INTERPHEX

Quality and efficiency are long-running—and sometimes conflicting—themes for the manufacture of aseptically processed pharmaceuticals and oral solid dose drugs. The global COVID-19 pandemic brought many existing pharmaceutical manufacturing shortcomings to the forefront. Shortages in materials, capacity, drugs, and limited regulatory oversight highlighted the need for better technologies, processes, and procedures. In this Technology Forum, experts from different segments of the industry assess current challenges and propose solutions to recurring and emerging challenges in aseptic and oral solid-dose drug production.

Pharmaceutical professionals developing drugs for multiple regions

Pharmaceutical professionals developing oral solid dose drugs

Bio/pharmaceutical professionals developing aseptically processed drugs

Regulatory Expectations, Guideline Revisions, and Best Practices in Aseptic Processing

Moderator: Felicity Thomas, European Editor, 

Pharmaceutical Technology, Pharmaceutical Technology Europe,

Despite advancements, aseptic processing remains a challenge for the bio/pharma industry. Regulatory scrutiny of aseptic processes is intense, and associated guidance documents demand strategies that are driven by a quality risk management approach. Both regulatory expectations and recent regulatory revisions are impacting manufacturing operations. Technological advancements designed to improve processes and emerging best practices can help facilities worldwide overcome the pitfalls that plague aseptic processing operations and ensure the cost-effective manufacturing of quality drug products.

Consultants, academic experts, and representatives from industry associations will share recent developments in the following key areas:

Pre-use post sterilization integrity testing (PUPSIT)

Automation and minimizing human interaction with sterile drug products

Evaluating validation practices for advanced manufacturing operations

Advanced Solid-Dosage Drug Manufacturing with Continuous Processing Approaches

Moderator: Jennifer Markarian, Manufacturing Editor, 

Advanced manufacturing strategies, such as continuous manufacturing, have the potential to reduce operating cost and improve quality for oral solid-dosage drugs. Approaches range from individual unit operations running continuously to end-to-end processes. Early adopters have addressed some challenges, and strategies are being adopted for generic drug manufacturing and for reshoring of domestic drug production. Further technology advances, as well as workforce development and consideration of standards and regulatory issues, are underway.

Consultants, academic experts, and representatives from industry associations will share insights on the following topics:

Industry use and development of continuous OSD manufacturing processes

Near- and long-term outlook for continuous manufacturing

Webcasts

Wednesday, September 15, 2021 at 10am EDTDrug manufacturing demands and increased regulatory oversight are prompting pharmaceutical manufacturers to consider new processes for oral solid dose and aseptically processed drugs. A cross-section of industry experts will offer insight on emerging trends, technologies, and processes in this Technology Forum. 

Technology Forum: The Next Steps for Pharma Manufacturing Efficiency and Effectiveness 

https://www.pharmtech.com/pt_w/interphex2

The bio/pharma industry is turning to proven digital technologies used in other industries to plan, develop, and monitor manufacturing processes, as well as in quality, training, and regulatory oversight. In this event, experts discuss how artificial intelligence, remote monitoring, digital twins, and other technologies can be applied to modernize bio/pharma processes and systems. Lessons learned from the pandemic will be shared.

Digitalization: Moving from Theory to Practice

The use of digital technologies for bio/pharmaceutical process development, manufacturing, quality control, and general operations sounds promising. What are the challenges in putting these innovations into practice in a regulated environment? Experts will share insights and experience in moving digital concepts into practice.

What bio/pharma can learn from practices in other industries

Improving product quality with digital tools for the lab and manufacturing facility

The role of AI, analytics, and digital twins in the facility of the future

Remote auditing pitfalls and best practices

Using virtual inspection tools for evaluating vendors and manufacturing facilities

Evgeniya Makarova, partner, McKinsey & Company

Ulf Schrader, senior partner, McKinsey & Company

Peter Miller, principal partner, Dynamic Compliance Solutions

Chris Alden, associate director, global CGMP auditing and compliance, Merck

Harnessing Digitalization Technologies in Pharma Manufacturing

Pharmaceutical manufacturers are moving towards digital maturity, enabled by increasing levels of connectivity and availability of digital technologies tailored for the pharmaceutical industry. Digitalization benefits process design and development, as well as operations. Hear experts discuss current trends, benefits and challenges of adopting Pharma 4.0 technologies, and lessons to be learned from other industries for all areas of pharmaceutical manufacturing.

