MDI Harvester Cell Clarification Vacuum Filtration Device for Cell Harvest

MDI offers a very unique small scale filtration device to clarify cell harvest called “Harvester”. These are essentially Vaccuum Filtration devices with an integrated glass fiber prefilter which includes a coarse glass fiber layer and a micro glass fiber layer with a nominal pore size of around 0.7 um. This device can effectively eliminate the tedious task of cell harvest centrifugation and can rapidly speed up process flows such as clone screening for protein expression studies. MDI offers this technology in both 50 ml and 1000 ml format and this has been tested with high density CHO and HEK 293 cell lines. The product demonstrates MDI’s ability to engineer novel products for the biotech industry which meet a unique need for the lab. If you have a novel application or work in the lab and believe MDI may be able to assist with engineering a new solution please do not hesitate to contact the team at C Cubed Biotech - we enjoy developing novel solutions which solve unique probelms in the lab. The Harvester product is just one of many products developed from this approach to product development which is a the core competency of MDI.

A video below show the filtration product in action and the its efficacy with respect to cell clarfication directly from the bioreactor or shaker flask:

MDI Launches Novel UV Light Blocking Single Use Bag Film

MDI has recently launched a novel single use bag film which protects the media or drug product inside the bag from UV light. Many product formulations or medias are sensitive to degradation when exposed to UV light and this single use bag film is the first of its kind to provide a light blocking film which potects the product from potential UV damage.

The MDI AseptiFlex™-T Film is a highly inert, multilayered polyethylene film specially designed for bioprocess applications. The bag film has been tested for transmittance of UV light and shows almost complete blockage of both wavelengths of light. The table below shows the light transmission results:

This is a novel innovation from MDI and C Cubed Biotech is excited to present this to the Biotech community. The bag film can be scaled from small scale 100 ml sample bags to 2000 L production scale. We look forward to exploring the many applications where a light blocking film may improve the product quality and overall process for single use manufacturing applications.

C Cubed Biotech Partners With LSG to offer Custom Media and Reagents

I am pleased to announce C Cubed Biotech will represent Life Science Group in the Western United States. Life Science Group is one of the UK’s leading suppliers of quality custom biological and in vitro products. They have been a custom media supplier for over 30 years. They also offer contract manufacturing services and some interesting cell culture reagents they have developed in house. They offer an alternative to Trypsin for adherent cell lines as well as a custom reagent for shipping cells which does not require cold chain storage or dry ice for shipping.

LSG provides first-class service which is delivered by knowledgeable, approachable, flexible manufacturing teams. They offer full traceability on all products and GMP media production capability. I am pleased to partner with LSG and offer my clients an alternative option for media and reagents.

• LSG operate two Class 5 ISO 13408-7:2012 cleanrooms

• ISO 9001 and ISO 13485 accreditation

• Manufacturing using fully disposable, single-use systems

• Flexible packaging in bottles or single-use bags

• Custom labelling

• Batch sizes range from 10-1,000 litres

• All operations are carried out in their UK facilities

MDI Expands Single Use Technology Capabilities to Lower Lead Times to 8-10 Weeks for Delivery

MDI has made significant expansion to their Single Use portfolio offering a wide range of custom single use capabilities from single use bags from 50 ml- 2000 L with their new GMP qualified Aseptigold Bag film. Throughout the pandemic many suppliers have struggled due to long lead times, lack of expanded capacity and massive orders from large companies to try to secure 1 or 2 year supply. This has lead to the overall breakdown of the Biotech Industry supply chain and also revealed how a pandemic can uncover gaps in supply chain and capacity with some of the major suppliers. As the Biotech Industry rapidly shifts from stainless steel to custom single use technology for bioprocessing the accelerated demand in this area has revealed a need for new suppliers to provide additional capacity. MDI has plenty of clean room capacity and has undertaken some strategic initiatives to lower lead times for custom single use assembly to 8-10 weeks assuming subcomponents are available. MDI has leveraged their plastics injection molding capability to manufacture key components such as sanitary polypropylene fittings, reducers, quick disconnects and other key fittings that are critical to the single use assembly supply chain. They also have the unique advantage of being able to control their own filtration product supply chain which allows them to easily integrate any type of filtration components with a wide range of membranes PES, PVDF, PTFE just to name a few options. Given they have many components vertically integrated under their own manufacturing house this allows MDI to significantly reduce lead times and consistently maintain 8-10 week times during the pandemic. Given companies are far out with lead times anywhere from 25-52 weeks this is a massive advantage in the single use market place. They have also made significant investments in their single use quality programs and are actively involved in continuous improvement projects to improve quality. One example of this is they have recently completed extractables/leachables studies according to the BPOG guidance standards for both their bag film and filtration products. Considered by many experts in the industry as the most stringent and comprehensive testing protocol the BPOG standard has been adopted by many companies as the new industry standard for extractables/leachables testing in the Biotech industry. Many companies are now evaluating their single use capabilities and are surprised by the wide range of capabilities and high level of quality which is the reason their business is seeing substantial growth in 2022. They are an emerging supplier that should seriously be considered by new and established companies looking to diversify their supply chain and lower supply chain risk in the future.

