Technology and Manufacturing Solutions
for the Biopharmaceutical Industry
BioTechLogic, Inc. is a biopharmaceutical manufacturing and CMC consulting firm with strategic and practical/hands-on experience that helps clients bring their products to market quickly and successfully by augmenting and optimizing an organization's technical, manufacturing, analytical, and regulatory resources.
We are a team of professionals with expertise in process development, BioAnalytical services, process validation, project management, quality assurance, regulatory submissions and Pre-Approval Inspection (PAI) readiness. Our quality by design (QbD) approach enables us to effectively provide product development support, including: development reports, design of experiments, technology implementation, critical process parameter evaluation, technology transfer and scale-up, and on-site third party contract manufacturing support.
Latest BioTechLogic News
Meet BioTechLogic at These Great Events! - 2/25/2011
BioTechLogic will be participating in these upcoming events!
If you or your colleagues will be attending any of these events, contact us now to set up a time to meet and discuss how we assist companies with issues they encounter during the manufacturing and submission of their products.
Biopharmaceutical Development & Production Week Hyatt Regency Hotel Bellevue, WA | 2011 PDA/FDA Process Validation Guidance Workshop April 13-14 JW Marriott San Antonio Hill Country Resort & Spa San Antonio, TX |
Amsterdam, Netherlands |
May 22 - 25, 2011 Hynes Convention Center
|
BioTechLogic Invited to Speak on Panel - 2/24/2011
2011 PDA/FDA Process Validation Guidance Workshop: Aoril 13-14, 2011 JW Marriott San Antonio Hill Country Resort & Spa San Antonio, TX, USA
Kurtis Epp, Senior Manager, Manufacturing for BioTechLogic, will be presenting during Session P4 - Stage 3 Continuous Process Verification Implementation. The title of his presentation is "Post Approval Process Validation Reporting." He will be available to meet with interested parties during the conference.
The mission of PDA is to advance pharmaceutical and biopharmaceutical technology internationally by promoting scientifically sound and practical technical information and education for industry and regulatory agencies.
Brief from the PDA Workshop on FDA's New Guidance on Process Validation "The Shifting Paradigm in Process Validation" October 26-27, 2009 - 10/31/2009
Background:
- The FDA’s Draft Guidance on Process Validation is nearing approval stage. It has been circulating within the industry for comments for a year and FDA is committed to finalizing by the end of 2009.
- This was the fourth of five workshops to discuss the new guidance document and to solicit feedback from the industry. Consequently, the focus of discussions at the PDA workshops has shifted over the course of the year from review to implementation.
Introduction:
- The concepts contained in the draft guidance document are not revolutionary. In many ways, they reinforce what we (BioTechLogic) are already doing.
- What we sense as different is a renewed focus on Stage 1 (Process Design) and Stage 3 (Continued Process Verification) during PAI and CMC review.
- While we already knew this, “Process Validation” is now being considered as a progressive sequence of activities rather than as an event. Three consecutive successful full-scale batches is now a minimalistic approach.
Stage 1 (Process Design):
- Design of Experiment (DOE) during process development is now a must. Single variable experiments that lack an evaluation of interacting parameters are not sufficient for gaining process knowledge and defining Critical Operating Parameters.
- Process Characterization Reports should include a full discussion of both “design space” and interacting parameters. Statistical evaluation of experimental data is crucial.
Stage 2 (Process Qualification):
- Overall, this stage is very much the same. The biggest change is that FDA is very hesitant to use the term “three consecutive batches” to describe Process Qualification (PQ). “As many as it takes to demonstrate process control” is the new mantra.
- Additional sampling throughout PQ was emphasized. It was also noted that additional sampling should continue after PQ and into Continued Process Verification (CPV) until the appropriate process knowledge is gained.
Stage 3 (Continued Process Verification):
- There is a strong emphasis on Statistical Process Control (SPC) for this stage.
- Whereas commercial data evaluation in the form of an annual report was previously expected, more frequent monitoring and formal internal reporting will be expected.
- Investigators are now being trained to inspect commercial sites one to two years post-approval to specifically evaluate: (1) maintenance of a validated process (i.e., CPV), (2) stability data, and (3) quality of incoming materials and components.
- The agency strongly recommends a formal protocol for CPV.
Presentations
Developing a Sound Process Validation Strategy - BioPharm Magazine December, 2007 - Article written by BioTechLogic's Dave Fetterolf.
Highlights of WCBP 2008 Meeting in Washington, D.C. - BioTechLogic's Mike Rooney attended this U.S. FDA co-sponsored meeting addressing analytical/regulatory for biotechnology products and prepared this summary.