Hear expert insight on key pharmaceutical process development and manufacturing topics:

Digital tools for facility and process design

Simulation and digital twins for scaleup and tech transfer

Yvonne Duckworth, PE, registered automation engineer, CRB

Harbinder Pordal, principal consultant, Stress Engineering


On demand available after final airing until May 25, 2022

*Tuesday, May 25, 2021 at 10am EDT* The bio/pharma industry is turning to proven digital technologies used in other industries to plan, develop, and monitor manufacturing processes, as well as in quality, training, and regulatory oversight. In this event, experts discuss how artificial intelligence, remote monitoring, digital twins, and other technologies can be applied to modernize bio/pharma processes and systems. Lessons learned from the pandemic will be shared. *On Demand Until May 25, 2022*

Bridging the Digital Divide to Advance Bio/Pharma Manufacturing and Quality: A Technology Forum 

A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.

The COVID-19 pandemic quickly brought supply chain and manufacturing deficiencies to light. The rapid deployment of select science- and technology-based solutions temporarily filled in productivity, communication, and supply chain gaps.

In this Technology Forum, the editors of Pharmaceutical Technology and BioPharm International share insight from process, manufacturing, and supply chain experts on promising and proven methods to ensure drug production continuity for small-molecule and biologic drugs.

Reinventing Small-Molecule Drug Process Development and Manufacturing

The COVID-19 pandemic and nitrosamines contamination emergency exposed vulnerabilities in the small-molecule drug manufacturing and supply chain. Efforts to enhance continuous manufacturing processes, new technologies for process intensification, and investment in drug manufacturing infrastructure are showing promising results. Hear experts discuss current trends, and how technology and process improvements can advance the development, manufacturing, and distribution of generic and innovator small-molecule drug.

Development and Manufacturing Strategies to Meet Biologic Drug Demand

Manufacturing capacity for biologic drugs, as well as fill-finish operations has been strained in the past year by demand for vaccines and therapies to combat COVID-19. Hear expert insight on how the bio/pharma industry is responding to the demand for materials, equipment, and manufacturing.

Understand strategies to for more efficient and effective small-molecule drug manufacturing

Review regulatory implications of the pandemic and strategies to comply with GMPs

Learn how demand for vaccines is impacting biologics drug manufacturing capacity, and ways to avoid roadblocks.

Session 1: Thursday, April 22, 2021, 10am EDT

Session 2: Thursday, April 22, 2021, 11am EDT

Session 3: Thursday, April 22, 2021, 1pm EDT

: Lonza, Emergent, Thermo Fisher Scientific, ILC Dover, Bora Pharmaceuticals, Patheon  

***Session 1: Thursday, April 22, 2021, 10am EDT, Session 2: Thursday, April 22, 2021, 11am EDT, Session 3: Thursday, April 22, 2021, 1pm EDT***  A drug’s journey from development to manufacturing to patients is paved with roadblocks and potholes; many threats can derail bio/pharmaceutical processes. Potential solutions to such pitfalls have been discussed for years; however, few manufacturers have embraced technology and process advances to proactively ensure drug supply chain continuity.  


Technology Forum Series: Strategies to Prevent Drug Shortages and Resolve Capacity Challenges.

http://promo.mjhlifesciences.com/biopharmacongress/

The COVID-19 pandemic has disrupted the routine of in-person events, the need for sharing information and building key supplier connections for bio/pharmaceutical development and manufacturing has never been greater.

The 2020 Bio/Pharma Virtual Congress event will connect bio/pharma formulation, development, manufacturing, and quality experts with a full day of technical presentations, panel discussions, interviews, and vendor meetings, through an interactive portal.

This online event will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry.

Adare, Aizon, BASF, Beckman Coulter, Catalent, DocuSign, Honeywell, Lighthouse, Lonza Pharma and Biotech, LSNE, Mikart, Nelson Labs, Qualicaps, Shimadzu, suez and VAI

Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT

On demand available after airing until Nov. 11, 2021.

*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021

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