Sterilizing Grade Membranes ASTM F838-05 and What You Need to Know!

I have been working in filtration for many years here in the Bay Area and many times the simple question comes up - what is a sterilizing grade filter?  Why do I need 0.2 um vs 0.45 um?  Why is one filter called a "Biorburden" reduction filter and the other certified as "Sterilizing Grade".  As I am actively working on projects where these same discussions are raised I wanted to share an article I recently discovered that gives the history of sterilizing grade membranes, the regulatory standards that developed, and offers great insight on the topic.  A sterilizing grade filter needs to meet ASTM 838-05 - boiled down to the simplest of definitions this means that the filter needs to meet a very specific bacterial challenge test where the filter removes 1 x 10^7 CFU/cm2 of membrane using a very specific organism B. Diminuta.  I also previously worked with one of the authors Maik Jornitz who is an expert on process filtration and has published many books and articles on the topic.  Here is a link to the article and I hope you find a wealth of information there:

http://www.pharmtech.com/assuring-sterility-astm-f-838-83

As always I am available to help with filtration training or discuss regulatory guidance with respect to filtration as it is an industry topic I really enjoy working with.  Feel free to contact me anytime if you need help with Filtration!

Watersep Offers Complete Single Use Hollow Fiber Assembly

Watersep has recently expanded their capabilities to include complete single use assemblies integrated with their Hollow Fiber device.  We can offer single use assemblies from small scale to large scale integrating single use pump heads, pressure transducers, and flow rate sensors into the complete assembly as well as single use bags for liquid handling.  This is an excellent solution for single use cell separation on a bioreactor for perfusion processes or great for single use UF/DF.  Watersep offers extremely cost competitive solutions for single use assemblies vs. flat sheet cassettes, as there are significant economies of scale with respect to the manufacturing costs associated with hollow fiber production.  Whether you are looking to separate cells or concentrate proteins this is a great fully single use alternative!

Watersep Single Use Hollow Fiber Assembly

Finesse and C Cubed to Attend BPI West show San Francisco Next Week!

I will be attending the BPI West Show Feb 27-March 2nd this year representing Finesse Solutions - join us at booth 207 to see how we can help out with your process- looking forward to seeing everyone there!  Regards, Chris! 

https://lifesciences.knect365.com/bpi-west/

https://lifesciences.knect365.com/bpi-west/sponsors/finesse

Lowering the Cost of Single Use in the Future

Lets face it when single use bags and filtration started to hit the Biotech market the technology and concepts were revolutionary.  The market initially rejected the idea that high value product could be contained within a single use bag and that stainless steel was the way to go as it was the status quo.  Now we see a rapid adoption in the market place and boy have things changed!  In fact I sometimes would actually recommend the old cartridge style of filters at 30% less for applications like buffer filtration or less critical filtration applications only to be told "No we only want single use filters!!" - it was funny as I always try to offer the best solution at the best price point but in this case the customer wanted to spend 30% more to go with current trends when it really wasn't necessary.   It was an interesting revelation realizing the massive change in perception toward single use processing.  As Biosimilars rapidly enter the market place threatening to signifcantly decrease the market share of commercial Biotech products, we are seeing more and more companies looking into the cost pressures they are under, looking for ways to cut costs and suddenly realizing that their annual spend on single use bags and filters are adding up to staggering levels - sometimes way beyond their initial projections.  In fact a colleague of mine told me an interesting story where one company after evaluating the amount of money they spent on single use bottle assemblies went into full reversal and switched back to reusable glass bottles.  Imagine what a company can do if they are able to cut their single use consumables spend in HALF!  Funds can immediately be reallocated to additional investments for the lab, additional personnel or even better - the company greatly increases its profitability and extends it's cash flow - for a small start up or mid range biotech looking to gain more time to develop through to phase II or phase III clinical trials this could be the difference between closing the doors too early or extending the life of the company to have the time to develop innovative new therapies.   As we see manufacturing companies developing single use filtration and single use bags at lower labor costs, and offering the market place better solutions with cost competitive price structure there is a huge focus that I have noticed over the last few years on lower cost solutions.  While there are many value based approaches that companies offer, with often false claims of value grandeur, many can not offer a 50% reduction in consumables spend based on price, it goes against the massive margins they need to achieve, to increase their profitability and would disrupt the current price structure of single use products in Biotech that many of the top players currently enjoy.  I expect the price structure of single use filtration and bags to become more of a commodity in the future and I am already working with companies who are addressing the need of the marketplace to reduce the spend of single use, offering excellent high performing products at significantly lower cost.  I think companies that focus on lowering consumable spend and aligning themselves with lower cost players will have a competitive edge in the future, and will not need to make costly changes as their processes mature toward commercialization.  By partnering with manufacturing companies who are ahead of the curve with lower production costs, and the lowest pricing available on the market companies can continue to enjoy the benefits of single use in the future, remain competitive in their market segment, and significantly extend their cash position.

