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CE Pharm 2018: Roundtable Discussions
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The roundtable sessions are truly interactive workshops to connect and discuss real issues with peers. These sessions were designed to be informal (but structured) discussions on topics which are of interest to participants but were not able to be incorporated into the other sessions within the program.

CE Pharm 2018 held two roundtable sessions where attendees were able to interact and discuss the following topics.  If you missed a topic that interested you and want to see what was discussed, please use the links below to see the notes.


Table 1: CE-MS: Unexploited Opportunities in Process Development

Session 1

Facilitator: Mei Han, Amgen Inc.

Scribe: Yunan Wang, Amgen Inc.


Session 2

Facilitator: Göran Hübner, Boehringer Ingelheim Pharma GmbH & Co. KG

Scribe: Tara Enda, Bristol-Myers Squibb Company

Scope:
Capillary Electrophoresis-Mass Spectrometry (CE-MS) has become an increasingly important technique over the last two decades for biopharmaceutical industry with the improvement of the CE-MS interface and MS instrumentation. CE-MS is an orthogonal technique and provide complementary information to LC-MS. For example, CE-MS can provide intact and bottom up protein characterization, charge variant identification, glycoprotein profiling, protein-ligand complex, protein integrity in vitro and in vivo, as well as in biomarker characterization. This table will focus on the “Unexploited Opportunities in Process Development” discussions and explore the future directions.

To view the full abstract and discussion notes, click here.


Table 2: CE in New Emerging Therapeutic Areas (Gene Therapy, Oligonucleotides)

Session 1

Facilitator: Richard Rustandi, Merck & Co., Inc.

Scribe: Xiaoping He, Pfizer, Inc.


Session 2

Facilitator: SungAe Park, Samsung Bioepis Co., Ltd.

Scribe: Ashraf Ali, Inha University

Scope:
In this roundtable we will discuss about your experience with CE in new emerging therapeutic and vaccine areas (gene therapy, Oligonucleotides, mRNA). Plasmid DNA is being used as vector for gene technology to transfer genes into eukaryotic cells. Use of plasmid DNA vectors for gene delivery in gene and cell therapy and for nucleic vaccination has required a tool such as CGE to determine and evaluate product quality during production (and lot release) and also in the moment of application with such non-viral vector systems. Since Gene Therapy and mRNA-based vaccine have been interest in many pharmaceutical companies, we need good analytical processes to detect purity and heterogeneity of delivering vectors.

To view the full abstract and discussion notesclick here.


Table 3: Real Time Release/PAT, How Does CE Fit In?

Session 1

Facilitator: Lars Geurink, Janssen Infectious Diseases and Vaccines

Scribe: Ewoud van Tricht, Janssen Infectious Diseases and Vaccines


Session 2

Facilitator: Lars Geurink, Janssen Infectious Diseases and Vaccines

Scribe: Ewoud van Tricht, Janssen Infectious Diseases and Vaccines

Scope:
Process Analytical Technology (PAT) is a system for designing, analyzing and controlling pharmaceutical manufacturing processes through measurements of critical quality and performance attributes. Raw and processed materials are tested to ensure final product quality. For that reason, PAT can be used to release the product at the time of production, hence real time release. The idea behind PAT is to become more efficient by reduction of over-processing, sample motion, sample and product storage. In this roundtable, we would like to discuss the way PAT could be preferred over quality by testing and the role of CE in this.

To view the full abstract and discussion notesclick here.


Table 4: CE Troubleshooting: Lessons Learned

Session 1

Facilitator: Tom Niedringhaus, Genentech, a Member of the Roche Group

Scribe: Sarah Lum, University of Notre Dame


Session 2

Facilitator: Kathir Muthusamy, Regeneron Pharmaceuticals, Inc.

Scribe: Theresa Hassett, Seattle Genentics, Inc.

Scope:
Capillary electrophoresis (CE) methods have become an increasingly essential part of the analytical control strategy throughout the biopharmaceutical industry. Automated instrumentation, powerful separation efficiency, low sample requirements, and fast analysis times have made CE a great analytical tool for drug characterization. However, expanded use in industry requires a new generation of CE users to rapidly become experts in utilizing and troubleshooting these methods. While CE methods must meet a certain level of robustness and consistency, troubleshooting is still required to resolve unexpected method performance issues. Various separation modes such as cIEF, CE-SDS, CZE, and CE-MS all have their own unique challenges when performed on different instrumentation and platforms. The goal of this roundtable discussion is to connect new and experienced CE users in order to share commonly- observed issues and troubleshooting lessons learned.

