- Insight on Upcoming Changes in Serialization Implementation, Automating Continuous Manufacturing,
Cleaning Validation Guidance and Regulatory Roadblocks Awaiting Attendees-
NEW YORK, NY; February 16, 2017 – International Pharmaceutical Expo (INTERPHEX), the premier event dedicated to pharmaceutical, biotechnology and device innovation, technology and knowledge from development through commercialization, and Pharmaceutical Technology and BioPharm International, two leading information sources for the global drug development and manufacturing community, today released the Keynote Series program for 2017. INTERPHEX takes place March 21-23, 2017 at the Javits Center in New York, New York.
Tuesday, March 21, 10:30am –12:30pm - “Serialization and Traceability: The Final Countdown”
As the deadline for serialization implementation in the US approaches, most, but not all, bio/pharma companies and contract pharmaceutical manufacturers have developed strategies for compliance. Speakers look at the current state of implementation, as well as industry best practices, recent results of pilot tests and research, and discuss a new program designed to help accelerate progress for companies that have not yet addressed the new requirements.
- “Moving from Compliance to Value: A State of the Industry Report”
What progress have pharmaceutical manufacturers and their supply chain partners made in implementing traceability initiatives? In these final months before the Drug Supply Chain Security Act implementation deadline, what technical and cultural issues remain? This session examines the results of an extensive industry survey and focuses on areas where serialization and traceability projects can bring significant business value.
- “Accelerating Compliance in the Final Stretch”
Even though the deadline for serialization compliance is only months away, not all companies not have developed serialization strategies and finalized technical initiatives. Speakers discuss a new program, based on open standards and basic data communication templates, that aims to get companies up and running in time to meet the deadline.
- “BlockChain as a Supply Chain Tool”
What is blockchain and how could it help boost supply chain security? Speakers provide an overview of the technology, and discuss results of research into the use of blockchain within the pharma industry.
Tuesday, March 21, 1:30pm–3:00pm - “Implementing Continuous Manufacturing for Solid-Dosage Drugs”
Continuous manufacturing for solid-dosage offers potential for greater flexibility, efficiency, and quality. Early adopters now have regulatory approval for drugs made with continuous processes. Equipment and process analytical technology for continuous tablet production are available. This session looks at available technologies and the challenges that remain.
- “Different Approaches to Continuous Manufacturing Within the Pharmaceutical Industry”
Companies are replacing outdated batch unit operations with more innovative, efficient, and automated continuous processes. Different approaches are being utilized, from targeted solutions to integrated end-to-end strategies, each with its own risks and benefits. There are many drivers for this transformation, including pressure to reduce drug costs and more stringent quality requirements imposed by regulators. This presentation examines the different tactics companies are employing and their respective advantages, with a focus on small-molecule drugs.
- “Automating Continuous Manufacturing”
As companies move toward continuous manufacturing, smart data solutions must be provided to streamline the dataflow and get the essential information out of the big data stream. This presentation dives into the mechanism of continuous manufacturing, leaving the isolated ‘islands of automation’ and working towards a fully integrated approach. Real, established use cases will demonstrate how a process analytical technology (PAT) approach can be established in a continuous manufacturing area.
- “Advancing Continuous Solid-Dosage Manufacturing”
Over the course of the past decade the foundations for today's continuous pharmaceutical manufacturing have been developed through public private partnerships like C-SOPS. This is particularly true in the case of solid dose. Today, as the interest in transitioning to this new means of manufacturing continues to grow, we continue to develop new
ways to better enable technological adoption. Here, presentations include newest innovations for faster development of products using less material along with programmatic activities aimed at easing the regulatory pathway.
Wednesday, March 22, 10:30am–12:30pm - “Best Practices in Equipment Cleaning and Cleaning Validation”
Efforts are underway to bring more scientifically-based standards to cleaning validation. Speakers will discuss new developments, and various areas of focus in a dynamic subject.
- “A New ASTM Standard for Cleaning Validation”
Guidelines previously published by ISPE and under development for the past five years are now being combined in a “Standard Guide for Science and Risk-based Cleaning Process Development and Validation,” a standard now under development by the American Society for Testing and Materials (ASTM).
