The Bioprocessing Summit

Cambridge Healthtech Institute’s Inaugural
Early Analytical Development for Biotherapeutics
Optimizing the Selection and Performance of Preclinical Analytical Studies
Part of CHI’s 6th Annual The Bioprocessing Summit

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


The analytical steps conducted in preclinical development following the handoff of a lead candidate are vital on many levels in determining the fate of that program. This complex effort shapes the optimization of the new product, requires the use of expensive and scarce resources and supports the voluminous regulatory filing that is the early IND application. It is imperative that companies reach this important milestone as quickly and efficiently as possible, while positioning the organization to move rapidly into the GMP production needed for early phase clinical trials.

Early Analytical Development for Biotherapeutics will present best practice case studies of how industry companies have approached the most important analytical studies occurring during this stage, offering valuable information you can apply right away to your own preclinical programs.


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


Suggested Short Course*

Analytical Strategies for Comparability in Bioprocess Development 

Tuesday, August 19, 6:00 – 8:30 pm


*Separate registration required


Wednesday, August 20

7:00 am Registration and Morning Coffee


BUILDING THE EARLY ANALYTICAL STRATEGY

8:05 Chairperson’s Remarks

IyerVidyashankaraVidyashankara Iyer, Ph.D., Scientist, Formulation Sciences, MedImmune


8:15 Keynote Presentation

Building a Robust Early Stage Analytical Characterization Process at the Discovery Research Stage

Laura LinLaura Lin, Ph.D., Director, Biophysics, Analytics, & Bioconjugation, Biotherapeutics R&D, Pfizer

The presentation will outline a robust, micro-scale molecular assessment process we have established in the Discovery Research space at Pfizer to enable the design, triage, and optimize Biotherapeutic leads with optimal physicochemical properties before they reach the Development phase, thereby reducing the level of risk and cycle time.  Correlation between the early stage assessment and later stage evaluations will be discussed. 


9:00 Application of a Simple and Fast Platform Method for DTPA in the Investigation of Co-Concentration of DTPA Due to the Donnan Effect during Processing of a Therapeutic mAb

JasonHuangJason Huang, Ph.D., Senior Research Investigator, Analytical and Bioanalytical Development, Bristol-Myers Squibb

The chelating agent diethylene triamine pentaacetic acid (DTPA) is used in biologics formulations to prevent oxidation induced by metal ions and therefore improve protein stability. This presentation shows how a simple and fast platform method was applied for in-process monitoring of DTPA during biologics formulation development. The data obtained by this method demonstrated that there was a co-concentration of DTPA due to the Donnan effect during tangential flow filtration of a therapeutic mAb formulation.

9:30 Applying Inputs from Research Stage Studies and Developability Evaluations to the Early Analytical Strategy

MatthewMyersMatthew Myers, Associate Scientist, Sterile Products Analytical Development, Merck





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

10:45 Development of an Early Analytical Strategy for a Novel Biotherapeutic

PatriciaLowdenPatricia Lowden, Scientist, Protein Production and Analytics Department, Eleven Biotherapeutics

EBI-005 is a novel cytokine receptor antagonist for IL-1R and is currently in phase III development for dry eye disease. EBI-005 was characterized biochemically and biophysically at the earliest stages of development. Methods of characterization included CIEX- HPLC, RP-HPLC, SEC, SDS-PAGE, peptide mapping, DSF, CD and SIC. Extensive early characterization work has facilitated both purification process development, and formulation development. The extensive characterization has also led to constructive dialogue with regulators through the development stages.

11:15 Developability Evaluation for Novel Molecule Formats

IyerVidyashankaraVidyashankara Iyer, Ph.D., Scientist, Formulation Sciences, MedImmune

Risk assessment of combination products and novel protein molecules is important in the early stages of product development. A robust developability screen could flag potential problems with these novel formats. These issues include stability issues intrinsic to the proteins involved, protein-protein interactions in multi-protein drugs, adjuvant compatibility of protein sub-unit vaccine antigens and analysis of protein degradation in a mixture of proteins. These hosts of additional issues add complexity to product development. Identification of these problems early on is desired so that mitigation strategies can be implemented. This presentation covers specific issues in developability that may help accelerate and de-risk development timelines for novel formats of biomolecules.

11:45 Presentation to be Announced

Yan Wang, Ph.D., Scientist, Analytical Development, Biogen Idec

12:15 pm Enjoy Lunch on Your Own

1:30 Session Break


HIGH-THROUGHPUT ANALYSIS IN EARLY DEVELOPMENT

1:55 Chairperson’s Remarks

JasonHuangJason Huang, Ph.D., Senior Research Investigator, Analytical and Bioanalytical Development, Bristol-Myers Squibb




2:00 High-Throughput Heterogeneity Analysis of Antibodies and Antibody-Like Molecules

MelissaGeddieMelissa Geddie, Ph.D., Senior Scientist, Merrimack Pharmaceuticals

Multispecific antibodies and antibody-like molecules broaden the therapeutic application of IgGs, but they can be challenging to engineer and manufacture. To address this we first use a network biology approach to identify key design parameters followed by iterative rational engineering, rapid design cycles and high-throughput screening assays to reduce heterogeneity. Our approach selects for potential therapeutic candidates with robust pharmaceutical properties.

2:30 Rapid Deployment of Analytical Methods during Early Stage Biologics Development

MarcVerhagenMarc Verhagen, Ph.D., Director, Biochemical Method Development, Allergan

Efficient support of process and formulation development activities during early stage programs require a variety of methods for monitoring key attributes of the compound of interest in samples with widely varying matrices. Approaches to establishing early stage methods, real time assessment of suitability for use for different sample types, and handling of documentation associated with the initial stages of the method lifecycle will be discussed.

3:00 Efficient Evaluation of Product Quality Attributes during Early Development

PeterVandebergPete Vandeberg, Ph.D., Director, Analytical Development, Grifols

During early phase development, prioritization is placed on methods needed to support process development and pre-clinical studies. Focus is generally placed on methods to measure activity and purity. Methods should have quick turn around times and low manpower requirements. Analytical characterization data gathered should be positioned to file the IND and aid in further development.

3:30 Refreshment Break

4:15 High-Throughput Analytical Platforms to Assess Product Quality Attributes at Early Stage of Cell-Line Development

ShashiPrajapatiShashi Prajapati, Ph.D, Senior Scientist, Biogen Idec

Here we present high-throughput (HTP) analytical assays to facilitate rapid product quality using 96-well plate formats. These HTP product quality assays include HTP protein quantitation followed by HTP protein purification and product quality analyses. With these HTP analytical product quality assays, we can assess product quality in the early stage of clone screening, as well as expedite the cell-line and process development.

4:45 Automation of Bioanalytical Ligand-Binding Assays Using Modular Robotic Scripts as a Generic Template in Support of Discovery Biotherapeutic Programs

JiaDuoJia Duo, Ph.D., Research Investigator, Analytical and Bioanalytical Development, Bristol-Myers Squibb

Traditional automation-assisted ligand-binding assays (LBAs) use assay-specific scripts requiring labor-intensive script writing and user training. Major nonspecific script modules were developed to facilitate automated sample preparation and LBA procedures. The modular design of general automation scripts allows users to assemble automated assays with minimal script modification. Results demonstrate that the modular scripts provide flexibility in adapting to various LBA formats and significant time savings in script writing and scientist training.

 5:15 Networking Reception in the Exhibit Hall with Poster Viewing 




6:30 End of Day


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