Welcome to our annual celebration of the great and inspirational minds that contribute to the development and manufacture of new medicinal products
The Power List 2022 focuses on the top 10 VIPs in three key categories of medicine making
How does digital transformation create a competitive advantage for customers and emphasize Bachem’s technical leadership role in the TIDES CDMO field?
The fourth industrial revolution has started slowly in the pharma and biotech sectors, but more and more companies now embrace digital transformation in operations and supply chains (1). At the beginning, the drivers for digital innovation were cost savings and productivity, but there are many business cases beyond financial KPIs. For example, improved flexibility in capacity allocation and production scheduling can shorten time to market for new modalities, such as oligonucleotides. Oligonucleotides are a growing sector of the market, with 15 products already approved and more than 900 products in preclinical and clinical trials. Both the market and demand continue to grow, and digital transformation represents a great opportunity for CDMOs to keep pace with the dynamic landscape.
As the technology-leading CDMO for peptides and oligonucleotides, Bachem sees digitalization as an enabler to meet changeable demands, compliance, and ambitious timelines for high-quality APIs. Taking the automation pyramid (see figure 1) as a framework, digitalization projects are required in all layers in the digital transformation journey of pharmaceutical operations towards Industry 4.0.
One of our recent digital transformation lighthouse projects was the full automation of the industrial solid phase peptide synthesis (SPPS) process. To this end, the first Bachem robot-operator was designed and programed to execute the complete amino-acid activation and addition step. A key component of the automated equipment train is process analytical technology (PAT), which enables inline monitoring after key steps. With PAT, the need for manual in-process controls is omitted while ensuring real-time control of critical process parameters.
In addition to full automation, we digitalized our SPPS process by integrating the control system of the production floor (levels 1 and 2; see figure 1) with a manufacturing execution system (MES, level 3), and the enterprise resource planning (ERP) system (level 4).
The MES has three major tasks:
In the context of vertical integration, the MES interconnects with our ERP system. Material verification, execution of process orders, creation of manufacturing orders, automatic stock creation, and material flow are all tasks that are now fully automated and paper-free. The risk of human error, such as material loss or mix-up, is omitted.
The process means that we can ensure that the correct material is used at the correct process step, as well as a reliable stock and inventory management generating a single source of truth in the ERP system.
All process data is logged in real time in the plant information (PI) system, which is a data Historian platform. This platform enables long-term archiving of process data, batch data, and facilitates data analytics, process optimizations, or root cause investigations. Both MES and PI systems are being rolled- out company wide.
Entering the era of pharma 4.0 demonstrates our commitment to our customers. Bachem has made huge steps in ensuring swifter interaction, more flexible production, and documentation sharing. With these newly integrated systems, we increase our capacity and speed by streamlining GMP documentation while boosting our processes’ efficiency regarding quality, cost, and time. Digital transformation will allow us to meet the increasing demand for new modalities and increase the speed with which these new therapies can reach the market. Thus, we will help our customers in their mission to reach large patient populations and to transform as many lives as possible.
CDMO: Contract Development and Manufacturing Organization
Click here to learn more about Bachem
When you click “Subscribe” we will email you a link, which you must click to verify the email address above and activate your subscription. If you do not receive this email, please contact us at [email protected] . If you wish to unsubscribe, you can update your preferences at any point.
Specialist Marketing at Bachem AG
Elodie Decuypere received her Ph.D in Organic Synthesis from the University of Paris-Saclay with specialization in Click Chemistry. After her Ph.D, Elodie specialized in oligonucleotide chemistry with her two postdoc in ETH Zürich and Roche Basel. In 2020, Elodie joined Bachem as a Specialist Marketing and works on the creation of scientific content for marketing materials.
06/22/2020 | Sponsored by Thermo Fisher Scientific
Register to access our FREE online portfolio, request the magazine in print and manage your preferences.
A Tale of Two Continents
The Early Bird Gets the…
Words With the Fearless Leader
© 2022 Texere Publishing Limited. All rights reserved. Reproduction in the whole or in parts is prohibited.