C Cubed and Finesse will Attend BPI West Show February 27 - March 2, 2017 Hilton San Francisco Union Square, San Francisco, CA

I find the BPI shows are very informative and most importantly well attended which gives everyone in the Biotech community a chance to share ideas, potentially catch up, and hear about new technologies.  Here is a link to the show https://lifesciences.knect365.com/bpi-west/.  Speaking of new technologies Finesse has recently expanded their capabilities for their process control to offer complete SMART Factories covering both upstream and downstream processes - from the seeding of the first cells to the vial - Finesse can offer a complete single use factory and the best part is the process actually reflects a real process.  The reality is every customer chooses the best process equipment for their needs so naturally throughout the process you may see many different manufacturer's process equipment for each process step.  The beauty of the Finesse control system is that it can adapt to any manufacturers process equipment - that's right you don't need to be locked in to a single manufacturer for single use bioreactors or for UF/DF, Column Chromatography etc.  What does this mean to manufacturing?  It means flexibility and most importantly from a business stand point the ability to negotiate on single use - you are no longer locked into GE only or Sartorius only or Thermo Fisher bags only - this means you can switch bag suppliers, or qualify multiple suppliers and work with the partners you are happy with!  That is one of the huge advantages that Finesse offers.  If you are visiting BPI West stop by and say hello!

C Cubed Biotech to Represent MDI Filtration

I am pleased to announce that C Cubed Biotech is now representing MDI filtration in the Bay Area.  MDI is an innovative filtration company who has been developing and manufacturing their own membranes since 1978.  They have a wide range of filtration products for the laboratory and process scale.  So far we have had excellent feedback from clients who have initiated testing of their filtration products.  They offer a customer focused approach, local stocking in the United States for increased security of supply, and have been successful at helping bay area companies to substantially lower their filtration costs.  Please feel free to contact me to learn more!

Finesse is Launching their 3 L Single Use Vessel and it is Awesome

SANTA CLARA, Calif., Oct. 15, 2014 /PRNewswire/ -- Finesse Solutions, Inc, Santa Clara, CA, a manufacturer of measurement and control solutions for life sciences process applications, announced the launch of beta testing of SmartVessel™, a single-use 3 liter bioreactor vessel with integrated single-use sensors for cell culture applications of mammalian cells, stem cells, insect cells, and plant cells.

This stirred tank single-use bioreactor allows working volumes from 0.5L to 2.2L and is supplied as a completely preassembled and presterilized unit that is immediately ready to use. It eliminates the need for labor-intensive steps such as autoclaving or installation of probes, minimizing the time needed for process setup.

The SmartVessel leverages the same integrated SmartPuck sensor technology for pH, dissolved oxygen (DO) and temperature measurement as the SmartRocker. All wetted materials of the SmartVessel are USP class VI compliant. The SmartVessel also utilizes the same impeller configuration and agitator motor as the Finesse SmartGlass vessels and has been designed to provide almost identical performance in mixing, kLa, and thermal control, but with the efficiency and flexibility of single-use systems. It is both interchangeable with and comparable to in performance with the SmartGlass and readily interchangeable with the SmartRocker when used with the G3lab Universal Controller.

"SmartVessels represent the continued commitment of Finesse to bringing single-use solutions into the lab scale cell-culture market. Along with our SmartRocker and TruFluor pH/DO sensors, the SmartVessel will minimize end user labor in bioreactor cleaning and setup, and maintain fidelity of control. We anticipate that the SmartVessel will provide a unique, complete solution for process development and optimization, as well as production of seed cultures and cell banks," stated Finesse Chief Technology Officer and co-founder, Dr. Mark Selker.

Finesse Solutions Announces CellWorld 2015

Santa Clara, California (March 26, 2015) — Finesse Solutions announced CellWorld 2015, a new event that is specifically designed for innovators, visionaries and senior executives in bioprocessing.

The two day conference, by invitation only, will be held at the Hyatt Regency in Downtown San Francisco on September 21-22, 2015. It will be a forum for life science leaders to discuss the future of single-use biopharmaceutical manufacturing and to hear about both disruptive technologies and best practices from all facets of our industry.

The event sessions will cover both upstream and downstream single-use bioprocessing with a focus on innovation through the use of novel measurement and automation systems. It will introduce new tools for managing process complexity and the resulting intelligent meta-data. Topics will range from new single-use sensors to implementing commercial-off-the-shelf, highly configurable manufacturing execution systems (MES) for single-use facilities.

“Our goal is to provide the senior leadership in bioprocessing with a glimpse of the future in order to fully exploit single-use technologies and to remain globally competitive,” stated Barbara Paldus, CEO of Finesse Solutions. “We are very excited to create the first international forum to explore innovation and technology, so that as a community, we can accelerate the adoption of new bioprocessing platforms and fully exploit highly intelligent tools that are rapidly becoming available through advances in electronics, software, and communications.”

C Cubed Biotech to Represent G-CON Manufacturing

We are pleased to announce that C Cubed Biotech will be representing G-CON Manufacturing in Northern California.  G-CON Manufacturing Inc. designs, produces and installs prefabricated, autonomous cleanroom PODs. G-CON’s cleanroom POD portfolio encompasses a variety of different dimensions and purposes, from laboratory environments to personalized medicine and production process platforms.  G-CON is at the cutting edge of modular clean room design  as companies look into flexible facilities of the future.

Finesse Reports on Cell World 2014 Shanghai

After the forum, Dr. Barbara Paldus, CEO of Finesse Solutions, gave an interview to Bio Equipment. She noted that Asia accounts for 25% of Finesse global business and is growing rapidly in this region, especially in China. CellWorld Shanghai was organized to serve this large market and has become a routine event in China. It provides an excellent opportunity for Finesse Solutions to meet customers and introduce new products. Dr. Paldus anticipates that CellWorld 2015 will be launched globally including the USA and Europe. CellWorld Shanghai will return in October 2015 and expects to welcome more than 100 delegates.

http://www.prnewswire.com/news-releases/finesse-reports-on-cell-world-2014-shanghai-281887481.html