To view the full abstract and discussion notesclick here.


Table 5: Unmet Needs in Analytical Characterization: Chances for CE (Non MS Applications)

Session 1

Facilitator: Hermann Wätzig, University of Braunschweig

Scribe: Gordon Freckleton, Celgene Corporation


Session 2

Facilitator: Mark Lies, SCIEX

Scribe: Nate Lacher, Pfizer, Inc.

Scope:
Challenges still exist in our industry for characterizing complex pharmaceutical products. This roundtable aims to discuss where gaps currently exist and identify potential solutions to allow for improved characterization solutions. In some cases, this may require the development of new methodologies for existing instrumentation or could require development of completely new instrumentation with enhanced flexibility to allow the researcher to work on whatever type of molecule is in their portfolio.

To view the full abstract and discussion notesclick here.


Table 6: CE Methods Meet Contract Labs - Challenges and Successes

Session 1

Facilitator: Abbie Esterman, Bristol-Myers Squibb Company

Scribe: Nomalie Jaya, Seattle Genentics, Inc.

Session 2

Facilitator: David Fischer, Genentech, a Member of the Roche Group

Scribe: Elisabeth Krug, Eli Lilly and Company

Scope:
CE-methods are robust methods, aren’t they? Why does it feel that we are having less success in transferring the methods? What could be done to avoid failures?

To view the full abstract and discussion notesclick here.


Table 7: Strategies for Moving CE-based Charge Methods into Late Development or Commercial Facilities

Session 1

Facilitator: Nate Lacher, Pfizer, Inc.

Scribe: Eric Ong, Regeneron Pharmaceuticals, Inc.


Session 2

Facilitator: Tim Blanc, Eli Lilly and Company

Scribe: Nomalie Jaya, Seattle Genentics, Inc..

Scope:
Today complex bio-pharmaceuticals are rapidly moving through the pipeline to the approval stage and, consequently, that necessitates the expedited development and seamless transfer of challenging molecule-specific methods to commercial facilities. As a product advances through the various development stages, the methods often become more product specific and less platform-like. With increasing complexity and less familiarity with product specific methods the transfers to commercial facilities are often more difficult. Further, product characterization and profile identification is needed to support a licensing application. This roundtable aims to discuss the challenges with peak characterization and transfer of CE-based charge methods to multiple testing facilities as a project progresses through clinical development to commercialization. Attendees to this roundtable will increase their understanding of CE-specific method lifecycle issues including what has worked, or not worked, in the past and potential/emerging issues to watch out for in the future.

To view the full abstract and discussion notesclick here.


Table 8: Validation Strategies and What Method Parameters to Focus On

Session 1

Facilitator: Maria Schwarz, Solvias AG

Scribe: Steffen Kiessig, F. Hoffmann - La Roche Ltd.


Session 2

Facilitator: Maria Schwarz, Solvias AG

Scribe: Steffen Kiessig, F. Hoffmann - La Roche Ltd.

Scope:
Analytical method validation is a crucial part of the method life cycle with respect to pharmaceutical products. In general, method validation is performed according to the ICH guideline Q2(R1) “Validation of Analytical Procedures: Text and Methodology”. The guideline describes the procedure for the evaluation of required validation characteristics for identity tests, impurity tests (quantitative and limit) and assays. However, considering all analytical test methods applied in routine analysis of pharmaceutical products, particularly biopharmaceuticals (release and stability testing) it becomes evident that a high number of these methods are based on the determination of relative peak areas, i.e. area percentage methods. Since these methods cannot be allocated to any of the method types mentioned in the ICH guideline, they are usually treated as quantitative methods. As such, validation characteristics like linearity, accuracy and LOQ are usually assessed based on absolute peak areas rather than relative. Since the absolute peak areas do not correspond to the analytical result of area percentage methods, the common validation procedures somehow reveal gaps. This table will discuss the current validation procedures, which validation parameters to focus on and suitable suggestions for area percentage methods.

To view the full abstract and discussion notes, click here.


Table 9: Platform Methods - How Much Optimization Should be Necessary?