C Cubed To Represent Advantapure on West Coast

I am proud to announce I will be representing Advantapure on the West Coast to provide high quality single use systems to the Biotech Industry. Advantapure is an innovative company focused on high purity single use products.

Their US manufacturing capability offers high quality custom single use assemblies that are qualified in many top pharma and biotech companies for GMP manufacturing.  Advantapure also manufacturers their own Silicone and TPE tubing with a wide range of options for process hoses as well.  Advantapure has the capability to offer overmolding technology which eliminates cable ties and ensures robust process connections.   They also have excellent in house engineering capabilities and a broad depth of knowledge with respect to single use assemblies to ensure they provide high quality products.

Advantapure is rapidly growing in the Single Use Market due to their excellent quality program and documentation, high quality custom single use assembly, high level of responsiveness and overall engineering expertise which many companies value as a single use partner

New HemiTor Single Use Pump!!

C Cubed Biotech is proud to introduce a revolutionary positive displacement fluid pump for critical applications in the Life Science industry. The HemiTor™ pump system is designed from the start as a replacement of conventional peristaltic pumps with inherent operation and performance limitations.
The HemiTor™ pump system has been granted several US patents for its innovative single-use, pulse-reduced, cassette for highly precise, repeatable dosing.

Function & Features

• Novel Single Use Design with diposable pump cassette that is easily integrated into single use assemblies

• Pump Operates Independent of Tubing ID/OD, pump mechanism acts on novel membrane cassette not the tubing itself, allowing for new tubing material types and greater ease of use

• Ability to perform Filling Applications to user defined target weight with Integrated Scale

• Advanced controller with fully programmable functions

• Controller features Ethernet, USB, Serial Port connectivity

• DC Servo motor provides highly reliable, accurate dispensing

• Capable of pumping low to mid viscosity fluids

• Push to connect fittings for easy assembly of tubing

• Faster change -over between projects & fluid types

• Pump operates from 1-1500 RPM at maximum 30 PSI

• Pump delivery volume range from 1 ml to 3 liters/min

C Cubed to Represent Malema Flow Sensors

I am very excited to announce that I will be working with Malema sensor technology. Malema is a Silicon Valley based company founded in 1981 who has recently launched a single use Coriolis flow meter called Sumoflow. The flow meter can operate independently of cell density, viscosity, air bubbles, conductivity and other parameters as it is based on coriolis mass flow measurement. The flow meter is extremely robust and accurate to within +/- 1% of the measurement and can be gamma irratiated into Single Use assemblies. I believe this sensor will have a wide range of applications and improve process measurement for single use processing

Introducing the MDI Aseptiprime High Throughput PES Sterilizing Grade Filter

MDI has designed a unique highly asymetric prefilter layer which provides substantially higher throughput for their PES Sterilizing grade 0.2 and 0.1 um membranes. This filter is their premier product, which they call Aseptiprime. The filter has performed exceptionally well with respect to cell culture media filtration and offers higher throughput vs some of the major filter suppliers at lower cost. The highly asymetric prefilter layer provides substantial protection of the downstream 0.2 um layer which results in very high throughput characteristics. I am excited to get out in the field and do more testing with this unique membrane and believe this filter can offer substantial benefits in the market place where higher throughput is required for more effective filtration processes. MDI has performed direct head to head testing vs the major filter suppliers and has performed filterability studies in order to measure the throughput advantages offered by this membrane and shown high throughputs reporting as much as 40% higher than other PES sterilizing grade membranes. For more information please contact me directly and I would be happy to provide data from the filterability trials.

MDI Launches Aseptivac New Vacuum Filtration unit with Expanded Filter Capacity

MDI has created an innovative new product called Aseptivac.  We all have used vacuum filtration units to quickly filter a liter of buffer in the lab - but what happens when you have a difficult to filter solution, or the media is plugging the filter?  Filtration capacity has always been a limitation with vacuum bottle filtration as they are using disc filters for most vaccum bottle filtration units - around 40 cm2 typically.  The engineers at MDI figured out a way to weld a 1 inch capsule into the bottle cap allowing for a 210 cm2 pleated capsule device to be integrated into the bottle.  This allows for greatly expanded capacity, higher flow rate and overall better performance with bottle filtration.  I have had customers use the Aseptivac product for cell harvest and difficult to filter medias and had very positive feedback regarding performance.  This is a great new product from MDI that shows their capability to find innovative solutions for filtration in the lab and manufacturing setting. 

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!