Binocs is a product by bluecrux. Already from the start in 2011, bluecrux collaborates and co-creates with clients that are leaders in their markets. This has resulted in two innovative platforms: Binocs and LightsOutPlanning.   Also, global industry watchers and industry consultants follow our moves. BCG positioned Binocs in their...

Increasing QC on-time delivery, throughput, efficiency, utilization and employee wellbeing starts with measuring and visualizing current performance. Because: What gets measured, gets managed. Binocs comes packed with out-of-the-box dashboards that can be customized to your needs. We highlight a few below. Contact us for a demo so we...

[blockquote text="The Global Cell And Gene Therapy Market Is Estimated To Be Worth More Than £35Billion By 2026." text_color="#484848" width="auto" line_height="100%" background_color="#C0C0C0" border_color="red" show_quote_icon="yes" quote_icon_color="white"] With the past year seeing Kite Therapeutics and Novartis make headlines for their groundbreaking therapeutic approvals, and a host of innovative...

Making Binocs EPIC!  Before joining the Binocs team in August, Adam spent 7 years as a consultant in the field of healthcare technology innovation in the UK. In the course of his career, he has helped clients to enhance their digital products for the personal health market and, as a result, has become increasingly involved in developing user experience (UX) strategy. Here he reviews the background to the...

We’re excited to finally share the news that we’re opening our first US office in New Jersey to support companies to digitally transform their value chains. We will be using our software to support the pharmaceutical sector in the US, by enabling scientists and lab...

Let data lead the way with the Binocs performance twin Planning and executing efficiently works better when it’s driven by data. With the Binocs performance twin, you get instant access to data analytics in Binocs. Seamlessly integrated Data can come from anywhere — Binocs, LIMS, RIMS, ERP, … It’s...

How to plan QA teams (for batch release) This blog defines, in a high-level way, the scope and the challenges faced by QA release teams and how we, using Binocs, can face these challenges. Let’s start and situate the case. What do we understand with Batch release? To release a...

GSK Vaccines Global Regulatory Affairs (a team of 400+ people) presented their experiences with Binocs resource planning at the Making Pharmaceuticals conference that was held in Brussels on March 14th. Why did GSK GRA implement resource management? Why did GSK GRA choose for Binocs? And...

A very interesting article by Mark Mortensen and Heidi Gardner about organizations where senior managers and team leaders are increasingly frustrated by conflicts arising from what is referred to as multiteaming—having their people assigned to multiple projects simultaneously. With Binocs we share their vision. We have...

Business context  We are a global regulatory affairs department that submits 1000+ submissions/year. We need to make and support delivery commitments to regulatory authorities and our internal supply chain and production partners. It is an understatement when we say that this is challenging. Improvement potential  Before we implemented...

In a recent report, Michael Shanler summarized recommendations for the digitalized lab of the future. (“Life Science’s Lab Informatics Digital Criteria to Separate Vendor Leaders From Laggards”, 20 December 2018, link requires registration). When we scan for visionary reports on lab informatics, we get stuck in...

Cell and gene therapies are here, and they’re here to stay. In the last couple of years, very promising results were achieved. Examples include treatments for certain blood cancers that helped patients for which all other available therapies had failed. Another example is a treatment for a genetic mutation that causes blindness.

How does it work?

An example is CAR-T therapy which is in essence (without trying to be complete or scientific) something like this:

  • Cells are harvested from the treated patient
  • In the lab, cells are genetically modified and cultivated
  • The manipulated cells are re-administred to the patient
  • The manipulated cells can then recognize and destroy tumor cells in the patient and initiate a broader immune response.

New challenges ahead

The novelty of highly efficacious but highly complex and expensive cell and gene products is disrupting every element of the route to commercial success including supply chain needs, reimbursement models, and more.

Manufacturing processes are completely different from what the life sciences industry is currently used to. Whereas in standard manufacturing big batches are produced to stock, cell and gene therapies manufacture batches of 1 (per patient).

