immunogenic result was the goal all along. How simple, effective, and accurate has it been to transition the methods meant to create immunogenic responses into now attempting to prevent them?

This year at the Bioassays and Bioanalytical Method Development Event, Vaxinnate will be on hand to take a closer look at this.  For more information on this session and the rest of the event, download the agenda.  As a reader of this blog, when you register to join us this October 1-3 in Berkley, California and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Development of a Novel Set of Release Assays for a Recombinant Influenza Vaccine
Speaker Scott Umlauf
Featured Speaker: Scott Umlauf, PhD, Director, Immunology and Analytical Testing, VAXINNATE
About the session: Creation of vaccines using recombinant protein technology can involve developing a novel set of release assays, at least some of which are biological in nature. VaxInnate’s technology utilizes a fusion of antigens with an innate immune stimulator.  Qualifying a cell-based assay for Toll-Like Receptor (TLR) activity has presented challenges, while replacing the Single Radial Immune Diffusion Assay (SRID) presents an opportunity to modernize influenza vaccine release assays.
  • • Cell-based TLR assays should accurately predict in vivo responses
  • • Curve discontinuity complicates mathematical analysis 
  • • Replacement of in vivo potency assays with ELISA or SPR desirable




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Thursday, August 2, 2012

Bioassays & Bioanalytical Method Development Session Spotlight: Use of Transfected Cells in Cell-Based ADCC Assays

Transfected cells are a type of cell that can make effector cells from serum far more predictable & reliable. Validated purified receptor surrogates are extremely useful in comparing to results from standard cell-based assays.

This year at the Bioassays and Bioanalytical Method Development Event, Pfizer will be on hand to take a closer look at this.  For more information on this session and the rest of the event, download the agenda.  As a reader of this blog, when you register to join us this October 1-3 in Berkley, California and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Use of Transfected Cells in Cell-Based ADCC Assays
Featured Speaker: Poonam Aggarwal, PhD, Senior Principal Scientist, PFIZER
About the session: The biggest challenge you are likely to face in designing robust ADCC assays is the inherent variability across different sources of human blood serum. Yet it is possible for your use of transfected cells to make the effector cells from serum more reliable and predictable. Analyzing the relative comparability of antibodies can shorten your workflow and cut down on some variable and confusing results.
  • • Evaluate ADAs to determine whether they are enhancing ADCCs or not
  • • Pinpoint the Fc gamma receptor binding signal using surface plasmon resonance
  • • Validate your purified receptor surrogates in order to best compare to results from standard cell-based assays



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Friday, July 13, 2012

Immunogenicity University debuts at IIR's Bioassays and Bioanalytical Method Development event

For the first time on the West Coast, the Immunogenicity University full-day summit at Bioassays and Bioanalytical Method Development 2012 will give you the training you need for the design, validation, and smooth transfer of robust immunoassays.

Experts at all career stages will benefit from these in-depth sessions that emphasize troubleshooting, improving result quality and turnover time, and matching the expectations of regulatory reviewers.

Walk away with in-depth knowledge from the leaders in research & development:
  • - Fundamentals of Immunogenicity Assessment 
    • - Presented by Edwin Golez, Scientist, AMYLIN PHARMACEUTICALS & Valerie Theobald, PhD, Scientific Associate Director, Clinical Assay Development, GENZYME
  • - Trusting your Data Chain: Assay Transferability 
    • -Presented by Shobha Purushothama, PhD, Principal Scientist, PKDM, BIOGEN IDEC and Shelley Belouski, PhD, Principal Scientist, Clinical Immunology Outsourcing, AMGEN
  • - Plan for Challenges in Preclinical and Clinical Development of Anti-Therapeutic Antibody Assays 
    • - Presented by Sally Fischer, PhD, Group Leader, Bioanalytical R&D, GENENTECH & Kate Peng, PhD, Scientist, GENENTECH
  • - Intensive Skill-Builder for Statistical Analysis 
    • - Presented by Martin Kane, PhD, Director of Process Statistics, HUMAN GENOME SCIENCES and Lanju Zhang, PhD, Senior Principal Statistician, MEDIMMUNE
For more information on the Immunogenicity University and the rest of the program, download the agenda.

