Premier Association Sponsor: PDA
April 25 – 27, 2023
Javits Center, NYC

Stage 1 On-Demand Sessions

Stage 2 On-Demand Sessions

Considering Condensation: Influences in Hydrogen Peroxide Vapor Bio-decontamination

Discussion of the key parameters that influence the condensation point and maximum ppm H2O2 in vaporized hydrogen peroxide applications. We propose four rules that can guide repeatable, effective, bio-decontamination processes. Vaporized hydrogen peroxide (vH2O2) is widely used to perform bio-decontamination in isolators, test chambers, and transfer hatches. Controlling condensation is the most critical component of any bio-decontamination process. -Understanding how process parameters affect condensation also provides insight to the maximum hydrogen peroxide concentration that can be maintained in a vapor state. Humidity level, temperature, and the parts per million (ppm) of vaporized hydrogen peroxide have a combined influence on the condensation point. Once condensation is reached, the ppm vH2O2 cannot be increased.

Democratizing the batch record with Manufacturing Apps

Batch records are the last bastion of paper in pharmaceutical manufacturing and are at the core of regulatory compliance. EBR solutions have been around for the last 2 decades but are highly complex, very expensive, and require significant effort to implement, operate and use.

What if we could digitize batch records in a matter of weeks with a system that process engineers and operators can set up themselves. Adoptions would be rapid and the batch data will be immediately available to operators in digital format. This is the promise of pharmaceutical 4.0, digital tools to rapidly digitize batch information by the people who develop and use the batch records. We call this democratizing the batch record, it is  a core principle of digital transformation. pharmaceutical companies have already adopted this revolutionary approach using a Frontline Operations Platform that is rapidly deployed and is GMP ready.

Cutting edge of aseptic transfer technology in regards of ATMPs and ADCs (mAbs)

The presentation highlights regulatory aspects, e.g. EU-GMP Annex one and will also touch the field of aseptic risk reduction and will show how to increase the quality of sterile drug manufacturing.

Pharmaceutics, Biotech, and Medical Device Automation R&D Tax Credits

The manufacturing industry in the US is at a critical juncture.  More and more companies are pivoting to the medical device, biotechnology. and pharmaceutical manufacturing sectors as opposed to traditional machine shop manufacturing.  The future of US manufacturing is arguably in medical technology (med-tech).  With all the new and improved product development, automation, and innovation to improve health outcomes for our population, come economic benefits, specifically tax benefits.  The Research and Development (R&D) tax credit is one way the federal (and some state governments) award med-tech companies for improving medical devices, prosthetics, automation/processes, etc.  This session will focus on production activities that med-tech companies are already doing that will make them eligible to take R&D tax credits.  This session will identify R&D eligible activities in the med-tech field as well as how to document and claim the R&D tax credit.

E2E Integrated Continuous Bioprocessing

Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting continuous manufacturing platforms for manufacturing biologics (i.e., large proteins or biological products) would in principle be even more justified.  These are very large molecules, complex to produce, with stringent aspects on interchangeability.  Therefore, they present a considerable bigger challenge and have higher criticality in terms of manufacturing sciences and technologies, availability to patients and the regulatory processes involved.  Here we briefly review continuous biomanufacturing (CBM) at a time of very high and global demand for vaccines as well as of increased demand for cell and gene therapy products.

Innovations in Metal and Plastic Micro Welding for Medical Products

Do you have great designs for next generation point of care, drug delivery, monitoring, or surgical products, but need better processes to assemble small interfaces quickly, repeatably, reliably, and economically? During this presentation advanced micro welding processes will be presented for plastic and metallic parts. In all examples, the materials are joined directly and do not require adhesives or fasteners. This assembly simplicity decreases complexity, cost, and weight of the product. These joining processes were recently proven on parts as thin as 0.0005-inch when advanced instrument control and material expertise were applied.

Equipment cleaning considerations during design, start-up, and commissioning of pharmaceutical facilities.

Equipment cleaning concerns are often over-looked during design, startup, and commissioning of pharmaceutical facilities. This is often the case with newer technologies such as mRNA vaccines and cannabis derived products. Failures to link the manufacturing process to cleaning agent selection, physical properties of cleaning chemicals, storage and handling requirements, waste discharge restrictions, dispensing requirements, and material compatibility can lead to costly delays. Technical transfer teams and regulatory agencies expect laboratory testing to support cleaning agent selection, cycle development, quality attributes, and a continuous monitoring strategy. Current industry trends also demand a sustainable cleaning approach which considers water consumption, energy requirements, carry-over concerns of active ingredients, and personnel safety. The presentation will focus on some steps to avoid common pitfalls in designing a new cleaning process through laboratory testing.

Ambitious, Realistic and Business-Friendly: Holistic Approaches to Decarbonization in the Pharmaceutical Industry

The issue of climate protection could not be more urgent and topical. Decarbonization refers to the reduction of carbon, meaning the changeover to an economic system that sustainably reduces CO2 emissions. The pharmaceutical industry is able to make a contribution. This presentation will explore, supported by case studies, the measures that companies in our industry can take to pave the way towards CO2-neutrality. Whether the current policy frameworks are ambitious enough to meet these targets is widely doubted and sustained action is needed. Pharmaceutical companies can play an important role here by investing in the reduction of greenhouse gas emissions. A suitable decarbonization approach reconciles the "bottom-up" perspective, which is based on technically realistic assessments, and the expectations from outside, i.e. a "top-down" view. All relevant areas and business activities are included in a holistic view. A science-based approach makes the strategy reliable for assessment.

Automation of GMP Data Collection - Applied to Cell & Gene Therapy Processes & Equipment Demonstrating Process Control and Compliance

Automated data collection is a key to the commercial launch of any ATMP. Data are needed to demonstrate process control for regulatory application filings, to demonstrate compliance with 21CFR Part 11 Electronic Records/ Electronic Signatures requirements, for process understanding and improvements by MSAT and the integration of production results to MES/EBR systems. Manufacturing Operations need real-time trend data and alarm monitoring of critical equipment – at a glance, and audit trail data from direct impact systems that generate electronic records or signatures. MSAT needs process result data for continuous improvement and process understanding. This result data comes from inherently "closed" systems, that were until recently used in laboratories, were not networked, and removable media was used to manually transfer data. So how to get this data, both real-time and asynchronous, and in various forms to the functional areas that need it, in the right format, place and time?

Industry 4.0 + Pharma: creating smart, flexible, integrated solutions for the future factory

The intersection of digitalization, artificial intelligence, industrial automation, and smart lab technologies promises a brighter tomorrow-one where the pharmaceutical industry can move new therapies from the lab to the patient faster and more efficiently than ever. At the heart of this are smart lab technologies and controls as well as industrial software that help achieve safe and healthy work environments, optimized and interconnected workflows, sustainable and resilient operations, maximum uptime, and flexible processes.