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Earn a complimentary all-access pass to Immunogenicity for Biotherapeutics (IFB) conference by serving as a Guest Blogger at the event.

IBC’s 16^th Annual Immunogenicity for Biotherapeutics Conference

November 9-10, 2015

Hyatt Regency Reston

Reston, VA

We are looking for an industry expert with interest in the following topics:
• Immunology;
• Molecular biology;
• Bio-engineering;
• Microbiology;
• Molecular immunology, and more.

The premise is to provide Immunogenicity for Biotherapeutics - related articles, whitepapers, and overall original content.

What You get is:
• FREE pass to the conference (valued up to $2,399);
• Access to extensive social learning activities;
• Exclusive admission to a networking community in the industry of your interest!

You also have a chance to GAIN exposure through our five health related-blogs with over 2000 unique visitors monthly each and more than 20 healthcare LinkedIn groups.

Learn more about the IBC's Immunogenicity for Biotherapeutics event by visiting the website. 

Interested & want to learn more about this opportunity? Please contact Krista Lentini at klentini@iirusa.com or directly at 646-895-7316.

We hope to have you join us in Reston!

Cheers, The IBC's Immunogenicity for Biotherapeutics Team 2015
@ibcusa
#ibcImmuno
http://www.ibclifesciences.com/Immunogenicity/overview.xml
Future of Biopharma Blog http://futurebiopharma.blogspot.com/

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White Paper: T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation

At our upcoming Immunogenicity for Biotherapeutics Event, Anne S. De Groot will be joining us to present New Approaches & Emerging Technologies To Overcome The Effects Of Immunogenicity.

Ahead of that presentation, she shared a few of her recent research papers, including one titled T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation.   In this paper, they look at the strategies to assess immune responses to protein therapeutics during the preclinical and clinical phase of development.  In this particular white paper, they focus on Td contributions to immunogenicity.

Here is an excerpt:

1.1. The immunogenicity of protein therapeutics
Since the approval of the first recombinant biological therapeutic, insulin, in October 1982, more than 165 biotherapeutic agents have entered the marketplace and have generated an estimated $99 billion in sales worldwide [1], [2], [3] and [4]. Therapeutic biologics offer the advantages of increased specificity and reduced toxicity compared to small molecules. However, when administered to patients, these protein-based drugs have the potential to elicit immune responses that may directly impact drug safety, efficacy, and potency. For example, anti-drug antibodies (ADA) that develop in response to a therapeutic protein may alter the drug's pharmacokinetic profile and abrogate its pharmacodynamic effect (neutralizing activity) [5], [6], [7] and [8].

Immune responses to proteins are characterized by the generation of antibodies (humoral immune response) that could be T cell dependent or independent. T-independent antibody responses may be generated when B cells recognize a repeated pattern (motif) in the therapeutic protein and respond by transiently producing low-affinity, predominately IgM antibodies [9]. Antibodies that are generated in conjunction with T cell help are referred to as T cell-dependent or thymus-dependent (Td) antibodies. This process, described in the next section, involves a complex interplay among antigen presenting cells, T cells, secreted cytokines, and B cells, emphasizing the importance of genetic factors such as HLA haplotype expression and T cell/B cell repertoire in immune responses to administered proteins. Thus, measurement of ADA IgG responses usually indicates that T cells are involved in the immune response to the protein. Moreover, a number of clinical studies now suggest that high levels of T cell-driven IgG ADA have the potential to cross-react with the endogenous counterpart, an adverse effect that can have serious consequences [10], [11] and [12].

T cell responses contribute to the generation of ADA. Proteins with therapeutic potential are produced in cell lines that are derived from a variety of sources, including mammals (both human and non-human), insects, bacteria, plants, yeast, and viruses. Small differences in the protein sequence and/or post-translational modifications (e.g., glycosylation, oxidation, deamidation, acylation, and alkylation) can contribute to the immunogenic potential of the therapeutic protein. Furthermore, the manufacturing process may involve multiple steps (e.g., regulation of gene expression, purification, concentration, formulation, and long-term stabilization) to produce recombinant proteins of sufficient quantity and quality to meet clinical release criteria. At each of these steps, there is potential for the introduction of biochemical or biophysical modifications into the molecules that may influence the immunogenicity profile of the biologic product. While these aspects of protein production may not impact function of the therapeutic protein, modifications inherent in the manufacturing process can have a major impact on host immune responses. For example, consider the case of Erbitux, a protein with non-human type glycosylations that caused anaphylaxis in selected patients who had pre-existing antibodies targeting these carbohydrate structures [13] and [14]. Host cell proteins derived from recombinant protein-producing cell lines may co-purify with a therapeutic product to become part of the final formulation [15] and [16]. These impurities, even in small quantities, have the potential to stimulate an unwanted immune response. In at least one recent case, they induced anti-host cell protein antibodies and contributed to the suspension of a clinical trial [15] and [16].

