Tracking Raw Materials in Biopharma Manufacturing

Raw material tracking is a crucial component of making a quality product efficiently. Supply-chain visibility and documenting that raw materials meet quality specifications are both important. 

“Pharmaceutical and biotechnology companies have similar issues to other industries, but the stakes are much higher because they treat patients,” notes Richard Soltero, president of InstantGMP, which offers software for GMP manufacturing. “Each player along the way has an onus to put only quality materials into the supply chain. Every company must remove any poor-quality materials before products end up in the hands of providers and patients. In addition, the complexity of the supply chain makes tracking and tracing materials difficult.”

“Maintaining consistent, high quality in both the supply chain for materials and in the end products themselves are two major challenges in raw materials management for biopharmaceutical manufacturers,” says Dr. Nandu Deorkar, vice-president, Technology & Innovation at Avantor. “These foundational items can present issues when trying to establish a reputable supply and identify true second sources with suppliers that have well-documented processes.”

Best practices

Understanding the supply chain is crucial. “Long lead times can be a challenge for certain raw materials,” notes Deorkar. “It is important for manufacturers to work with their suppliers to understand their outlook and foster investments to increase critical capacities worldwide. Additionally, managing the correct methods for packaging and process efficiencies is also critical for handling materials, reducing demands on storage at facilities, and reducing the capital expenditures required at new facilities.” 

Avantor has implemented flexible packaging sizes to help its biopharmaceutical manufacturing customers. Modular packaging systems enable quicker turnaround for customers to use the materials in production. Preweighed materials in ready-to-use packaging allow companies to reduce storage of bulk or hydrated buffers as well as reducing testing and material handling processes. 

Deorkar notes that another best practice is transparency for the supply chain and for management of change procedures for current good manufacturing practice (CGMP) materials. Adoption of electronic data systems enables this practice. 

Electronic data

Although the bio/pharma industry has traditionally used paper-based tracking systems, leading manufacturers are transitioning to electronic systems, which offer significant benefits for efficiency and quality, as part of digitalization efforts. 

“It’s important to have full supply-chain visibility and management of change across the entire supply chain during the manufacturing process, and this is where data [are] coming in to help,” agrees Claudia Berron, senior vice-president, Biopharma Production at Avantor. “The new frontier of biopharma is being driven by e-data: the electronic delivery of critical documents related to the material, with full tracking capabilities by package and by pallet. As the industry is adopting this technology, it is benefiting from the experience of other industries that are more advanced in this space.”

“Paper-based documentation can be problematic when tracking and managing materials through the production process,” explains Soltero. “In a paper-based system with different information kept in different locations, people can find themselves spending valuable time verifying material status and inventory levels or tracking down the right person. Manufacturers can avoid these problems by transitioning to a cloud-based inventory software that automates material tracking, inventory levels, material statuses, purchase orders, and staging materials for production.”

Using inventory management software enables automation of material receiving and specifications, says Soltero. Automation eliminates human errors and helps to remove poor-quality materials before they enter inventory,  and it can be used to maintain inventory history in real-time. “In InstantGMP’s inventory software, each material has a unique profile and a system-generated receipt number that comes with a barcode label to check materials throughout the production process,” explains Soltero. “The real-time status update alerts personnel that material is ready for use, where it is, how much is available, from what vendor, and what the vendor lots are. Every use of inventory or change appears within that material’s inventory record.” 

A new software feature for material resource planning includes the ability to make a picklist. “Through the picklist, manufacturers can start allocating materials for production, setting materials aside to prevent confusion, verifying stock level and material status, preventing double counts, and performing additional quality reviews. Picklists can be used for bridging the tracking gap in assembling kits and for those that want to take advantage of traceability within the software but want to connect data to their legacy system,” says Soltero. The software is designed to work in tandem with other systems, including paper-based systems, to help companies that are transitioning to electronic systems. “We understand that a full transition to another system, electronic or not, is a huge undertaking and can be disruptive to production until everything’s in place,” he says. InstantGMP’s software has an inventory import function, and data can also later be added to modules such as software for electronic batch records. 

