aleph for pharmaceutical manufacturing

Optimise cycle times and prevent deviations that impact product quality

Innovation

Accelerate innovation for faster time to market

Quality

Deliver high quality product consistently

Compliance

Adhere to regulatory standards
Supported industries
Various leading pharmaceutical manufacturers have benefited from Aleph AI Co-Pilot
Pharma Product Development (PPD) & Chemistry, Manufacturing, and Controls (CMC)
Small Molecules & Active Pharmaceutical Ingredient (API) Manufacturing
15-20%

Enhanced product quality

Consistent achievement of desired product output quality
20-30%

Reduced defect rate

Decrease material waste and batch reword costs
50-60%

Faster scale-up time

Streamline tech transfer process, accelerating lab test to commercial production

Optimization of Product Quality for an API Manufacturing Plant

Context

An Active Pharmaceutical Ingredient (API) manufacturing plant was not able to identify issues with its separation process including a crystallizer and associated ancillary equipment, which resulted in increasing off-spec product quality.

Solution

The plant used Aleph AI Co-Pilot platform to predict batch output quality and alert the users on potential deviations, including the diagnosis of the potential causes. The plant has also been relying on Aleph AI’s recommendation to ensure swift response against quality deviations.

Outcome

Aleph AI identified the initial causes as suboptimal operating conditions on impeller speeds of compactors and feed flow rates. Aleph AI Co-Pilot has since been generating recommendations to prevent quality deviation for the plant, enabling a 21% improvement on output quality.

Enhancing Scale-Up and Tech Transfer in Pharmaceutical Manufacturing

Context

A leading pharmaceutical company sought to accelerate its process of transitioning from lab- scale to full-scale commercial production. Key goals included maintaining consistent product quality, identifying optimal process and operational parameters to reduce variability, and ensuring a seamless tech transfer from R&D to production.

Solution

Aleph AI Co-Pilot platform has been used to create digital twins of lab-scale equipment, allowing for detailed process analysis. Aleph AI was then deployed on the digital twins to conduct adaptive virtual experiments, which guided physical trial runs. Data from these trials enabled optimisation of the scale-up design, improving key metrics such as capacity, yield, and efficiency.

Outcome

With Aleph Digital Twins and AI, the company reduced the number of physical trials by up to 50%, accelerating the scale-up process from lab to commercial production by 20-30%. This approach provided optimised process designs in a fraction of the time, enabling faster, more efficient tech transfer.

Reducing Reworks & Off-specs in the Spray Drying Process for an API Production Plant

Context

An API manufacturing plant faced issues in its spray drying process, specifically on critical parameters, such as inlet and outlet air temperatures, atomization pressure, and airflow rate. Therefore, this led to inconsistent drying, poor product quality, and a high frequency of reworks.

Solution

The plant used Aleph AI Co-Pilot platform to monitor, predict, diagnose, and alert off-specs in the drying. Subsequently, Aleph Co-Pilot system has constantly been supporting the operators by recommending corrective actions in terms of feed rate, temperature, atomization, etc.

Outcome

The causes of the initial issue identified on inconsistent air temperature, air flow rates, and fluctuation in atomization. Aleph AI Co-Pilot has assisted the plant to constantly achieve the desired drying spec; thus, reducing the rework and off-spec rates by 30%.

try aleph’s co-pilot today

Are you also facing similar challenges and looking to solve them?

Sign up for Beta