Read the full paper here. 

If you'd like to join Annie at Immunogenicity for Biotheraputics this coming October 20-22 in Boston, as a reader of this blog, when you register to join us and mention code XP1938BLOG to save $100 off the current rate.

Follow the jump for the references.

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Celebrate Columbus Day! Register for Pharma and Healthcare Events Thru Monday and Save $300!

Register for any of the following IIR events and receive a $300 discount*

Mention code COLUMBUSLI when registering for each/any of the following:

-  Register here for IIR’s 15^th Annual Business of Biosimilars event taking place October 20-22, 2014 in Boston, MA, visit the website for full details.

-  Register here for IIR’s 15^th Annual Immunogenicity and Biotherapeutics event taking place October 20-22, 2014 in Boston, MA, visitthe website for full details.

-  Register here for IIR’s 10^th Annual Bioassays and Bioanalytical Method Development event taking place October 20-22, 2014 in Boston, MA, visit the websitefor full details.

Have any questions? E-mail Jennifer Pereira.

*This promotion is only valid October 10^th-13^th 2014. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IIR approval.

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Choosing a Technology for Immune Response Detection

This post was contributed by Russ Peloquin, SQI Diagnostics, Inc. 

Isotyping the ADA response to therapeutic proteins has become a significant aid for pharmaceutical and biotechnology companies who intend to bring their compounds to the FDA for approval. It’s also a key component for drug efficacy and ensuring the safety of patients worldwide.

The traditional method to obtain a full immune response to a given therapeutic would be to develop individual assays as standard ELISAs or individual ECL tests for each isotype and immunoglobulin subclass. The time and expense to do this can be extreme as well as too costly to outsource to a CRO.

However, the ability to multiplex these various isotypes and in following recent FDA recommendations, performing epitope mapping of the protein of interest, yields the highest quality results from a single sample in one or a few wells provides many advantages. The advantages include reduction in human error, variability from one assay to the next, significant reduction in labor and method development cost, as well as getting the most detailed information in a single reaction. Choosing a technology that has also shown to have superior drug tolerance with minimal matrix interference also deserves attention.

Automation is also a key driver for many laboratories’ decisions on which technology to choose. Although each project may require various throughput efficiencies at various stages in the development process, finding a technology that is automated provides a “grow into” model that can well suit a lab’s need for both high throughput needs, as well as lower throughput testing. A software that runs this automation and assay development that is 21 CFR part 11 should also be a strong consideration.

Automation also lends itself to the importance of judicious use of both therapeutic compound and study sample. That’s why the technologies being evaluated should only need a minimum amount of patient sample and drug of interest in order to yield the kind of information that a multiplex technology can produce from a single well. This is especially true for those drugs that treat rare diseases and those study samples that are in low volume, quantity, and availability.

Although certainly not required by regulators, a manufacturer that is a provider of clinical diagnostic IVD (in-vitro diagnostic) FDA-cleared kits and is cGMP and ISO-certified, gives researchers confidence in the technology’s robust QA and QC practices.

These ideas are not new to the bioanalytics arena, but are becoming increasingly more important in the evaluation of existing and new technologies to assess immunogenicity.  

You can hear more on the latest in the field at the Immunogenicity for Biotherapeutics conference. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

SAVE $100. Register here and use code XP1938BLOG.

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An Immunogenicity Veteran Shares His Experiences

Robert Kubiak’s professional journey has taken him from the University of Illinois at Chicago to the labs at Johns Hopkins to his current role with MedImmune.  The next stop for Robert will be the 15^th Annual Immunogenicity for Biotherapeutics where he’ll be leading a workshop on the Fundamentals of Immunogenicity Assessment. 

