Here is a Google Earth tour of the RXIV area. Please down load Google Earth first, then double click on the tour file.RXIV Tour Google Earth Files
Download the ZIP file, extract the files, and open them up in Google Earth. Double click on the _RXIV Tour Final file last for the tour.
This tour will be played Sunday night, so if you get here first, you can brag to your friends at the dinner table. Also, you can stop me sometime during the evening and let me know what you thought.
Jon
Please find below several ways of downloading the schedule at a glance.
First, a link to a Google Calendar. You can also link to it if you have a Google account yourself by linking to RXIV.email
Secondly, you can download these Outlook compatible appointments. They should also work with many other email/calendar systems. We could not get these to work with the iPhone, though. Let us know if you do. When you open the Zip file, you will have to individually double click on each appointment to open and accept the appointment into Outlook.
Finally, you might find handy a small PDF version that should be compatible with most mobile devices. SmartPhoneSchedule
Hope you find one of these useful. Let us know through the comment link below which works for you.
We are just wrapping up the last bit of programming for RIXV. We are SO excited to get there and see all of you. Our theme, “Making Connections,” is integral to our program. We hope to make many connections with you as the program progresses.
This blog will be open during the conference, and people can comment on the talks. We will also have updates on the program as we progress. I will be pointing out web links that will help us make connections during and after the conference. For instance, this blog can be easily reached by using bit.ly/RXIV_Blog
Use RSS to keep track of blog entries: copy this into your RSS reader http://bit.ly/RXIV_Blog1
RSS for blog comments: copy this into your RSS reader: http://bit.ly/RXIV_Blog2
The blog will be the primary means of communicating last minute information to you.
Please consider joining LinkedIn and joining the Recovery of Biological Products 2010 group. Only those who are attending the Recovery conference will be members. This group will allow us to contact each other long after most of us have changed email addresses (if we update our linked in).
We have created a page on Photobucket to share photos. Please look in your program for the web address and password information.
Photobucket is a website that allows a closed group of individuals to share photos with one another. We will use this site to gather photos from your networking activities. You can also comment on one another’s photos. Identifying the participants of various networking activities will also be helpful for those of us with poor memories! Please help us make connections by uploading photos of our networking activities. No photos of posters or presentations will be allowed without the author’s consent.
This photo site will remain closed, and we would appreciate not sharing the site name and password with others. We will monitor the site daily and remove photos that may reflect badly on our members, our sponsors, or the Recovery Conference series.
We have created a Facebook page. The web address is http://bit.ly/RXIV_FB I’m not sure how useful this will be, but it may be better than Linked In. If you have a FB account, please link into this one. I’m (Jon) the owner of the account. The user name is Jon Rxiv Coffman, since facebook does not allow organizations to own an account. [Note as of 23July10] There are over 65 people now connected on the Linked In group, and only about 5 on the Facebook.
If you are seeing this post then you are on the new server and the move is finished (though you may end up at the previous location a few times yet.) Thank you for your patience.
This is a policy change from the February launch of the blog, and all authors of comments or entries have been informed and their entries deleted if they preferred not to publish (or if they didn’t get back to us). The RXIV chairs decided that opening the blog to all comments would improve the level of programming and feedback in the blog. Most of the entries over the past 9 months are now readable by anyone. We will be populating the blog with the call for papers for each session. We hope you comment on ones you have an interest in. We expect that everyone will show gracious professionalism. We hope that when you comment, you will use your real name. This policy will not be enforced. First time commentators will require review by the moderator prior to posting; future comments will post automatically. Unprofessional comments will be deleted. The commentator may be blocked from future comments (we don’t expect this to happen much).
We encourage a good debate. Enjoy!
Brendan Fish and Jurgen Hubbuch
This decade has seen the maturing of processes for the manufacture of Mabs mature into a platform technology. The advantages for speed of candidate transition from discovery to full process are self-evident and with careful engineering cost-effective process solutions may be realised. These platforms rely heavily on established technologies and the room for innovation might be felt to be somewhat constricted. Furthermore as QbD principles become more firmly entrenched as the norm for routine operation and practice it could be argued that the incentives to create radically new designs are reduced. The status quo is favoured. Finally, if we look at the lessons from history, are we really confident that radical breakthrough technologies are poised to emerge into the arena? The very conservatism of the industry tends to stifle such innovation.
