Biomanufacturing Innovations are Plentiful at This Year’s BPI Conference

December 17, 2015 • Written by Brandy Sargent

Every time I attend a big conference like BPI, one of my favorite things to do is wander the Exhibit Hall to see what companies are working on and what innovations are being developed to improve various aspects of biomanufacturing. This year’s BPI was no exception and featured many new and interesting products and services for biomanufacturing. I plan to cover as many as I can with this and upcoming blogs, but this is by no means an exhaustive representation. Please feel free to add additional innovations in the comments section.

Products and Services for Biomanufacturing

Apprentice Field Suite – Smart Glasses

One of my favorite stops this year during my BPI exhibit hall tour was at Apprentice Field Suite (AFS). AFS is a truly unique product in the form of “smart glasses”. These glasses are a very useful tool for biomanufacturing that enables increased efficacy and productivity, while at the same time increasing adherence to procedures and safety. As I began talking with Gary Pignata, Co-founder/Partner of AFS, about all the ways you could use these glasses the applications seemed to grow exponentially. I have outlined a few of the main applications below.

Tandem is an application that allows others to see what the operator or engineer is seeing in real time. The person in the facility puts the glasses on and then the support engineer or others can log in on their computer and see exactly what the person on the manufacturing floor is seeing. This allows for a remote troubleshooting interface and allows the support engineer not in the facility to see problems, provide real-time feedback and solutions to on the floor staff. Another opportunity for this technology is in training. Trainers can use live remote viewing to train multiple locations at the same time. This eliminates the need for training travel expense and travel time and increases consistency by ensuring every employee is seeing the same training simultaneously.

The Manuals feature allows users to see SOP’s, batch records, manuals, job plans, etc. displayed in the glass lens. This is perfect for hands free, step by step procedures that operators can view even if they are gloved or have their hands full. The idea is that this will greatly reduce scientist/operator error by having access to these materials on the spot. It will also save time, as users don’t need to remove gloves or their hands from the hood to turn the page or view multiple documents.

Last, the Gauge features gives operators a gauge reading so that readings can be more consistent across multiple operators. In addition, it can provide warnings to not open equipment that is tagged out or is still in operation. It is designed to improve consistency, reporting and maintain safety.

UVC LED for Sterilization, Cleaning Validation, Process Control and so much more!

One of my stops at BPI led me to learn a bit more about an interesting technology – UVC LED (Ultraviolet light emitting diodes). I was fortunate to be able to speak with Hari Venugopalan, Director of Global Product Management, Crystal IS. UVC LEDs are increasingly being used to sterilize connection points in biomanufacturing as they offer a very attractive alternative to manual sterilization operations. However, they also have other beneficial uses in biomanufacturing as well.

Sterilization:

UVC LEDs provide a compact, portable way to ensure sterilization without the additional problems that traditional methods, including high temperature and chemical sterilization, cause. It works by utilizing the UV light to break the DNA bonds in microbes, including bacteria and viruses, and render them inactive. The LEDs enable the sterilizing of multiple connection points simultaneously.

Cleaning Validation:

UVC LEDs can also be used to verify cleaning between manufacturing process by using UV light induced fluorescence of rinse water. The use of alternatives such as HPLC are expensive and time consuming and may create downtime while acceptable residual limits are validated.

Process Control:

UV absorbance can also be used to control onset and end of protein/antibody purification processes.

Water Quality Monitoring:

UV absorbance can also be used to monitor total organic content (TOC) of water and ensure the appropriate water quality is being used.

mAbVault

Another interesting offering this year was the launch of the new contract antibody manufacturing service, mAbVault. mAbVault is a network of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) with expertise in hollow fiber bioreactors (HFBR). HFBR is a technology platform that has demonstrated consistency in yields and quality, minimized start-up costs and seamless scale-up.