The 8th annual Bioassays and Bioanalytical Method Development conference will take place October 1-3, 2012 in Berkley, California. As a reader of this blog, when you register to join us today and mention code XP1768LINK, you’ll save 15% off the standard rate! If you have any questions, feel free to contact Jennifer Pereira.


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Friday, July 6, 2012

Bioassays & Bioanalytical Method Development Session Spotlight: Anticipating and Assessing the Immunogenicity of Biologics—A Scientific and Regulatory Perspective

Cell-based assays are extremely challenging to use due to their innate uniqueness and the need to interpret them through complex statistical analysis programs. At the same time, FDA regulators often require the use of a NAb assay in order to test immunogenicity and demonstrate product safety – meaning this is a challenge that practitioners in this field cannot avoid. In this session Dr. Martin Lechmann, Associate Director of DMPK at Merck Serono, will provide specific case studies of methods to decrease the development time of these assays, while also increasing robustness, reproducibility, and potential for automation.

For more information on Bioassays and Bioanalytical Method Development, download the agenda.  If you'd like to join us in Berkeley, CA this October 1-3, 2012, as a reader of this blog when you register to join us and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Novel Approaches for the Detection of Neutralizing Antibodies
Featured Speaker: Martin Lechmann, PhD,Associate Director, DMPK, MERCK SERONO
About the Session: The development of reliable Nab assays is very challenging and takes a lot of time and resources until a validated NAb assay is up and running. Usually not only the development time is long but also the assay itself can last several days. Thus, cell-based Nab-assays are in general not suitable to analyze high number of samples. In addition, cell-based Nab assays are often susceptible to matrix background and special care has to be taken to assure that the neutralizing effects are attributed to antibodies. Particularly, robustness and reproducibility present major challenges. Therefore, new approaches are needed to decrease the development time and to increase the reproducibility of these assays. We will present different novel approaches with the aim to develop NAb assays that are more robust and have the potential for automation. These approaches include miniaturization of cell cultivation using Lab-on-Chip Technology and ready to assay cells.


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Wednesday, June 13, 2012

The 8th Annual Bioassays & Bioanalytical Method Development Agenda is ready for Download!

In the face of industry cost-cutting and consolidation pressures, every day that you get inconclusive results is a day when your job is on the line, and a day that the sick spend further away from a cure. Whether your greatest challenges focus on identifying critical reagents, successfully transferring assays among work sites and partners, or statistical analysis of complex cell-based assays, the 8th annual Bioassays & Bioanalytical Method Development conference is the one event you must attend to maximize the accuracy, stability, efficiency, and transferability of your workstream.


Assembled specifically to meet the needs of the bioanalytical R&D community, this conference will allow you to maximize ROI on your analytical methods through crucial knowledge-sharing on latest industry regulations, troubleshooting, and intricate but necessary methods for cross-referencing the results of multiple different assays.

This year’s agenda will build your bioanalytical skills through:
  • • Two unique co-located full-day summits: “Immunogenicity University” and “Cell Based Assay Academy,” which will get scientists at all career stages equally comfortable with basic foundational techniques and prepared for the more detailed state-of-the-art case studies to follow
  • • Critical guidance on how to sequence and interpret multiple bioanalytical methods in your workstream
  • • Answers to your most pressing development challenges on assays for vaccines and virology
  • • Over 15 never-before-heard case studies presented by an international faculty of leaders in the bioanalytical R&D industry!
The 8th annual Bioassays and Bioanalytical Method Development Conference will take place October 1-3, 2012 in Berkeley, California. As a member of this LinkedIn group, when you register to join us today and mention code XP1768BLOG, you’ll save 15% off the standard rate! If you have any questions, feel free to contact Jennifer Pereira.


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Tuesday, September 27, 2011

Who can you meet at Cell Based Assay and Bioanalytical Development next week?