Robert will be sharing his experiences in his current role acting as head of a research group focusing on validation of bioanlytical methods.  In addition, he’s worked on development and validation of immunoassays at Tandem Labs, PPD and Meso Scale Discovery as well.  You’ll find some of those experiences cited in the work below:

-   Correlation of screening and confirmatory results in tiered immunogenicity testing by solution-phase bridging assays, Journal of Pharmaceutical and Biomedical Analysis

Commented by Coleman, D., Hendricks, R., et al, in 2013 Letter to the Editor “Regarding confirmatory immunogenicity assays” J. Pharm. Biomed. Analysis

Kubiak et al. present experimental and theoretical evidence that correlation of the screening and confirmatory results may be a general feature of the tiered approach when the same test platform is used for both screening and confirmatory assays. Presence of such correlation suggests that one of the tiers is redundant and that a single tier (e.g. screening only) can potentially yield the same results as the two-tiered assay.

-   Is The Tiered Immunogenicity of Biologics the Adequate Approach in Prenatal Development?, FutureScience

Following the arguments by Kubiak et al., Sauerborn proposes replacing the current tiered approach to immunogenicity testing with risk-based approach that follows fit-for-purpose strategy.

-   Challenges in keeping pace with immunogenicity advances throughout the clinical development of a biological therapeutic, FutureScience

     Authors of this paper argue that many immunogenicity assays tend to yield screening and confirmatory cut point values that are not reflective of biological variability in the study population. Such cut points, while mathematically correct, tend to result in high number of confirmed positive classifications in drug-naïve populations.

Don’t miss your chance to hear from Robert at IIR’s Immunogenicity for Biotherapeutics event. Join us October 20 – 22 in Boston, MA. Download the agenda to see the list of industry leaders presenting at this year’s event.

SAVE $100. Register here and use code XP1938BLOG

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How Can You Better Predict Immunogenicity?

Calculating immunogenicity directly effects your company's bottom line from drugs failing in the clinic to denying patients crucial treatment. Furthermore, the risk of adverse reactions is always existing when creating your product.  

Your company is searching for the Holy Grail to reduce or remove immunogenicity completely from its products. Assessment of immunogenicity continues to be hindered by complications such as pre-existing antibody, manual flow cytometry workflow, and drug interference while interpretation of data is complicated.

IIR's 15th Annual Immunogenicity of Biotherapeutics has a half day dedicated to predicting immunogenicity through a better understanding of underlying causes. You'll also learn about new procedures to adopt to save you money, time, and minimize the immunogenic potential in discovery.

Featured Sessions:

-  Next Generation Assays for Immunogenicity Prediction
    Pedro Paz, BR-US-Lead Discovery-Immunoassay/Immunoprofiling Group, Bayer HealthCare LLC

-  Prediction of Clinical Immunogenicity of Adnectins: Guiding Lead Optimization
    Daron Forman, Principal-Scientist, Bristol-Myers-Squibb

-  Improvement of a Sample Pretreatment Procedure for Immunogenicity Testing through Better Characterization of Cells, Positive Control Antibodies and Residual Drug Level
    Weifeng Xu, Research Investigator, Bristol-Myers-Squibb

Download the agenda to see what else is on tap.

Reserve your seat alongside your peers from Sanofi-Genzyme, Shire Human Genetic Therapies (HGT), Boehringer Ingelheim GmbH, and many more already confirmed!  SAVE $100 when you register here and use code XP1938BLOG.

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Improved Immunogenicity, Rapid Action of Anthrax Vaccine

Soligenix, a company developing vaccines for inflammatory diseases and biodefense, has released results demonstrating improved immunogenicity for VeloThrax™, the company’s anthrax vaccine.

VeloThrax™ is a proprietary recombinant Protective Antigen (rPA) vaccine of Soligenix.  It had been believed that VeloThrax™’s improved immunogenicity could result in a vaccine with the potential to be administered in fewer doses.  Recent results prove that this is in fact the case. 

Next generation anthrax vaccines had aimed for fewer vaccinations over a shorter period of time for both pre and post exposure use.  While the current vaccination requires as many as five administrations over an 18 month period, recent developments with VeloThrax™ show that it’s capable of producing the necessary immune response with only two doses in less than a month’s time.   

The enhanced vaccine was developed by stimulating receptor 4 (TLR-4) which plays an important role in the recognition of pathogens.  The stimulation of these receptors resulted in a boost to toxin neutralizing antibodies and triggered an elevation in immune responses in mice after just one immunization. 

The improved vaccine also proved to be stable at 40 degrees Celsius for up to three months as well as up to 70 degrees Celsius for one month.  This alleviates some of the burden in storing the vaccine. 