These batches need to be produced in a very limited timeframe. When cells are collected from the patients, it is critical that the cells have somewhere to go, that there’s manufacturing capacity available.

It’s also about scheduling and balancing cell collection with manufacturing and infusion dates to have a more efficient supply chain, which should impact favorably on the cost of those therapies.

One could question why the conventional leading solutions in supply chain and production planning and scheduling (APS software solutions such as OMP, Kinaxis, SAP APO and others) cannot be used. At Bluecrux we implement such solutions in commercial supply chains. Such solutions thrive on footprint and robust processes. That is not what CGT is. We confirm that there is not a single conventional supply chain concept that cuts it for CGT plants. To meet planning and scheduling requirements, we are talking about a radical conceptual change.


How to tackle the planning and scheduling?

Through three implementations that started in 2018 in the domain of lab scale production, we discovered that Binocs covers quite some of the planning and scheduling requirements. Extending Binocs to CGT is a linear step:
  • Binocs resource planning and scheduling run in different research-scale cell culture environments (Merck, GSK, UCB, …)
  • Many of the cell and gene therapy manufacturing processes run currently as scaled-up versions of the cell culture processes. The steps described below are based on our experience in these environments.
  • However, the CGT manufacturing processes are changing rapidly. We’re rooted in co-creation and are starting projects with clients to enhance Binocs to meet the unique needs of CGT environments even better.

1. Plan for growth

As demand for patient treatments is increasing, so will the need for a robust and industrialized process. Asset utilization of clean rooms and bioreactors will become a challenge as it requires a delicate interaction between processes and qualified technicians. Therefore getting control through a tight planning process is required:

  • Using the Binocs equipment planner different batches are planned and equipment reserved.
  • Planners can run what-if scenarios and test different plans
  • Planners stay in control and update the planning, but get immediate feedback of overbookings or periods of over/under capacity.

Binocs covers end-to-end activities. This way planners can promise manufacturing slots, which in turn triggers the upstream processes (doctor, patient, logistics) to plan the cell harvesting accordingly.

2. Scheduling technicians

The different manufacturing steps are configured in Binocs with the correct timings and lead times. Based on this configuration the Binocs algorithm will schedule technicians and equipment taking into account qualifications, availability and other constraints.

This will give the technicians a one-stop overview of their planning on the Binocs planboard.


3. Plan the Quality control in one system

Binocs is the leading in the domain of QC resource planning and scheduling. So not only the manufacturing department, but also the QC analysts can be planned using Binocs. The different QC tests (e.g. PCR sterility test, mycoplasma) can be configured similarly in Binocs and scheduled on the plan board. As also QA release activities, reagent and media preparation, validation activities, etc can be covered, Binocs can be considered as the digital twin of the CGT plant. All the activities in and around the CGT plant are visible in one system: the past (actuals), the present (progress status) and the future (planning).


4. Interfacing with other systems

The visibility of the entire cell therapy process — from initial material collection to final treatment, is the new challenge. We need to avoid the time, cost, and risks associated with outdated paper-based systems. Therefore manufactoring Execution Systems (MES), Logistics Systems  as well as lab systems (LIMS/ELN) are needed by which program-critical information can be collated, tracked, and documented.

System such as Vineti or TrakCel offer platforms to do this. CGT manufacturing planning software such as Binocs is specifically designed to send and receive data to these platforms to give real-time visibility on manufacturing planning.

Based on our experience at clients in Cell culture, Clinical trial and QC departments we’re expanding (in co-creation with leading pharmaceutical companies) the resource planning and scheduling software Binocs to fully support Cell and Gene therapy manufacturing planning.

Stay tuned to see what we’re cooking up.

Business context We are a department of about 450 people. 70% of our work are projects that can be sub-divided into 12 project types with a standardized template. We execute about 1500 projects/year. Our performance drivers are productivity and planning adherence. Improvement potential Projects are supported by different teams...