This is your last chance to register for next week's 7th Annual Cell Based Assays and Bioanalytical Method Development event in Berkeley, CA.  Are you registered? Here are the companies can you meet while attending the event:

Abbott BioResearch Center * Ablynx NV * Acceleron Pharmaceuticals Inc * Alexion Pharmaceuticals Inc * Alta Analytical Intertek * Amgen Inc * Amyris * BioAgilytix Labs * Biogen Idec * Boehringer Ingelheim * Covance Laboratories * Crucell Holland B.V. * CSL Limited * Food & Drug Administration * Genentech Inc * Geron Corporation * Grifols Inc * GSK - Domantis Group * Hospira Inc * Human Genome Sciences * Institut Andre Lwoff * KaloBios * Laboratorios Raffo S.A. * LAJ Consultants * MedImmune * Merck & Company * MSD * National Biophotonics & Imaging Platform * Peregrine Pharmaceuticals Inc * Pfizer * PharmaNet Development Group * PPD * Regeneron Pharmaceuticals Inc * Stanford University * Takeda Pharmaceutical * Teva Biopharmaceuticals * UCSF Clinical & Translational Science Institute * University of Buffalo * Wake Forest Univ School of Medicine * ZymoGenetics Inc

For more information about this year's event, visit our webpage.


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Monday, September 19, 2011

Cell Based Assays & Bioanalytical Method Development helps Arm Your Assay Development with Critical Workshops

This October at Cell Based Assays and Bioanalytical Method Development, we are pleased to announce four intimate critical topic workshops that feature troubleshooting examples and group feedback on your most pressing issues. Don't miss out on this year's offerings:

2011 Critical Topic Workshops:
  • - Method Development for Liquid Chromatrography - Mass Spectrometry Applications in the Clinical Laboratory Setting
  • - Fundamentals of CBA — Tactics & Troubleshooting
  • - Using Design Of Experiment to your Greatest Advantage in Reducing Variance and Guaranteeing Translational Success
  • - Minimize Error Potential through Firm Establishment of Acceptance Criteria, Baselines, Cutpoints, and Outliers
This event will take take place October 3-5, 2011, in Berkeley, California. For more information on these workshops and their leaders, and the rest of the program, visit the Cell Based Assays & Bioanalytical Method Development webpage.


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Monday, August 22, 2011

Cell Based Assays and Bioanalytical Method Development Podcast: Chandra Dixit, National Biophotonics & Imaging Platform of Ireland

Chandra Dixit, Researcher, National Biophotonics & Imaging Platform of Ireland recently sat down with the Cell Based Assays and Bioanalytical Method Development team to discuss various methods of improving assay sensitivity and signal-to-noise ratios, in the context of his own work in developing high-sensitivity surface plasmon resonance immunoassays and nanoparticle-based imaging platforms.

Here's a excerpt from the podcast:

Could you describe your own work in bioanalytical method development?

Dixit: I am working on developing different platforms, like if you’re working assay development, you might have heard about developing immunoassays for phased plasmon resonance on focal imaging. So, what I’m trying to do is I’m trying to build a bioassay that is highly sensitive. When we are talking about enzyme immunoassays, then I’m trying to improve the sensitivity so that we can go far below the thresholds and that could be used to – that have huge applications in industry and diagnostics. And when I’m talking about SPL immunoassays and imaging platforms, then we certainly can go and make visualization of various particles. So, what I am doing is I’m developing a platform that could detect viruses or bacteria or cellular components down below that threshold that’s in our bodies. So, I will go one by one what exactly I am doing.

First of all, I was working with Bristol-Meyers Squibb. With them, what I did – they have bioprocess technologies going on. They develop different pharmaceutical products. So, they expected me to develop immunoassays that can detect impurities in their bioprocess systems. So, I developed five immunoassays, which are now translated and the technologies are transferred to them. So, in other cases I have developed few Surface Plasmon Resonance assays and currently I’m working on developing different high-sensitivity nanoparticle-based imaging systems, which uses silicone nanoparticle and which is, of course, high dose. These dyes are near infrared dye, which comes into the range of – the fluorescence comes into the range of near infrared region. So, this is all about my work.


To read the entire transcript and listen to the podcast, download it here.

Cell Based Assays and Bioanalytical Method Development event is taking place October 3-5 in Berkeley, CA. For more information on Dixit's presentation and the rest of the program, download the brochure. As a reader of the Future of Biopharma Blog, register for this event with the special Priority Code XP1668Blog, to receive 25% off the standard rate! If you have any questions about the event, please feel free to contact Jennifer Pereira at jpereira@iirusa.com.


