Achieve operational excellence and reduce compliance risk with insights into key operational performance indicators

Real Results

CASE STUDY
We helped a leading biologics company reduce batch cycle times by 30%.

Smart Connected Operations delivers measurable business outcomes

  • 10-15% reduction in tech transfer and scale-up timelines
  • 10% OEE improvement
  • 10-25% increased productivity
  • 10-40% reduced maintenance cost
  • 15-30% faster resource tracking
  • 10-12% improved labor efficiency
  • Faster time to market

We help pharma and biotech manufacturers connect machines, devices and workers across the value chain and apply data science to enable smart connected operations.

With increasing regulatory scrutiny, ensuring continuous process and materials quality in pharma and biotech manufacturing is as important as ever. As gene and cell therapies push the industry towards personalized medicine, there is a need to bring new drugs to market in shorter times and with decreasing batch sizes. The margin for error or iterations is shrinking.

The legacy of siloed functions and operations inhibits innovators from meeting market expectations.


Smart connected operations answers these challenges by leveraging digital technologies across product development, manufacturing, operations, and supply chain to increase connectivity. Establishing a digital thread across functions and applying data science enables the creation of manufacturing control towers across distributed facilities, lines and equipment. This generates real-time insights for faster and better decision-making, ensuring efficacy, increasing efficiency and safety across the extended value chain, while also simplifying compliance and process validation.

This necessary shift represents more than just an approach to digital technologies. Smart connected operations is also a means of transforming the workforce. From connecting workers to more human-centric workflows, to shifts in company culture, humans are at the core.

How We Help Clients Build Smart Connected Operations

Our approach focuses on converging systems across the enterprise, applying data science and human centric process design to drive more throughput and gain real-time insights across the value chain. Putting the right information at the right time in employees’ hands helps them improve operational decisions and increases their job satisfaction.

In pharma and biotech, we commonly converge data from information technology systems such as ELN, LIMS, PKM, DKM, RIMS and others to MES, SCADA, DCS, PLC and sensors on the operational technology (OT) side.

Three Key Phases to Digitizing Your Operations

Mechanical to Digital

  • Deploy IIoT platform
  • Establish connected control system foundation
  • Enable continuous improvement

Reactive to Predictive and Prescriptive

  • Optimize manufacturing monitoring and control systems with machine learning
  • Improve manufacturing performance through predictive and prescriptive analytics

Organize to Scale

  • Establish repeatable installation playbook and operating model
  • Develop knowledge and skillsets in the organization to scale capability across the manufacturing portfolio

Our Smart Connected Operations approach aligns with Pharma 4.0 strategies and extends the associated smart factory investments and benefits.

What is Pharma 4.0?

Pharma 4.0 is an operating model developed by the International Society for Pharmaceutical Engineers (ISPE) to adapt Industry 4.0 strategies, also called Smart Factory, to the unique requirements of the pharma industry. It aims at enabling organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of patients.

Close

Pharma 4.0 is an operating model developed by the International Society for Pharmaceutical Engineers (ISPE) to adapt Industry 4.0 strategies, also called Smart Factory, to the unique requirements of the pharma industry. It aims at enabling organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of patients.

Pharma 4.0 is an operating model developed by the International Society for Pharmaceutical Engineers (ISPE) to adapt Industry 4.0 strategies, also called Smart Factory, to the unique requirements of the pharma industry. It aims at enabling organizations involved in the product lifecycle to leverage the full potential of digitalization to provide faster innovations for the benefit of patients.

High Impact Pillars of Smart Connected Operations in Pharma & Biotech

Product and Process Development

Digitalization of product, packaging, process and recipe development to improve technology transfers from the lab to clinical materials development through commercial drug product development and to accelerate scale-up across the manufacturing network.

Resource Optimization

Improve overall manufacturing productivity and resource allocation with optimization algorithms for labor, materials, lines and equipment planning and scheduling.

Manufacturing Simulation & Emulation

Design and validate manufacturing processes by authoring, re-using, simulating, and optimizing automation-design based on fully realistic kinematic behavior.

Process Control Optimization

Improve process control, production rate and product quality with prescriptive machine learning algorithms including soft sensors and lineside next best action.

Production Performance Management

Drive OEE improvement and lean production management with centralized and localized manufacturing control towers powered by real-time metrics.

Asset Performance Management

Increase asset uptime and performance by leveraging AI to detect and predict faults, and prescribe mitigation activities.

Plant & Equipment Line Commissioning, Changeover, Clearance, Operations

Enable centralized equipment support and maintenance, safer repair work, and rapid spare parts identification with augmented reality and object recognition.

Energy Management & Sustainability

Achieve sustainability goals and improve the bottom-line with industrial IoT and advanced analytics, enabling smart facilities with real-time visibility, monitoring, analysis and control of energy, water, air, gas and steam.

Core Areas for Applying Digital Technologies to Enable Smart Connected Operations

Technology Transfer and Scale-Up

Continuous Process Validation (CPV)

Soft Sensors

Line Commissioning, Clearance, Changeover

Lineside Next Best Action

Yield Optimization and OEE Improvement

Manufacturing Control Tower

XR Augmented Weigh and Dispense Operations

Technology Partners

CASE STUDY

We helped a leading biologics company reduce batch cycle times by 30%.

Our client sought to improve the quality and performance of their production process with real-time analytics insights.

Prior manufacturing process was based on estimates and manual checks at set times resulting in scrap.

We deployed predictive models that converge real-time independent variables (air temperature, fan speed and humidity) and dependent variables (ideal moisture) with historical batch crystal formation data to continuously predict outcomes with 95% confidence.

Operators now can use on-the-spot data and model based predictions for more reliable outcomes.

Our work improved process control, production rate and product quality, while reducing batch cycle times by 30% and scrap or waste by 5%.

Thought Leaders

Sachin Misra 2014
Principal & Global Leader - Pharmaceutical, Biotechnology and CDMO Practice