Mfg News: Pfizer and Sandoz

A roundup of manufacturing news from Pfizer and Sandoz.

Pfizer, Amazon Partner for Clinical Mfg
Pfizer is working with Amazon Web Services (AWS), an, company, to create cloud-based solutions with the potential to improve how new medicines are developed, manufactured, and distributed for testing in clinical trials.

The companies are exploring these advances through their newly created Pfizer Amazon Collaboration Team initiative, which applies AWS capabilities in analytics, machine learning, compute, storage, security, and cloud data warehousing to Pfizer’s laboratory, clinical manufacturing, and clinical supply-chain efforts. 

AWS is helping Pfizer enhance its continuous clinical manufacturing processes by incorporating predictive maintenance capabilities built with AWS machine-learning services, such as Amazon Lookout for Equipment, AWS’s service for detecting abnormal equipment behavior by analyzing sensor data. As a result, Pfizer says it can maximize uptime for equipment, such as centrifuges, agitators, pulverizers, coaters, and air handlers, used in clinical drug manufacturing.

AWS is also working with Pfizer to develop a prototype solution for detecting abnormal data points in its drug-product continuous clinical manufacturing platform for solid oral-dose medicines. The machine learning models used in the prototype were able to provide early warnings for alarms with minimal false positives, and direct users to the relevant signals. As a result, Pfizer can process data from the equipment and sensors involved in portable continuous miniature and modular manufacturing to detect anomalies as they occur, predict maintenance needs, and reduce potential equipment downtime.

Source: Pfizer

Sandoz Recalls One Lot of Anticoagulant
Sandoz, the generics and biosimilars arm of Novartis, is initiating a recall of one lot of enoxaparin sodium injection, USP 40 mg/0.4 mL single-dose syringes, an anticoagulant, to the consumer level due to a portion of the lot experiencing a temperature excursion during shipment.

According to the US Food and Drug Administration, the exposure to higher temperatures may have impacted the recalled product’s effectiveness and may pose reasonable probability of risk for patients with health conditions that the product is intended to treat. To date (as reported on December 1, 2021), Sandoz has not received any reports of adverse events or injuries related to this recall. The lot of enoxaparin sodium for injection was shipped to customers in the months of September 2021 and October 2021.

Source: US Food and Drug Administration