Day 1 | Day 2 | Download Brochure
TUESDAY, APRIL 13
7:30am Registration & Morning Coffee
8:30 Chairperson’s Opening Remarks
Boro Dropulic, Ph.D., President & CEO, Lentigen Corporation
OPENING KEYNOTE PRESENTATION
8:35 cGMP Manufacturing- Validation 101 – A Primer
Kim Wong, Ph.D., Director, Facilities & cGMP Support, Process Development, sanofi pasteur
Validation is a key support pillar of current Good Manufacturing Practices. It contributes to the assurance that biopharmaceutical products are produced in a consistent and reproducible manner that provides the safety and critical quality attributes desired. Similar to all drug development activities, validation is performed as a balance between apparent competing forces including regulatory compliance, speed to market and limitation of resources. Incorporation of initiatives such as risk management and QbD also add to the changing landscape. The basics of validation and how to perform validation within this dynamic and evolving environment will be discussed.
9:05 Development of Smarter Tools: Faster Analytics for Biotherapeutics
Nathan A. Lacher, Ph.D., Principal Scientist, Pfizer, Inc.
To meet the changing product development requirements and to support a developing pipeline with increasing complexity, various strategies have been implemented to reduce the resource requirements. One strategy includes reducing the sample preparation and analysis time by utilizing enhanced analysis methodology. Another approach was to implement a phase appropriate strategy for the verification, qualification, and validation of analytical technology. In this presentation, the enhanced analytical methodology as well as components of the phase appropriate strategy will be discussed.
9:35 Streamlining Technology Transfer for Biologics: Maximizing the Do’s and Minimizing the Don’ts
Annie Van Broekhoven, Ph.D., Vice President, Biologicals, Innogenetics Biologicals
Making use of various case studies, this presentation will focus attention on critical factors and practical methods to ensure efficient technology transfer from client to CMO. Possible obstacles caused by both parties, including non-technical pitfalls such as culture and communication differences, documentation gaps, contractual shortcomings, and unrealistic timings, will also be highlighted. Possible solutions will be offered.
10:05 Speed Networking Session -- Bring Your Business Cards!
10:30 Networking Coffee Break, Poster and Exhibit Viewing
11:10 Compliance and Regulatory Issues for Scaling Up Biopharmaceuticals
Jeanne M. Novak, Ph.D., CEO, CBR International
11:40 Darwinism in the BioPharmaceutical Industry: Process Changes as Part of the Evolution of a Process
Dagmar Meissner, Owner & Founder, BioProcess Solutions
As a biopharmaceutical process is scaled-up for clinical or commercial production, the company is often constrained by financial and regulatory requirements. Due to this circumstance along with the fact that science is continuously advancing, process changes are an inevitable reality in this industry in order to ensure the consistent production of a safe and efficacious drug, cost-effectively. This presentation will discuss from a process as well as a regulatory perspective the reasons and consequences of implementing process changes, as well as the ways of minimizing such changes through QbD.
12:10pm Luncheon Presentation or Lunch on Your Own
(Opportunity available, please contact Jon Stroup at jstroup@healthtech.com)
2:00 Chairperson’s Remarks
David Clark, Ph.D., Global Head of Pharma Pilot Plants, Centocor / J&J
Featured Presentation
2:05 Determine the Critical Quality Attributes of Your Design Space
Michael Weiser, Ph.D., Project Manager, Technology Transfer, Octapharma Pharmazeutika
Today there is a move from Quality by Example to Quality by Design. But how do we select and determine quality criteria? This presentation will explain what the Critical Quality Attributes (CQA) are, and explore what impact they have on Quality by Design. This talk will outline at what stage in development CQA should be determined, and give case studies how to select CQA.
2:35 Paradigm Shift in Biopharmaceutical Manufacturing – 1985 → 2010: A Status Report
Wolfgang Noe, Ph.D., Vice President, Bioprocess Development, Biogen Idec
Case Study
3:05 Development and Implementation of a PAT Application for Monitoring Protein Refolding at Production Scale
Shelly A. Pizarro, Ph.D., Scientist, Process Research and Development, Genentech, Inc.
One of the goals of the US FDA Process Analytical Technology (PAT) initiative is to “actively manage process variability using a knowledge-based approach.” This case study presents the development of a continuous monitoring system for a protein refolding reaction that is highly dependent on oxygen. Laboratory scale development in 3-L bioreactors using sensors for % dissolved oxygen and redox resulted in a PAT application that provided consistency in product quality and process performance across batches. Implementation at production scale demonstrates the method robustness at multiple scales.