Session 1

Facilitator: Elisabeth Krug, Eli Lilly and Company

Scribe: Tim Riehlman, Regeneron Pharmaceuticals, Inc.


Session 2

Facilitator: Kevin Strozyk, Seattle Genentics, Inc.

Scribe: Abbie Esterman, Bristol-Myers Squibb Company

Scope:
The pharmaceutical and biopharmaceutical industries strive to develop new products to improve the lives of patients. As such, there is a continuous effort to reduce the time and expense associated with development in order to introduce drugs to the market efficiently. Analytical method development is a balancing act, juggling demands to meet faster timelines while still producing high quality methods. Platform methods/ first-to-try conditions may be an answer to the challenge for most molecules within molecule platforms.

Utilizing platform methods to monitor product quality and process consistency is a common strategy to streamline early phase development efforts. The platform concept requires basic understanding of the product and assumes similar molecules will behave similarly under specified method conditions. As platform methods become more common in the industry, it is important to contemplate how much optimization is necessary to ensure the method is suitable and the results are fit for purpose.

To view the full abstract and discussion notesclick here.


Table 10: How Does the Emergence of the Multi-Attribute Methods (MAM) Impact the Role of CE?

Session 1

Facilitator: Göran Hübner, Boehringer Ingelheim Pharma GmbH & Co. KG

Scribe: Zoran Sosic, Biogen


Session 2

Facilitator: Zoran Sosic, Biogen

Scribe: Jonathan Gilroy, Aptevo Therapeutics

Scope:
Recently, mass spectrometry-based methods intended to simultaneously monitor product quality attributes have been introduced to more deliberately assess the quality all along biopharmaceuticals manufacturing processes. As such, these multi-attribute methods (MAM) could offer potential to replace several traditional chromatographic and electrophoretic assays, including CE-based methods, currently used for characterization and release of biopharmaceuticals. This roundtable aims to discuss both the potential scope of MAM methods and challenges for their implementation in manufacturing and QC environment.

To view the full abstract and discussion notesclick here.


Table 11: Experience with Native Fluorescence-based ICIEF: Pro & Cons

Session 1

Facilitator: Kevin Strozyk, Seattle Genentics, Inc.

Scribe: SungAe Park, Samsung Bioepis Co., Ltd.


Session 2

Facilitator: Tom Niedringhaus, Genentech, a Member of the Roche Group

Scribe: Julia Kahle, University of Braunschweig

Scope:
UV absorbance at 280 nm has been the conventional method of detection utilized by commercially available imaged capillary isoelectric focusing (iCIEF) instrument platforms since inception (e.g. iCE280 and iCE3 from ProteinSimple). With recent advances in iCIEF instrumentation, such as the Maurice, iCIEF enthusiasts now have the capability to measure the UV absorbance of an isoelectrically focused protein as well as the native, or intrinsic, fluorescence of that protein. As with any new tool in the analytical toolbox, many questions accompany the excitement. This roundtable aims to highlight recent experiences with native fluorescence-based iCIEF and discuss the pros and cons surrounding the detection’s capability.

To view the full abstract and discussion notesclick here.


Table 12: Vendor Engagement and Communication: Striving Towards Successful Collaborations and Information Sharing

Session 1

Facilitator: David Fischer, Genentech, a Member of the Roche Group

Scribe: Theresa Hassett, Seattle Genentics, Inc.


Session 2

Facilitator: Jeff Beckman, Bristol-Myers Squibb Company

Scribe: Handy Yowanto, SCIEX

Scope:
In McKinsey & Company February 2013 article, The power of successful supplier collaboration, McKinsey surveyed more than 100 large global companies on supplier and vendor collaboration practices and found that companies with advanced collaboration capabilities tend to outperform their peers and beat industry trends by 2X in growth metrics. Their vendors benefit as well as they become more cost competitive, improve their core capabilities and develop new innovative products. As Biopharma companies develop new therapeutics, there is a need for analytical instrument vendors to develop new products that can address these new compounds.

The scope of this discussion is to find ways to improve collaboration practices between Biopharma analytical groups and vendors of analytical instruments. The focus will be to discuss the varying types and objectives of these collaborations. their value, and how to gain access to critical information and resources to achieve successful outcomes for both parties as well as for the biopharma analytics industry in general.

To view the full abstract and discussion notesclick here.


 

 

 

 

 

 

 

 


 

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