What makes mAbVault unique is that they are offering a fixed price for the life of the product, through all regulatory stages. This approach eliminates up-front protein development and technology transfer expenses. Protein owners pay only for delivered product, thus reducing overall production expenses by up to 60% versus ascites, rocking bioreactors and tanks.

Additional advantages of mAbVault

Inventory expenses are kept off the books through delivery
mAbVault vetted CMOs are GMP-compliant facilities that employ experts in hollow fiber technology
Second site production and storage is standard
Over 1700 organizations served globally and 2700 cell lines expanded – through all stages of regulatory compliance
Robust supply chain systems already serving top global therapeutic and diagnostic organizations

For more information please see the guest blog, “Cool Tool – mAbVault for Antibody Manufacturing: Protect Quality, Minimize Expenses, and Simplify Scale-up.”

IDBS – Data Management

One company looking to simplify data management and provide better tools for data driven decision making is IDBS. IDBS is a software provider that enables companies to securely capture, manage and share their data. While they offer tools specifically designed for biologics development, the key component is the E-WorkBook platform, which enables companies to effectively collaborate and share data with key stakeholders.

Some areas where this system has been beneficial for biologics include:

Providing an overview of products and processes as well as offering traceability and insight into key aspects of the process.
Enabling communication between upstream and downstream groups, analytical, QC, etc., due to the easier accessibility of data.
Delivering a framework and data in which to optimize process development and correct or prevent errors.
The ability to search data with more context, thereby generating more valuable results for report generation, managing IP and technology transfer.

Earlier this year IDBS launched E-WorkBook 10 that overhauled the existing E-WorkBook and provided “new ways to visualize, present and consume data, including enhanced charting and canvasing capabilities.” These updates have provided an intuitive structure for data input and reporting. In addition the update has made E-WorkBook accessible through the web to increase access of data to multiple devices and from multiple locations.

For more information on IDBS, please see their guest blog “Biologics Development: How do you Solve a Problem Like Data Management?”

Unchained Labs

When I first stopped by the Unchained Labs booth at BPI the first thing that struck me was the innovative booth design and marketing of the company. When I stopped in to talk, I quickly realized that their booth wasn’t the only innovation they had to offer. Launched in early 2015, Unchained Labs is a fairly new biologics tools company, with three products.

The first called the UNit, is a powerful biologics stability screening platform. The UNit allows researchers to examine protein stability parameters and provides more information about formulations to speed the time to candidate selection. It has the ability to measure melting and aggregation onset temperatures at the same time. The UNit has 7 applications total and can run up to 144 samples a day with just 9 μL needed per sample. It measures the whole fluorescence spectrum for proteins, providing a complete picture of stability. At the same time it monitors aggregation by static light scattering at two wavelengths, making sure it is possible to see both small and large aggregates. The UNi consumable used on the UNit, lets you measure 9 µL of each sample, you can run up to 48 samples at a time and each sample is sealed air-tight, so runs can be short or long.

Unchained Labs’ next product, launched in June, is called the HUNK, a platform that completely automates the chemical denaturation and protein stability measurement process. Easy set up in application-specific trays is all it takes to get started. Once the HUNK gets going, it can process up to 96 ΔGs on 96 different conditions fully unattended. The higher the ΔG, the more stable the protein. After determining ΔGs, researchers will have the facts needed to determine whether or not it’s worth spending time on minimizing aggregation or optimizing solubility and viscosity. The HUNK also monitors the change in ΔG over increasing protein concentrations, and gets the ΔG _trend . This trend can tell researchers whether their protein will aggregate and if it does, whether it aggregates from the native or denatured state. By understanding how the protein will aggregate, scientists can take steps to correct the problem in advance. This is new insight not available in other tools.

In July, they launched the pUNk system, the smallest and fastest protein sizing system that I’ve seen. The pUNk system uses dynamic light scattering (DLS) to measure a protein’s hydrodynamic size, size distribution, aggregation population and molecular weight. The system is enabled by the low-cost rUNt single-use consumable and only requires a 5 μL sample size.