“We are very pleased that our enhanced anthrax vaccine, VeloThrax™, has demonstrated promising results indicative of rapid onset of protective immunity," explained Christopher J. Schaber, PhD, President & CEO of Soligenix. "These data demonstrate the potential of creating a rapidly acting anthrax vaccine with the ability to withstand temperature extremes thereby avoiding the need for cold chain management. We believe that stability at such elevated temperatures provides a distinct advantage over other anthrax vaccine technologies currently in development. Further, DNI rPA is highly immunogenic and offers the potential for complete immunization with just one or two doses.”

Schaber says he expects his company to continue to develop the vaccine.  The ultimate goal?  A position as an anthrax vaccine for “stockpiling by the US government”.

Want more on the latest in immunogenicity?  Join us at the Immunogenicity for Biotherapeutics conference this October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

SAVE $100. Register here and use code XP1938BLOG.

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1st Annual Women Leaders in Pharma and Biotech Dinner Series

IIR is committed to the support and growth of women in the life sciences industry and after much success with the annual Women's Clinical Leadership Forum at the Partnerships in Clinical Trials conference, we're thrilled to introduce the Inaugural Women Leaders in Pharma & Biotech Dinner Series:

October 20, 2014 | 6:00 – 8:30PM

Omni Parker House | Boston, MA

View the full agenda and speaker lineup.

Reserve your seat today.

We invite established leaders and up-and-comers in the pharmaceutical industry — both women and men of all levels — to attend.

Take part in lively and open conversation amongst leaders in the biomedical, bio-technology, diagnostic, health informatics, healthcare, medical device, and pharmaceutical sectors as they discuss strategies to help women work their way up the life sciences ladder.

Don’t forget to check out IIR’s other events in Boston this October 20-22:

• ·   15^th Annual Immunogenicity and for Biotherapeutics
• ·   10^th Annual Bioassays & Bioanalytical Method Development
• ·   15^th Annual Business of Biosimilars

Questions? Contact Marina Adamsky. 

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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 10^th 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 15^th Annual Immunogenicity for Biotherapeutics —learn more here.

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

Have any questions? Email Mike Madarasz.

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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 15^th Annual Immunogenicity for Biotherapeutics with a 30% discount off the standard rate!*

Register here to join us and mention code XP1938Cool to take advantage of this discount.  

The Immuno 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 10^th Annual Bioassays and Bioanalytical Method Development event—learn more here.

Have any questions? Email Mike Madarasz.

Follow us on Twitter

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Don't miss a thing. Sign up for our updates

*This promotion is only valid until August 15, 2014. Discount is not applicable to the Super Pass or Super Pass+

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New Tool to Help Analyze Immunogenicity

The FDA suspended a clinical trial for a Factor IX protein in 2012 but a new web-based tool may help avoid that very issue in the future.  In a collaboration between Dartmouth, University of Rhode Island and EpiVax Inc., researchers have developed a tool that will help manufacturers of protein-based therapeutics improve the safety of their manufacturing process.  The tool, known as CHOPPI (CHO Protein Predicted Immunogenicity), predicts the product associated impurities will trigger an adverse response in patients.

Protein therapeutics are frequently produced in host cells such as CHO cells. These hot cell proteins have been known to contaminate and ultimately damage the final product.  The immunogenicity of a CHO protein is generally low based on the fact that it’s very similar to a human protein. However, some believe that “any protein is potentially immunogenic”.  The tool is expected to help predict these immune responses of these host cell proteins and ultimately aid protein engineers in accurately assessing the purity of the final product.

Said Greg Paquette, Director of the Biotechnology and Medical Laboratory Science Programs, at URI, "The purity of these complex genetically-engineered therapeutic agents continues to be one of the biggest challenges for the biotechnology industry.”

More details can be found on this new tool in this Biotechnology and Bioengineering report.

Want more on the latest in immunogenicity?  Join us at Immunogenicity for Biotherapeutics conference this October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

SAVE $100. Register here and use code XP1938BLOG.

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Delivering Safe, Effective Therapeutics: IIR’s Immunogenicity and Bioassays Conferences

Two events, one goal.

Bring safe and effective therapeutics to the patient faster with IIR’s Immunogenicity and Bioassays conferences. 

The complexity of developing effective biologic therapeutics require adequate analytical methodology to characterize both their physicochemical properties and biological activity. Reducing the risk of triggering unwanted immune responses must be considered early on in drug development. The events focus on the current practice of comprehensive characterization of biotherapeutics from their discovery through all stages of their development.

IIR invites you to join us October 20-22, 2014 in Boston, MA for two co-located events: 15th Annual Immunogenicity for Biotherapeutics and 10th Annual Bioassays and Bioanalytical Method Development.

