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Cambridge Healthtech Institute’s Inaugural
Detection and Characterization of Particulates and Impurities
Rapid Tools and Strategies for Risk Assessment, Prediction and Characterization of Particles and Impurities from Products, Excipients and Processes
January 21-22, 2015


Particles and impurities can come from the products, any stage of processing or the packaging containers. The presence of particulates and impurities in the drug product can impact stability, safety, efficacy of the biomolecules and biologic products. Therefore, early understanding, detection and characterization of the impurities are critical to ensure safety and efficacy of the drug product for its intended duration of use. The Detection and Characterization of Particulates and Impurities conference provides a platform to explore novel tools and strategies to detect, characterize and carry out risk assessment of particles and impurities.

We invite you to join colleagues in this discussion of the key challenges and solutions for prediction, characterization, risk assessment of particles and impurities from products and processes, and see how experts like you are developing a scientifically sound formulation to deliver a safe and stable biologic drug product.

 

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Final Agenda 


TUESDAY, JANUARY 20

1:30 pm Conference Registration


BUZZ Sessions png

2:00 BuzZ Session A

3:00 Refreshment Break in the Exhibit Hall with Poster Awards

3:45 BuzZ Session B
(More Details >>)



4:30-5:00 Short Course Registration

5:00-8:00 Dinner Short Courses More Details >> 


WEDNESDAY, JANUARY 21

7:30 am Conference Registration and Morning Coffee


Strategies for Risk Assessment and Characterization of Impurities

8:15 Chairperson’s Opening Remarks

E. Neil LewisE. Neil Lewis, Ph.D., CTO and Director, Bioscience Development Initiative, Malvern Instruments






Keynote Presentation

8:20 Strategies for Characterization and Risk Assessment of Particles, Degradants and Impurities

Satish SinghSatish Singh, Ph.D., Research Fellow and Group Leader, Pfizer; Member, 787 Expert Panel, U.S. Pharmacopeial Convention (USP)

Considerable attention is paid to the development of appropriate process and product controls and specifications for biotherapeutics. However, the knowledge of the impact of these parameters on the efficacy, PK/PD, safety, immunogenicity may not always be available. The presentation will examine use of strategies to incorporate risk assessment tools to evaluate criticality and drive characterization efforts.


Orthogonal Toolbox for DETECTION AND CHARACTERIZATION of Subvisible Particles

9:00 Advances in the Detection and Characterization of Subvisible and Visible Particles and Other Aggregates

Andrea HaweAndrea Hawe, Ph.D., Chief Scientific Officer, Coriolis Pharma

The talk gives an overview on current trends for aggregate, subvisible particle and visible particle characterization of biologics. Analytical methods that are routinely used for the quantification and partly also the identification of aggregates and particulates, such as dynamic light scattering (DLS), nanoparticle tracking analysis (NTA), flow field flow fractionation techniques (AF4/HF5), analytical ultracentrifugation (AUC), resonant mass measurements (RMM), flow imaging microscopy, light obscuration and semi-automated visual inspection are presented.

9:30 Stability Challenges for Protein Therapeutics: Characterizing Aggregation Propensity and Further Formation of Subvisible Particles

Joël RichardJoël Richard, Ph.D., Vice President, Peptides, CMC & Engineering, Ipsen

The talk focuses on the appropriate biophysical methods to characterize protein aggregation propensity, show structural modifications of proteins, study the effect of excipients on these modifications and the subsequent mechanism of formation and characterization of subvisible particles. These techniques appear as powerful orthogonal tools to study protein structure alteration and aggregation, which are among the most striking issues, also potentially triggering immunogenic reactions. Clinical impact will also be discussed, as a potential safety issue.

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

10:50 Factors Influencing the Sizing and Counting of Subvisible Particles by Orthogonal Methods

Richard CavicchiRichard Cavicchi, Ph.D., Physicist, Bioprocess Measurements Group, National Institute of Standards and Technology

We have used a microfluidic device designed to perform simultaneous flow imaging (FI) and electrical sensing zone (ESZ) measurements to investigate causes for variation in the results from these subvisible particle characterization methods. We compare highly monodispersed, photolithographically produced rods and disks as well as protein particles to illustrate the large influence of shape and porosity. Results are compared to measurements on commercial instruments based on FI, ESZ, and light obscuration.

