BioTechLogic News

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 March 14 - 18, 2011 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
Validation Week Europe March 28 - 30, 2011 Marriott Amsterdam Amsterdam, Netherlands	TIDES May 22 - 25, 2011 Hynes Convention Center Boston, MD

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.

Background:

1. The FDA’s Draft Guidance on Process Validation is nearing approval stage.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.
2. 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:

1. The concepts contained in the draft guidance document are not revolutionary.  In many ways, they reinforce what we (BioTechLogic) are already doing.
2. 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.
3. 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):

1. 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.
2. 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):

1. 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.
2. 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):

1. There is a strong emphasis on Statistical Process Control (SPC) for this stage.
2. Whereas commercial data evaluation in the form of an annual report was previously expected, more frequent monitoring and formal internal reporting will be expected.
3. 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.
4. The agency strongly recommends a formal protocol for CPV.

Julie Trajkoski, Senior Manager, Operations for BioTechLogic, Inc. has been invited to participate on the 2010/2011 BIO International Convention Program Committee. The 2010 BIO International convention will be held in Chicago’s McCormick Place Convention Center on May 3-6, 2010.

The world’s premiere biotechnology event, and the industry’s largest and most diverse meeting was held this year in Atlanta, GA, attracted 14,352 attendees from over 60 nations. The exhibition at 2009 BIO featured more than 1,800 companies, organizations, and institutions representing every aspect of the biotechnology industry.

The task of the Program Committee is to help create a top-quality educational convention program by providing expert recommendations to the BIO. There are approximately 17 tracks to be reviewed and the committee members will be tasked to identify the most qualified submissions received. Membership will be made up of local, regional, national, and international biotechnology professionals and members are invited to serve for 2 years to add more continuity to this important role.

Are you heading to BioPharm America? Partnering has opened and we want to hear from you. BioTechLogic, Inc. is a technology and manufacturing management firm that helps clients bring biopharmaceutical products to market quickly and successfully-by augmenting and optimizing an organization's technical resources. We understand the difficulties of the drug development process and that even successful biopharma companies are constantly troubleshooting potential roadblocks or are in need of extra manpower to meet timelines or milestones. We can do this and much more. As a proven biopharmaceutical consulting/hands-on resource firm, our expert staff of CMC, Manufacturing, Technology, Analytical, QA [Process and Facility PAI Readiness] and Project Management professionals has helped both oligonucleotide and protein products gain worldwide regulatory approvals.

We'll be taking meetings all through show hours but if you can't meet us then or think you will need some dedicated time just give us a call and we'll set up a meeting. Even if you just want to say hello to the BTL team, make sure to reach out and let us know you are there. See you then!
http://www.biotechlogic.com

Contact:
Nathan Carris
Business Development and Marketing, Manager
Phone: 773.687.9314
Email: ncarris@biotechlogic.com

Peter Dellva
Head of Business and Finance
Phone: 847.730.3475
Email: pdellva@biotechlogic.com

BioTechLogic announces the appointment of Nathan Carris to the position of Business Development and Marketing, Manager, reporting to Tracy TreDenick, Head of Quality and Regulatory.

Nathan has nearly five years of experience in the biopharmaceutical industry with the Illinois Biotechnology Industry Organization (iBIO), serving in capacities that support network building, client services, government relations, business development and marketing. His knowledge of the biotechnology industry and his ability to forge strong relationships with individuals and companies adds additional value to BioTechLogic and its clients.

As Director of Communications at iBIO, his responsibilities included point of contact for client needs, event management with on-site customer service, development and maintenance of online and print materials, PR and media supervision, coordination of lobbying efforts, as well as troubleshooting organizations' needs and executing on other day-to-day operational activities.

He holds a B.A. in Communications from Purdue University.

BioTechLogic is a biopharmaceutical management firm with a unique, proven ability to rapidly bring products to market through the augmentation and optimization of a corporation's technical resources.
Our team of professionals have expertise in process development, project management, manufacturing, equipment qualification, process validation, cleaning validation, analytics, supply chain management, quality systems, regulatory submissions and pre-approval inspection (PAI) readiness.
As workloads exceed resource capacity due to accelerated commercialization timelines and/or when objective third party input is required to solve problems or develop strategies, BioTechLogic can provide technically skilled personnel to fill the needs.

Please contract Tracy TreDenick at 630.260.1981 or Peter Dellva at 847.730.3475

http://www.biotechlogic.com

BioTechLogic will be exhibiting at IBC's 13th International Process Validation for BioPharmaceuticals Conference & Exhibition 2009 in La Costa, California.  The conference, which runs from March 2-3, is co-located with the Outsourcing Manufacturing of Biopharmaceuticals and the Technology Transfer for Biopharmaceuticals conferences.

Exhibiting at the Process Validation conference will provide additional opportunities for continued growth in BioTechLogic's technical offerings.  "We look forward to the opportunity to showcase our capabilities to a wider audience with bioprocessing needs." - Peter Dellva, Head of Business and Finance.