Cell and gene therapy tracking

AI enables supply-chain visibility

Cloudleaf uses intelligent sensor networks, artificial intelligence (AI) with machine learning, and advanced analytics to provide supply chain visibility. The company is expanding its Digital Visibility Platform (DVP) to provide continuous, real-time visibility for the supply chain.

“Currently visibility in the supply chain industry is at best only about 20%. DVP can take this to 100% visibility,” claims Mahesh Veerina, CEO of Cloudleaf.

In bio/pharmaceutical manufacturing, the sensors can be attached to raw material containers, which track their location as well as additional environmental information, such as temperature, vibration, and shock. Read more about the use of Cloudleaf’s platform in processing blood plasma.

The emerging space of cell and gene therapy manufacturing, especially patient-specific autologous therapies, requires even more stringent control over raw materials and the entire supply-chain and manufacturing workflow. New systems have been launched to address these specific challenges. 

For example, GE Healthcare’s Chronicle automation software is designed for cell therapy process development and manufacturing. The software supports real-time data acquisition and notifications for supply chain logistics, electronic batch records, and electronic standard operating procedures (1).  

TrakCel supplies software for cell and gene therapy supply-chain tracking and has announced several partnerships with industry members. Most recently, the company announced a collaboration to integrate McKesson’s third-party logistics and patient access services with TrakCel’s tracking systems (2). In June, TrakCel announced a partnership with Be the Match BioTherapies to integrate services and platforms (3). TrakCel is also a partner in a project in the United Kingdom supported by Innovate UK, the Standard Approach to ATMP [advanced therapy medicinal products] Tissue Collection (SAMPLE programme) (4). The project will study cell and tissue procurement, processing, and storage processes.  

Data transfer and insight

GE Healthcare and Amgen announced a digital data exchange programme in early 2019 that aims to use raw material data to increase process understanding of the relationship between raw material variability and process performance (5). The data exchange is intended to improve transparency, identify root causes of variation, and improve quality of both raw materials and the final product. GE Healthcare is developing electronic certificates of analysis (eCoAs) using ASTM International’s standard for raw material electronic data (e-data) transfer (6). The ASTM standard grew out of work that originated at Amgen on a standard file format to allow data exchange between raw material suppliers and users (7). 

The ASTM e-data standard provides a baseline, but there is work yet to be done, says Berron. “There is still a significant effort required to establish direct e-data connectivity for the electronic delivery of critical documents including CoAs. By enabling CoA e-data instead of PDFs, the data source is ready to retrieve or push to the customer’s system, enabling a quick turnaround in troubleshooting efforts and seeding new efforts for predicative analytics of raw material impacts into the process.” 

“It’s all about material control, transparency, and traceability,” concludes Soltero. “Non-electronic solutions are rife with opportunities for materials to get lost, to be improperly tested, and to have gaps in traceability. Manufacturers are the last stop in the supply chain before products get to distributors and patients, and that makes it imperative for producers to have complete control and total traceability.”

References

1. GE Healthcare Life Sciences, “GE Healthcare Announces Commercial Launch of Chronicle Automation Software for Cell Therapy,” Press Release, 15 May 2019.
2. TrakCel, “McKesson and TrakCel Launch Innovative Collaboration to Support Commercialization of Cell and Gene Therapies,” Press Release, 11 Sept. 2019.
3. TrakCel, “Be The Match BioTherapies and TrakCel Partner to Standardize Cell and Gene Therapy Supply Chain Solutions,” Press Release, 18 June 2019.
4. TrakCel, “Government Boost for Expanding the Use of Cell and Gene Therapies in the UK,” Press Release, 18 April 2019. 
5. J. Markarian, “Data Insights Improve Process Reliability,” PharmTech.com, 3 May 2019.
6. ASTM, ASTM E3077-17e1, Standard Guide for Raw Material eData Transfer from Material Suppliers to Pharmaceutical & Biopharmaceutical Manufacturers (2017). 
7. C. Undey, “Amgen’s Digital Transformation: Linking Raw Material Data from Suppliers to Patients,” GE Life Sciences,  March 2019.