Download the brochure to find out how to register for one or both events and see for yourself why these are two can't miss events.

Download the Immunogenicity Brochure

Download the Bioassays Brochure

Now, you can save $100 on the current rate for each event. Register here with code XP1938BLOG for the Immunogenicity for Biotherapeutics conference.  Register here with code XP1969BLOG for the Bioassays and Bioanalytical Method Development conference. 

Questions? Comments? Reach out at MMadarasz@iirusa.com. 

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Celebrate America and Immuno! Register Thursday & Friday and save 30% off the standard rate!

Let freedom ring! Celebrate America’s freedom and YOUR freedom to register for IIR’s 15^th Annual Immunogenicity for Biotherapeutics with a 30% discount off the standard rate!*

Register here to join us and mention code XP1938JULY4 to take advantage of this discount.

The Immuno 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 10^th Annual Bioassays and Bioanalyitcal Method Development event—find out more here.

Have any questions? Email Jennifer Pereira.

*This promotion is only valid July 3 & 4, 2014

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Look Who’s Attending IIR’s Immunogenicity for Biotherapeutics Event Next Week!

IIR’s 14th Annual Immunogenicity for Biotherapeutics event is three weeks away! We invite you to join the leaders in biologics de-risking, immunoassay validation and predicting immunogenicity in novel, highly complex molecules. Below is just a small portion of who’s already signed up to be in Baltimore March 18-20th:

Companies in attendance include:
*Adnexus * Advion * Alexion Pharmaceuticals * Algorithme Pharma * Allergan * Amgen * Astellas Pharma Global Development * Aushon Biosystems * Avanza Laboratories * Bayer Healthcare * Biogen Idec * Boehringer Ingelheim Pharmaceuticals * Bristol-Myers Squibb * CDER * Charles River Laboratories * CIRION Clinical Trial Services * Clinigene International * Covance * Cytimmune Science * Eleven Biotherapeutics * Eli Lilly & Co. * Emory Children's Center * EpiVax * Food and Drug Administration * Frederick National Lab for Cancer Research * Functional Genetics * Genentech * Genzyme Corp * GlaxoSmithKline * Grifols * Hospira * Ipsen Group * Isis Pharmaceuticals * Janssen * KCAS Bioanalytical Services * Kirin Pharma * MedImmune * PerkinElmer * PharmaNet Development Group * PPD * QPS * Sandoz * Sanofi * Seattle Genetics * SQI Diagnostics * Teva Biopharmaceuticals * WIL Research * and more!

If you’d like to join these companies, the Immunogenicity for Biotherapeutics Conference is taking place next week, March 18-20, 2013, in Baltimore, MD. As a reader of this blog, you receive an exclusive discount of 15% off the standard rate when you register using code XP1838Link.

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Immunogenicity Session Spotlight: Highly Sensitive Non-Wash Immunoassays for Immunogenicity and PD/PK Studies

Severe adverse events to biologics are one of the very greatest fears facing the industry – even in a pre-marketing state, if they surface during clinical trials the public fear and reputational damage can be great enough to destroy the sponsor company (as was the case with the infamous “Elephant Man” trials in England). Since one of the quickest ways to predict and pre-empt adverse events is to detect anti-drug antibodies as early as possible and in the lowest amounts possible, this session will help experts in this field specifically target one of the greatest threats they face.  We'll be looking at this during the Highly Sensitive Non-Wash Immunoassays for Immunogenicity and PD/PK Studies session at Immunogenicity for Biotherapeutics this March!

Immunogenicity for Biotherapeutics will take place March 18-20, 2013 in Baltimore, Maryland. For more information on this session and the rest of the agenda, download the brochure. If you'd like to join us, as a reader of this blog when you register to join us and mention code XP1838BLOG, you'll save 15% off the standard rate!

Featured Session: Highly Sensitive Non-Wash Immunoassays for Immunogenicity and PD/PK Studies

Featured Speaker: Roger Bosse, Global Product Leader, Alpha Technology, PERKIN ELMER

About the session: Biotherapeutics often elicit immune responses and clinical consequences of anti-drug antibodies (ADA) can result in adverse events. The presence of ADA is a safety concern and must be evaluated and correlated with pharmacological or toxicological observations. The development of rapid, sensitive assays for ADA detection is essential. AlphaLISAÒ assays used to detect ADA in serum samples can detect ADA in the low ng/mL range, maintain excellent performance in serum and exhibit high drug tolerance.

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