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Wednesday, July 20, 2011

A Special Message from the Cell Based Assays & Bioanalytical Method Development Chairperson

A message from Shan Chung, PhD; Scientist, Bioanalytical Sciences, Genentech; Co-Chair, Cell Based Assays and BioAnalytical Method Development 2011:

Dear Colleague,

We all face similar challenges in designing and validating assays and bioprocesses. Whether trying to secure cell sources that reliably present conditions of interest, determining criteria to identify and eliminate outlier results, or designing assays sensitive enough to track ultra low-abundance proteins, each step involves performance trade-offs that must be carefully considered and accounted for. And ultimately we all seek to design methods with proven transferability and clinical utility.

That is why I would like to invite you to attend IIR’s 7th Annual Cell Based Assays and BioAnalytical Method Development conference, to be held October 3-5, 2011 at the Claremont Hotel Club & Spa in Berkeley, CA. This year’s event will feature nearly 40 speakers, and will continue to offer the small-format discussions and troubleshooting sessions you have come to expect. To learn more, download the latest conference brochure.

Some of the topics we will cover include:
• Strategies for control and assessment of Fc effector functions of therapeutic antibodies
• A rapid approach to developing reporter cell lines for bioassays
• Bioanalytical test elements that facilitate comparability studies for the development of biosimilars
• Virus neutralization assays using multiple image-based technology platforms

For more information, download the event brochure.

Thank you very much, and I look forward to welcoming you to this event in October.

Sincerely,
Shan Chung, PhD
Scientist, Bioanalytical Sciences, Genentech
Co-Chair, Cell Based Assays and BioAnalytical Method Development 2011

As a reader of the Future of Biopharma Blog, register for this event with the special Priority Code XP1668Blog, to receive 25% off the standard rate! If you have any questions about the event, please feel free to contact Jennifer Pereira at jpereira@iirusa.com. Register by emailing register@iirusa.com.


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Thursday, May 19, 2011

Call for Speakers / Abstracts: Cell Based Assays and Bioanalytical Method Development Conference

The 7th Annual Cell Based Assays and Bioanalytical Method Development Conference will be held October 3-5, 2011 at The Claremont Hotel Club & Spa in Berkeley, CA. You are invited to submit speaking and/or poster proposals for consideration. The deadline for speaking proposal submissions is June 17.

Designed by leaders in the bioassay and bioanalytical industry, this meeting is the only place to connect with fellow scientists who are discovering new approaches and solutions to the assay development challenges you face every day. It will feature key updates on the latest regulatory developments, analysis of new whitepapers, and case studies of novel techniques. Networking and sharing solutions with your scientific colleagues will help you understand best practice in assay design and validation, which in turn will streamline your preclinical and clinical pipelines and facilitate drug discovery and safety maintenance.

Please direct all inquiries and suggestions to the Conference Producer, Matt Greenbaum at mgreenbaum@iirusa.com or (646) 895-7310.

To discuss sponsorship and exhibitor opportunities, contact Business Development Manager David Borrok at dborrok@iirusa.com or (646) 895-7485.


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Wednesday, September 22, 2010

Who can you meet at Cell Based Assays & Bioanalytical Method Development 2010?

Over the past 5 years, the Cell Based Assays and Bioanalytical Method Development Conference has been the only place to learn from the scientists at the forefront of new approaches and solutions to the assay development obstacles you face everyday.

This year, hear the latest regulatory requirements, white paper authors and most recent case studies on new approaches to troubleshooting bioassay and bioanalytical challenges.

These companies will be there, will yours?

AAI Pharma Inc. * Alder BioPharmaceuticals * Allergan Inc. * Amgen Inc. * Biogen Idec * Bristol Myers Squibb * CBER FDA * Center for Molecular Medicine & Immunology * Cephalon Australia Pty Ltd * Charles River Laboratories * Facet Biotech * Food & Drug Administration * Genentech Inc. * Gregory Maschek * Human Genome Sciences Inc. * ImClone Systems * Immunogen Inc. * IRX Therapeutics * KaloBios * Laboratory of Cellular & Gene Therapy * Macrogenics Inc. * MedImmune Inc. * Pfizer * PPD Inc. * Process Confidence * Promega Corporation * Roche Diagnostics GmbH * SafeBridge Consultants Inc. * Sanofi Pasteur * Shire Human Genetic Therapies * TOLERX * Trion Pharma GmbH * University of Louisville James Graham Brown Cancer * US Pharmacopeia * Willem Oosterveen * Wyeth Pharmaceuticals



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Wednesday, September 8, 2010

Cell Based Assays: An Interveiw with Xu-Rong Jiang, MedImmune

Speaker and Cell Based Assays Track Chair Xu-Rong Jiang, PhD, MD, Associate Director, Analytical Biochemistry, MedImmune, recently commented on the case study he'll be presenting at this year's conference taking place October 4-6, 2010, in San Francisco, California.

