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PEGS Summit 2012
30 April 2012
4 May 2012
Boston, USA
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ANALYTICAL STREAM 5th Annual Protein Aggregation and Stability in Biopharmaceutical Products May 2 - 3The study and prevention of protein aggregation and its consequences represents one of the most demanding tasks in biomedical research and pharmaceutical manufacturing today. Whether one's interests lie in protein characterization or analytics, the study of protein aggregation-induced adverse effects or immunogenicity, or work in formulation and process development for protein-based therapeutics, "Protein Aggregation and Stability in Biopharmaceutical Products" will provide a comprehensive real-world perspective on this challenging arena. Day 1 | Day 2 TUESDAY, MAY 1 6:00-9:00 pm Recommended Dinner Short Course* *Seperate registration required. WEDNESDAY, MAY 2 7:00 am Registration and Morning Coffee ANALTYICAL METHODS: DETECTION AND CHARACTERIZATION 8:30 Chairperson's Opening Remarks Vineet Kumar, Ph.D., Senior Research Scientist, Global Formulation Sciences, Parenterals, Abbott » 8:40 Keynote Presentation Causes and Control of Aggregation and High Viscosity in High Concentration Formulations At high concentrations, the solution properties of protein formulations are dominated by the colloidal properties of the protein. These colloidal properties arise from weak forces between all of the solution species. The weak forces are electrostatic and electrodynamic in origin, with charge-charge interactions being the longest range and Van der Waals interactions the shortest range force. These weak forces give rise to solution nonideality, a readily measured quantity. Likewise, protein charge is a readily measured quantity that is important to the solution nonideality. This talk will cover: 1) Weak forces and concentrated solutions: definitions, nonideality and nonideality determination; 2) Measuring the charge on proteins: methods, accuracy and meaning; 3) Monoclonal antibody charge: an example of Nature's perverse sense of humor; 4) Charge and solution behavior: Charge may help or it may hurt solution properties; 5) The role of charge in aggregation; 6) The importance of protein dipole moment measurement. Sponsored by The emergence of protein therapeutics has created a demand for new analytical methods because unlike small molecule pharmaceuticals their efficacy is also determined by their high order structure and conformation. Raman spectroscopy in combination with DLS can be used to measure these properties using small amounts of material under typical formulation conditions. 9:40 Characterization of Protein Aggregation in a Fusion Protein The mechanisms behind non-native aggregation of recombinant Fc-fusion protein therapeutics from mammalian expression systems was studied specifically in relation to highly glycosylated proteins. Both chromatographic as well as higher order structural tools were used to define protein changes that may influence aggregation kinetics. In addition, the impact of glycosylation state on aggregation was also investigated. 10:10 Coffee Break in the Exhibit Hall with Poster Viewing 11:10 Sub-Visible Particle Detection in a High Concentration Protein Formulation The development and qualification of a method for subvisible particle counting is described for a high concentration protein formulation. Challenges for this method include the concentration of the product and the prefilled syringe container-closure system, leading to the presence of silicon oil droplets in the samples. Significant development was carried out to ensure that the resulting method was robust, reproducible, and suitable for use in a QC environment. 11:40 Novel Mass Spec-Based Approaches to Characterize Aggregation and Association of Protein Therapeutics Traditionally, aggregation has been monitored using relatively low-resolution techniques that do not characterize the process at desired detail. An alternative is now provided by electrospray ionization mass spectrometry (ESI MS). We will discuss several recent developments that allow ESI MS to be used both in combination with classical tools and as a stand-alone technique for characterization of both soluble protein aggregates and products of ordered protein association. Sponsored by Paul D. Davis, Ph.D., President & CEO, Quanta BioDesign, Ltd. Quanta has generated an abundance of data in working with proteins which suggests that its dPEG® technology could be a simple, yet flexible solution to solving or affecting many of the aggregation issues that are extant in biologics. In support, there are a number of key published references using the dPEG® technology to solve a wide range and variety of scenarios related to solubility, aggregation and elimination of non-specific binding. Data demonstrating these positive attributes of dPEG®s, as well as data on binding/activity and immunogenicity will be discussed. 12:40 Luncheon Presentation (Sponsorship Opportunity Available) Understanding Mechanisms Of Aggregation: Extrinsic Factors And Excipients 1:30 Chairperson's Remarks 1:35 Mechanistic Links between Soluble Aggregate and Subvisible Particle Formation in Protein Therapeutics Robert Simler, Ph.D., Staff Scientist, BioFormulations Development, Genzyme Although a significant amount of recent work has focused on the quantification and characterization of subvisible particles, little is understood about the mechanism which links their formation to that of smaller, soluble aggregates. This talk will focus on agitation experiments designed to generate subvisible particles and soluble aggregates in an effort to identify a mechanistic relationship between the two higher order species. Practical consequences of this mechanism as they relate to formulation development will also be discussed. » 2:05 Featured Presentation High Concentration Protein Formulations: Complexity of the Stabilization and/or Destabilization Effects of Sugars/Polyols on Aggregation Sugars are widely used in low/high concentration protein formulations. In fact, more than 70% marketed protein formulations have sugars as stabilizers and/or tonicity modifiers. The talk will focus on the stabilization/destabilization effects of sugars and the strategies to select the best and the most useful poyol for the formulation. Audience will learn methods to appropriately select and/or deselect sugars especially for high concentration formulations. 2:35 Sponsored Presentations (Opportunities Available) 3:05 Refreshment Break in the Exhibit Hall with Poster Viewing 3:50 Problem Solving Breakout Discussions 4:50-6:00 Networking Reception in the Exhibit Hall with Poster Viewing Day 1 | Day 2 |
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