The Big Red Biotech Blog

Pfenex and MedImmune partner on early stage proteins and vaccines

Pfenex and MedImmune will partner up in a three year pact to use Pfenex Expression Technology to develop bioprocesses for MedImmune human therapeutic proteins and vaccines.

Pfenex expression technology to engineer production strains for MedImmune's proteins and vaccines.

Pfenex will engineer production strains, using its Pseudomonas fluorescens organism, broad tool box, and high throughput robotically enabled strain screening platform, to express MedImmune lead molecules. Pfenex claims that it routinely can go from DNA to an identified production strain within 8 weeks.  MedImmune will carry forward preclinical and clinical development. 

MedImmune senior vice president of biopharmaceutical development, Gail Wasserman said "Pfenex's scientific approach to strain development and protein expression is robust and aligned with the way  we work at MedImmune."

The Pfenex system utilizes defined development and production media that are free of animal proteins. The platform has been accepted by US and international regulatory agencies in multiple human clinical trials up to Phase III currently in progress.

 

Posted by Bruce Lehr May 12th 2011.

CHO K1 Sequence Helps Cell Engineering Efforts at SAFC

With the report today that BGI and GT Life Sciences have sequenced CHO K1 and will soon make that sequence available, I'm excited to see the data used in our cell engineering efforts.  SAFC has licensed rights to zinc finger nuclease (ZFN) technology from Sangamo for use, among other things, in the engineering of CHO cells for bioproduction.

in fact, this past month SAFC introduced new ZFNs for the dhfr and GS genes to allow users to create CHO bioproduction cell lines under license. Soon, catalog versions of CHO cells with these genes knocked out will also be available for purchase and again under license for use in bioproduction. Our ultimate goal is to produce a SuperCHOZn platform cell line, media, feeds, protocols and application data to allow a user seeking a platform production system to buy one.  The SuperCHOZn line would be expected to have multiple knock outs and/or knock ins to confer important production properties of interest on the cells -- and would be sold with chemically-defined medium and feed sets to support their growth and productivity to high levels with desired protein quality characteristics.

To this end, it is welcomed to have the CHO genome sequence for K1 available.  It will aid our work in target discovery and ZFN design to find, validate and knock out targets to make cells more productive, better growers, more consistent protein producers with appropriate quality and lower variabilty.  We can also eventually make more efficacious molecules -- i.e. manipulating glycosylation patterns or even do a more efficient job of matching glycosylation or protein quality characteristics to aid the biosimilar market as it develops.

So, I tip my cap to Bernard and collaborators at BGI and GT Life Sciences and look forward to delivering more improvements - faster - within CHO cell line bioproduction systems.

 

Posted by Bruce Lehr Jan 6th 2011.

 

GEN Webinar: Impact High Titer Processes on Protein Quality

Over the past decade it has been all about titer, titer, titer in the biopharm industry as process development groups strove to reach "holy grail-type" production levels of 10 g/L or more (at least for MaBs). 

Now, many groups in the industry have reached that level or even exceeded 10 g/L and have concluded that may be too much. There seems to be a consensus building in the industry that 5 g/L is fine from a COGs perspective and that gains above 5 g/L don't save that much in additional COGs and create more problems with protein quality.

 

GEN will present an educational webinar on September 27th and 28th entitled, "Impact of High Titer Process on Product Quality".  Registration for the webinar is FREE.

Topics covered will include the following:

• Comparing cell-line productivity using a traditional fed-batch system versus high-density cell culture to express Fc-fusion proteins or antibodies
• Impact on aggregation, glycosylation, and in vitro activity resulting from high-density cell culture processes
• Increasing titer output without changing the genetic construct or process media
• Downsizing bioreactors while maintaining high yields of a biopharmaceutical product
• Reducing cost of goods and time to market 

The event will be moderated by GEN Editor in Chief, John Sterling.  Industry Panelists include: David Bienvenue, Assoc. Dir., VLST Corp., Wei-Kuang Chi, VP and Director, cGMP Biopharmaceutical Plant, Development Center for Biotechnology, Rolf Douwenga, VP, Global R&D, DSM Biologics

Posted by Bruce Lehr September 21st 2010.

SSB/SAFCB: Want some application data with that?

In July (Bastille Day by happenstance), Sartorius Stedim Biotechnology and SAFC Biosciences announced its partnership to bring our product offerings together with the intention of better serving our joint customers in the biopharmaceutical development and production space. 

 

Since our products are amazingly complementary in their use, we feel that by working together we can better jointly address application issues that involve interaction of our products (e.g. cell culture media & sterile filtration) more effectively.  In fact, we are working together to look at medium/filtration issues in several accounts.  Working together is beneficial for us, and ultimately for the customer. It makes communication and collaboration easier for everyone and allows expertise from differing areas to be supportive of one another.

 

When our release came out, we talked about working together in areas of filtration, mixing and in liquid handling.  We’ve now been working behind scenes long enough that all of these projects are underway.  The idea is to generate real application data with media and buffers combined with single use disposables, mixing systems and filtration systems. 

 

Here’s what’s going on.  We essentially have three major study programs: Mixing, Filtrations and Storage in Single Use Disposables. In all instances, we are looking at popular, industry relevant products for cell culture (e.g. media/feeds) and downstream processing (e.g. buffers), and determining how they can be optimally used with various mixers, filters and single-use bags.  Let me elucidate a bit. 

 

Mixing

We’ll do a matrix study using powdered media & buffers and several types of mixers.  We’ll look at different mixing volumes reflecting different scales in a production process.  The media and buffers involved in the study will not only be ones commonly used in the industry, but will contain components that are “easy to mix” or “very difficult to mix” from a historic perspective. At the end, we’ll be able to advise confidently on which mixing/product applications are best at differing scales and will be able to give information on best operating parameters.  The QC data will also be available to review.

 

Filtration

We’ll do a very similar study with filters.  Again, we’ll test industry popular media, feeds and buffers.  These will contain components that are known to give more ‘trouble” in filtration or not.  We can look at several different types of filters – different membranes, sizes, and differing scales reflective of different unit operations within a process. This will again allow us to make recommendations about appropriate filter trains and cost/benefit statements relative to certain configurations.

Single Use Disposables

Again, a very similar matrix study is underway.  Here we’re examining various media/buffer configurations with single use disposable bags.  We’ll be generating leachable and extractable information.  We’re also developing stability information on these products.  We can do this with multiple film types and at different scale.

 

We think this type of application data packets allow us to speak more expertly about our joint product offering. We can do this as we both have expertise in different areas and it makes it much easier to do these type of studies as cooperating partners rather than each of us having to go it alone.  We expect to learn new things along the way that we can incorporate into our thinking going forward and share with our customers. 

It is about knowing our product better and supporting our customers better. We believe that our customers will find this valuable.  However, I’d really like to hear your opinions.  They’re worth more than mine.  

Posted by Bruce Lehr February 2, 2010.

 

Cool CMO Site

I came across this cool site called CMO Locator by Kymanox.  It allows you to find CMOs among its registrants who have the capabilities that you are looking for to execute your project.  For example you might designate a need for a CMO that can meet following needs -  mfg drug substance API, platform cell culture, scale 2000-5000 L, fed-batch process, phase I/II compliance, biosafety level 3. 

The tool will spit out a list of CMOs matching those criteria.

Posted by Bruce Lehr January 31, 2010