Download the MP3 here. Download the transcript here.
Visit the Cell Based Assays & Bioanalyitical Method Development agenda here.

First of all, can you tell us a little bit about your background?
Xu-Rong: I started cell based assay development back to 1998 at Geron for the early drug discovery. I have further developed cell based potency assays at Amgen since 2002. I was leading a group of scientists responsible for the development, qualification, validation of potency assays used for clinical and commercial biologic development. During the past 3 years, I have increasing responsibilities leading a large bioassay group responsible for development of cell based assays for low release biological characterization of biologics at MedImmune, a Biologic Subdivision of AstraZeneca. It has been my great pleasure working with Anne Reel, your program director, to present and co-chair at the Cell Based Assay Development conferences during the past 4 years. It is a very enriching experience for me.

Can you give us a preview of the case study you’ll be presenting this year? Xu-Rong: I have observed an increased level of interests and attendants of the conference during the past few years. Attendance of this conference really covers a great deal from the biopharmaceutical industry, especially for scientists the industrial leaders such as Genentech, Amgen, Biogen Idec, as well as for scientists from new emerging companies who wish to learn more from the industrial leaders and discuss their concerns. The case study I will present at this conference focuses more on a platform technology approach that will facilitate the development of homogeneous, fast and robust bioassays more effectively and efficiently. Specifically, this case study concerning the utilization of engineered cells for the development of cell based assays that could assess both Fab and Fc functionalities in a development- and QC-friendly manner.

What are you looking forward to at this year’s event?
Xu-Rong:
I think this year there are a couple of aspects that really have advanced from the past few years. Firstly, this year’s Cell Based Assays will be combined with Bioanalytical Method Development. So they are going to cover a broader range of topics, from cell based assays for potency, Fc effector function assessment, Nabs assays for immunogenicity, and assays utilized for PK/PD purpose.
Secondly, while I am serving on the advisory panel for the meeting organizers that we realized it would be great to attract regulators to present at the conference. This year,
2 Cell Based Assays & Bioanalytical Method Development Podcast: Xu-Rong Jiang, PhD
the conference has indeed attracted broader attendance, especially speakers from the FDA.
Last but not least, this year will held a Fc effector function session and a strategy white paper for the assessment of effector functions of therapeutic antibodies will be presented by An Song, PhD, Senior Scientist, Associate Director, BioAnalytical R&D, GENENTECH. I worked closely with her to co-author the manuscript that was submitted one month ago. All these aspects I believe will make this combined conference very unique.



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Thursday, May 13, 2010

New White Paper: Helpful Hints for Better Aseptic Technique

Jill Mariano, MD of the Cell Based Assays LinkedIn group recently shared the white paper Helpful Hints for Better Aseptic Technique. You can see the white paper here.


In 2010, we are combining the Cell Based Assays and Bioanalytical Development Conferences to provide one comprehensive event that encompasses both areas, yet leaving time to dive deeply into the content of each one using separate track sessions. For more information on this event, please visit the webpage.


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Wednesday, July 22, 2009

Cell Based Assays 2009

In its fifth year, IIR’s Cell Based Assays is the principal event for industry leaders and colleagues to discuss how to overcome the challenges of cell based assay development and validation.

For 2009, we have added more networking time for you and your peers, including the return of moderated round table sessions that will allow you to address all your current questions surrounding: regulatory considerations, assay development and validation efficiencies, potency assays, neutralization antibodies assays, technological advancements, statistical analysis, and more.

Additionally, we have organized a Dine-Around which will provide the ultimate Berkeley experience. This dinner is a venue for conference participants to meet others with similar interests, for Berkeley is an epicenter of food culture that offers an eclectic range of restaurants.

Don’t forget - make sure you register by this Friday, July 24th, to save $400 off the standard rate!

We also invite you to join our LinkedIn group to start networking with other professionals in the Cell Based Assays field to discuss such things as biopharmaceutical labs have many obstacles to overcome in developing, validating, maintaining, and transferring complex cell based assays in a quality control environment.


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