3:35 Poster Highlight:
Overview of the Technology Innovation Program at NIST
Mrunal S. Chapekar, Ph.D., Senior Biochemist/Project Manager, Project Management Office, Technology Innovation Program, National Institute of Standards and Technology (NIST)
On August 9, 2007, the President signed the America COMPETES Act which created the Technology Innovation Program (TIP). The mission of TIP is to support, promote, and accelerate innovation in the United States through high-risk, high-reward research in areas of critical national need. This presentation will familiarize participants with the key elements of the program and highlight any new developments related to TIP funding opportunities. The presentation will discuss the TIP draft Healthcare White Paper, prepared by TIP based on input from the technical community and other public information. This white paper is available on the TIP website for public comments. In addition, the TIP call for external white papers to provide input to TIP on critical national need topic areas for future competitions is also available on the TIP website.
3:55 Networking Refreshment Break, Poster and Exhibit Viewing
4:30 Analytical Methodologies to Simplify In Process Product Quality Assessment
Dell Farnan, Ph.D., Group Leader, Protein Analytical Chemistry, Genentech, Inc.
Samples from in-process pools often require additional sample preparation steps before they can be evaluated using popular methods for size and charge heterogeneity. These sample steps can potentially introduce a bias to the results; therefore the suitability for use needs to be ensured. Sample to Result approaches that minimize the number of steps involved, minimizing labor and risk will be discussed.
5:00 Use of Transgenic Systems for the Production of Antibody-Related Products
Julio Baez, Ph.D., VP, Biologics, Richmond Chemical Corporation
Recently a transgenic animal milk-derived biopharmaceutical was approved while several transgenic plant-derived products are advancing in clinical trials. We had also seen the use of alternative production systems to mammalian cell culture to meet the cost, quality, and production demand of antibody-related products. The introduction of alternative production technologies for biopharmaceuticals is coupled with advances in analytics allowing the study of microheterogeneity associated with the production system. In this talk, we will explore how transgenic animals and plants can provide enabling technology and diverse antibody-related products with improved quality as compared with current systems while providing practically unlimited product supplies at a low cost. We will also discuss the development of the first monoclonal antibody derived for a transgenic system (corn seed).
5:30 Small Group Break-Out Discussions
We present these one-hour moderated discussion groups to allow researchers the opportunity to network and exchange information with colleagues from around the world in a small-group setting. Each table will address a scientific topic that is related to the meeting to enhance in-depth discussion and interactive problem solving with the potential for establishing collaborations. You will select a topic group, sit down at the selected table, and join the discussion.
Table 1: Drug Development Process Governed by Acronyms?
Moderator: Kim Wong, Ph.D., Director, Facilities & cGMP Support, Process Development, sanofi pasteur
The landscape for the development of drug candidates along the pipeline towards licensure is evolving and becoming more complex. Companies need to take into consideration new regulatory agency and industry initiatives often denoted by acronyms such as GXPs, QbD, DOE, PAT, REMS , CPPs, CQAs, and RTFT. At the same time organizations need to address increasing business pressures to perform our tasks better, faster and cheaper (BFC). How organizations deal with these apparently competing factors will the subject of discussion.
- the objective for biopharmaceutical organizations is to produce safe and high quality materials for either clinical trials during the development stages or for product sales post-licensure
regulatory agency expectations for biopharmaceutical process development include the incorporation of elements such as GXPs, QbD, DOE, PAT, REMS, CPPs, and CQAs
- what do each of these acronyms mean?
- how do these elements impact on the cost and time demands of the drug development process?
Table 2: The Steps Needed to Achieve Lean Manufacturing for Biologics
Moderator: Julio Baez, Ph.D., VP, Biologics, Richmond Chemical Corporation
Table 3: Developing and Maintaining Continuous Improvements
Moderator: Dell Farnan, Ph.D., Group Leader, Protein Analytical Chemistry, Genentech, Inc.
Table 4: The Real World of PAT (Process Analytical Technology) – Hurdles versus The Rewards
Moderator: Dagmar Meissner, Owner & Founder, BioProcess Solutions
Table 5: Dealing with Regulatory Authorities & Inspections
Moderator: To be Announced
|
6:30 Networking Reception in the Exhibit Hall
7:30 End of Day One