The COVID pandemic has led to a spotlight focus on parenteral operations capabilities and capacity as the industry responded in an unprecedented manner to the need to innoculate billions of people. Leveraging and scaling technologies and adapting at speed to the emerging therapeutic and vaccine needs has driven a ‘barrier breaking’ mentality within companies and as illustrated by these three case studies the results were spectacular. The presentations will enable attendees learn about approaches to agile and innovative execution that are hopefully also applicable to other technology platforms.
VP, Sales and Account Relationship Management
Chief Manufacturing Officer
Principal Technical Affairs Manager
Corning Pharmaceutical Technologies
Director of Sales – Pharma North America
OPTIMA Machinery Corporation
Vice President of Manufacturing Operations
Ampio Pharmaceuticals Inc
[Adaptive and Agile Pharmaceutical Manufacturing through Cognitive Cyber-Physical Eco-system]
Speaker: Ramy Harik
The unforeseeable COVID outbreak is demanding drastic capacity from the US pharmaceutical industry, where severe drug shortages and large-scale vaccine (and eventually booster) production are unprecedentedly challenging the agility of the global supply chain, resource planning, decisionmakers, and production facilities. Empowering facilities to autonomously discover, plan and control dynamic production schedules driven by governmental drug shortage listings and emergent surgery priorities, will inject the current pharmaceutical manufacturers with new vitality to undertake life-saving responsibilities. This talk discusses a complete cognitive eco-system of digital twins, PharmaNext, which will capture, analyze, understand, and adapt pharmaceutical production facility status, perform edge analytics, identify anomalies, and elevate enterprise intelligence to prescriptive analytics level through an innovative autonomous semantic integration philosophy.
[Glass Packaging & Equipment Technologies Augments Manufacturing Capacity]
Speakers: Matt Hall and Mevluet Yilmaz
High-speed liquid pharmaceutical fill/finish is essential for the production of high-volume drugs. Maximum filling speeds in the industry can be limited by several non-mechanical factors, including manual container loading, micro stops and commodity quality. Recent innovations in primary glass packaging technology offer solutions to several of these historical limitations. These limitations include damage resistance that decreases glass particulate generation and cosmetic defects, reduced friction on the line that improves operational efficiency, and inherently increased strength that limits breakage and reduces line interventions. An overview of the science that enables these innovations will be provided, followed by a case study from a commercial filling line trials along with aggregate throughput data that quantifies the operational benefits that can be realized with innovative glass packaging. In the latter section, we will provide a look into how a leading equipment manufacturer is exploring methods to augment filling line technologies that can utilize these innovations in glass packaging to increase the overall capacity and output of fill-finish operations. These technologies coupled together can accelerate the delivery of vaccines and help alleviate the drug shortages caused by production bottlenecks.
[Pivoting From One to Multiple Production Platforms to Treat COVID]
Speaker: Lane Hapke
During the COVID-19 health emergency, the pharmaceutical industry has been challenged to rapidly introduce new medications and/or delivery methods for existing and emerging medications. Ampio Pharmaceuticals has a lead immunomodulatory drug candidate in late-stage development for osteoarthritis of the knee as a 5cc intra-articular injection from sterile single-use vials. This product, Ampion, has demonstrated anti-inflammatory effects, which, when delivered directly to COVID-19 patients may reduce the viral induced cytokine storm and improve clinical outcomes. Ampion development for drug delivery directly to COVID-19 patients via inhalation using sterile vials and via IV systemic application was needed quickly from the existing manufacturing facility. The manufacturing challenge presents itself in the need for new delivery methods of Ampion. This presentation will describe the changes that were made in the manufacturing process, redesigning single-use line sets to accommodate semi-continuously producing drug substance at double the batch size, modifications to the filling process to fill both 10cc vials to support inhalation therapy and 250cc IV bags for direct patient application. The manufacturing facility is now able to support multiple configurations of Ampion drug delivery (injection, IV, inhalation) using modular cleanrooms, minimal fixed equipment, and flexible manufacturing arrangements using single-use closed systems in the original design.