So what then is the future for downstream process development? Is there a future or will the next decade merely involve a series of iterations and incremental improvements in platforms? How can radical new approaches be adopted against a backdrop of regulation and a drive for confidence and robustness? Should we focus on how better to reduce the cost burden of quality systems currently needed to oversee manufacture? Ultimately many of us pride ourselves in the elegance of the technologies we pioneer and implement. Will we still be the expert practitioners and visionaries in a decades time or will the DSP development teams RIP?
All contributions welcome to the “wake” or “re-birth” of downstream process technology development and to what promises to be a lively debate!
(note: this entry was modified from the original. The text is from the final call for papers–Jon, Oct 3, 2009)
Glen Bolton and Abhinav A. Shukla
This session deals with the inter-relationships between the downstream process that produces pools of purified, highly concentrated, drug substance and the final formulation that maintains the drug product in a stable state for end use. Lessons learned from stability studies and excipient screening for the final formulation can be applied back to downstream process development. In a similar fashion conditions during the downstream process can influence a biomolecule’s behavior in the drug product formulation. Non-idealities in the final ultrafiltration/diafiltration (UF/DF) process step, such as incomplete exchange of buffer components, can influence the stability profile for the product. To date both experimental techniques and biomolecular modeling have been used to study the stability, efficacy, and bioavailability profile for products and develop improved formulations.
In this session we are looking for a range of presentations including:
* Case studies dealing with the topics noted above.
* Presentations that describe the development process for the final formulation starting from clinical entry, where the drug product is often frozen or lyophilized to commercial stages, where the drug product is often a liquid.
* Platform approaches to formulation development and the extent of integration with drug substance process development activities.
(note: this entry was modified from the original. The text is from the final call for papers–Jon, Oct 3, 2009)
Successful development of a manufacturing process is a balance between process and product knowledge and the time and money spent on any given product. More process knowledge may correlate with decreased costs required to support manufacturing due to less time and effort spent on investigations and process changes. Typically the more we spend on a given product, the less we have available for other products, thus decreasing the overall probability of success of the portfolio. Standards are also changing and we are encouraged to provide a more thorough characterization of our processes.
We must develop strategies to optimize the success of the R&D portfolio and push more candidates through the pipeline without sacrificing quality. With this background, how do we define the appropriate effort to to dedicate to any 1 process? Should detailed process characterization be part of the orignal license application or supplied after approval? Should we treat all products alike or should we devote more effort to products with proven mechanisms of action? Are there implications to successful development of biosimilars?
There are different goals and limitations in the development of formulations and the development of processes to deliver drugs in these formulations. How should the interface between the development of a formulation and the development of the process to ultrafilter a drug into a formulation buffer be managed? Are the two developed simultaneously or sequentially? Are different people and/or skill sets required for the two? Does this change for unique and challenging molecules as compared to platform antibodies? Is there an impact of DS formulation or processing on drug characteristics like stability, pharmacokinetics, efficacy, safety, product variants etc?
Paradigm shift for manufacturing facilities!?
In the past most manufacturing plants have been designed and constructed for a single product. In the light of high titer Mab processes multiproduct facilities will become increasingly common when moving from clinical trials to commercial production. The existing single product facilities may need to be adopted to allow the production of new products in the same facility. The following questions might help to get a better understanding.
What are major considerations to developing products to go into multiproduct facilities? What has to be considered while designing multiproduct facilities?
Can we change from one product to another within 2 weeks down time? What about 2 days downtime?
What are the bottle necks for fitting up to six prodcuts per year in one facility? (What are the technical, equipment, or quality systems bottlenecks and which of these dominate?)
How can we develop processes to enable facile product changeover within days?
Is there existing equipment that facilitates changeover? Does equipment need to be developed?
Does a multiproduct facility really need disposables, or is stainless easy to change over as well?