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.

3rd Annual Oligonucleotide-based Therapeutic Conference:
Where Regulators and Industry Partner to Advance Oligonucleotide Science Together

March 23-25, 2010
DoubleTree Hotel and Executive Meeting Center
Bethesda, MD, USA

Tracy TreDenick, Head of Quality and Regulatory for BioTechLogic, will be participating on the panel for session 5B: CMC Track. She will be discussing "Attributes of Success: Development through Commercialization" and taking part in the Q&A session, as well as availble to meet with interested parties all during the conference.

This conference will serve as a continuum for discussion among Industry and Health Authorities to inform, educate, and share oligonucleotide-based therapeutic product development and regulatory information in the areas of nonclinical, chemistry, manufacturing and control (CMC) and clinical development. These sessions will address targeted therapeutics and exploratory approaches of oligonucleotide-based therapeutic drugs, including bioinformatics, microRNAs, delivery, impurities and metabolism, hresholds and pre-clinical immune screenings prior to IND filing. Delivery technologies are of high priority to expand the therapeutic indications of oligonucleotide-based therapeutics and therefore this conference will also incorporate current dialogue to address RNA interference technologies and expand to the therapeutic segment to discuss emerging technologies for oligonucletoide science.

BioTechLogic will be participating in these upcoming events!

BioPartnering North America 24th - 26th January 2010 Westin Bayshore Resort Vancouver, BC, Canada	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.
Cell & Gene Therapy Forum North American Vaccine Forum 25th - 27th January 2010 The Grand Hyatt Washington DC
Biomanufacturing Summit North America 2010 26th - 27th January 2010 Hyatt Regency La Jolla Aventine, California

On 12 January 2010, FDA and industry representatives will come together at the CGMPs for Combination Products—An Interactive Analysis With Industry and FDA to discuss the proposed rule to codify current Good Manufacturing Practices for combination products.

The proposed rule will have significant implications for companies like yours that develop and commercialize these types of products. For that reason, your comments on this rule are critical.

Join Adeana Dorsey, Regulatory and Quality Systems Manager at Biotechlogic, as she sits down with decision makers and the FDA to review specific case studies associated with 21 CFR 4: GMPs for Combination Products.

This program is being offered as both a face-to-face meeting held in Rockville, MD and a live Webcast you can access from the convenience of your home or office.

Register for the face-to-face program by 5 January and save!

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.

For a second year, Tracy TreDenick, Head of Quality and Regulatory, and Patrick Giljum, Head of Operations, at BioTechLogic, Inc. have been asked to guest speak during the Drugs and Biologics Regulations course for students pursuing their Master’s of Science in Quality Assurance and Regulatory Science through The School of Continuing Studies (SCS) at Northwestern University on Tuesday, October 27th. This class discusses current policies and guidelines under which pharmaceutical and biological products are developed for human use and regulated while in commerce. Topics include regulatory requirements for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. Students also examine the newly implemented steps to harmonize international regulations.

We would like an opportunity to share our project experience and hear about your potential project needs. Give us a call and let's set up a meeting. Even if you just want to say hello to the BioTechLogic team, make sure to reach out and let us know you are there. See you then!

BioTechLogic is hosting a reception for this event.

Tuesday Oct. 13th, 2009 7:00PM
The Oxford
319 Fayetteville St # 105
Raleigh, NC 27601-1978
Get Directions
www.oxfordraleigh.com