- “Training for Qualification”
Successful cleaning validation is critical to patient safety. This presentation examines PDE and ADE cleaning limits, and what is needed for qualification for visual inspection.
Wednesday, March 22, 1:30pm–3:00pm - “Post-Approval Changes: Addressing Regulatory Roadblocks”
Changes to a manufacturing process during the lifecycle of a drug product are inevitable. New regulations, materials suppliers, and facility and equipment updates can contribute to improved processes. The complications and costs of implementing these changes, particularly in a global environment, may discourage companies from updating facilities and systems, contributing to a downward quality spiral. This session will examine ongoing challenges with implementing post-approval changes, efforts to educate and harmonize national and regional regulations, and will feature an approach to address post-approval changes during the initial application process.
- “PDA‘s Task Force on Post Approval Change Innovation for Availability of Medicines Program”
PDA’s Task Forces of Drug Shortage and Aging Facilities showed that the current complexity of Post Approval Changes is a major contributor to the hesitancy to implement new technologies and/or update processes and facilities. If such process and facilities are not updated, break-down, quality excursions or obsolescence can occur, which respectively may result in shortage of product supplies. Reviews, workshops and surveys performed by PDA showed that a major contribution for failing processes and/or facilities are post approval change timelines and regulatory burdens. PDA has formed a task force to address these issues and recommend approaches how post approval changes may be address in a faster and efficient way. The presentation discusses the findings and additional steps to be taken.
- “Japan Common Technical Document: Bracketing Strategies for the Manufacturing Process”
Pharmaceutical companies filing drug applications for the Japanese market must submit bracketing strategies for aspects of the manufacturing process including process parameters, quality attributes, operating and storage conditions, type and concentration of materials used, and proposals for handling post-approval changes. This is typically done by enclosing critical and non-critical aspects of the manufacturing process in major and minor brackets. Any post-approval changes require appropriate regulatory action. Each bracketing strategy offers advantages and limitations, and determines whether a manufacturing deviation is allowed and whether a pre-approval for implementation of a post-approval change is required. Aspects related to bracketing strategies will be discussed.
To register for INTERPHEX 2017, visit http://www.interphex.com/en/Register.
About Pharmaceutical Technology and BioPharm International
Pharmaceutical Technology is the authoritative source of peer-reviewed research and expert analyses for scientists, engineers, and managers engaged in process development, manufacturing, formulation and drug delivery, API synthesis, analytical technology and testing, packaging, IT, outsourcing, and regulatory compliance in the pharmaceutical and biopharmaceutical industries. BioPharm International integrates the science and business of biopharmaceutical research, development, and manufacturing through peer-reviewed papers and practical insight and research. Pharmaceutical Technology and BioPharm International are part of the UBM Life Sciences unit of UBM Americas, a US-based event, information, and marketing services business serving professional communities in human healthcare, veterinary medicine, and the pharmaceutical industry with an unmatched portfolio of in-person, print, and digital products. The brands includes Pharmaceutical Technology, Pharmaceutical Technology Europe, www.PharmTech.com, BioPharm International, and wwwbiopharminternational.com
For the past 38 years, INTERPHEX has been, and continues to be, the premier pharmaceutical, biotechnology, and device development and manufacturing event where you can “Experience Science through Commercialization.” Sponsored by the Parenteral Drug Association (PDA), the event is based in New York and brings over 11,500 global industry professionals and 625+ industry leading suppliers together to “Learn it, Experience it, Procure it” through a unique combination of no cost technical conference, exhibits, demonstrations, workshops, partnering opportunities and networking to leverage quality, efficiency and cost effectiveness in today’s ever-changing global market. INTERPHEX offers annual domestic and international industry events and educational opportunities around the world. Follow INTERPHEX on Facebook, LinkedIn, Instagram, YouTube, and Twitter. IPX Blog continues the learning beyond the show floor. For more information, visit www.INTERPHEX.com.