11:20 Identification and Characterization of Particles in Biopharmaceutical Formulations

Miguel SagguMiguel Saggu, Ph.D., Associate Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

Subvisible particles in biopharmaceutical formulations may impact potency and immunogenicity of biotherapeutics. Detection, quantification and identification of particles in high concentration formulations represents a challenge to date, in particular in the size range between 0.1 – 10 µm. Case studies to overcome these technical difficulties are presented here.

11:50 Polysorbate Degradation and Particles in Biopharmaceutical Formulations: Analytical Method to Characterize Particulates and Degradants

Anthony TomlinsonAnthony Tomlinson, Research Associate, Late Stage Pharmaceutical Development, Genentech, Inc.

Polysorbates are commonly used surfactants in the formulation of biopharmaceuticals. It has been observed that upon long-term storage of formulated products, these surfactants can degrade into insoluble products (including free fatty acids) which can lead to increased subvisible and visible particle counts. A method for detection and quantification of total free fatty acids in placebo and active formulations will be presented here along with related case studies. Furthermore the utility of the method for identification and characterization of insoluble particle composition is discussed.

12:20 pm Sponsored Presentation (Opportunity Available)

12:50 Session Break

1:00 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own


Rapid Screening of Impurities from Product and Excipients

2:00 Chairperson’s Remarks

Ajit S. Narang, Ph.D., Principal Scientist, Drug Product Science & Technology, Bristol-Myers Squibb Co.

2:05 Mechanism of Protein Aggregation and Sustained Effect of Shear During Drug Substance Manufacture on Drug Product Stability

Ajit S. NarangAjit S. Narang, Ph.D., Principal Scientist, Drug Product Science & Technology, Bristol-Myers Squibb Co.

Emerging data suggests that aggregation instability of a ready-to-use protein solution drug product may be linked to the shear forces experienced by the protein during downstream purification. Sustained conformational changes due to shear during processing may contribute to long-range hydrophobic protein-protein interactions in protein solutions. These interactions manifest in changes in the physicochemical properties of proteins including viscosity and hydrodynamic diameter, in addition to protein aggregation during accelerated stability testing. These observations provide an experimental framework to develop an early predictor of aggregation instability.

2:35 Understanding Protein-Surfactant Interactions at Air-Water and Water-Solid Interfaces

Alfredo R. NarvaezAlfredo R. Narvaez, Ph.D., Manager, Diluent Research & Formulation Group, Global Process Design R&D, Abbott, Inc.

Modulation of protein presence at surfaces is of paramount importance for performance of reagents used in the clinical laboratory. In this work, protein displacement by surfactants was characterized at the air-water interface via oscillatory and dilational rheology and at the water-solid interface by the quartz crystal microbalance method. Discriminatory interactions between proteins and surfactants and the importance of surface properties are discussed.

3:05 Detecting Irreversible Aggregate Formation of an Antibody during Downstream Processing

Joy ChenJoy Chen, Ph.D., Scientist, Process Development Analytical, OncoMed Pharmaceuticals, Inc.

Analyzing in-process samples is important for process development of antibodies in order to achieve higher yield and acceptable product quality. By a variety of analytical methods including SEC and ion exchange chromatography, we observed standard low pH elution buffers of protein A chromatography can cause irreversible aggregate formation which appeared to be induced by antibody denaturation. This talk describes characterization efforts that facilitated changes in downstream processing to decrease aggregate formation and achieve higher product yield.

3:35 A High-Throughput Coupled Methodology for Quantitation of Iso-Aspartate Formation in Proteins and Peptides

AasthaPuriAastha Puri, M.Sc., Associate Scientist II, Drug Product Science & Technology, Bristol-Myers Squibb Co.

Formation of isoaspartate arising from a spontaneous asparagine deamidation or aspartate isomerization is one of the most common non-enzymatic pathways of chemical degradation of protein pharmaceuticals. This presentation will discuss degradation mechanism and formulation strategies to mitigate isoAsp formation. Also, the utility of a fluorescence-based high throughput assay utilizing protein isoaspartyl methyltransferase assay to quantitate isoAsp in four protein/peptide formulations containing active species of varying scaffolds will be presented.

4:05 Refreshment Break


4:30 Plenary Keynote Session

From Yeast to the Brain: Advances in Proteomics (More Details >>

John YatesJohn R. Yates, Ph.D., Ernest W. Hahn Professor, Chemical Physiology and Molecular and Cellular Neurobiology, The Scripps Research Institute

 

5:30-7:00 Reception in the Exhibit Hall with Poster Viewing



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