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  • Opening Ceremony

    03/21/2017, 9:25 AM - 9:35 AM, Main Entrance

    Come celebrate the start of the show!

    • Language: English

  • Passport Program

    03/21/2017, 10:00 AM - 12:00 PM, Exhibit Hall

    Receive your passport at Registration or the Information Desks and visit all participating sponsors at their booths to get your passport stamped. Once you’ve co...

    • Language: English

  • Realizing Benefits and Efficiencies from Quality Systems

    03/21/2017, 10:15 AM - 11:00 AM, INTERPHEX Live, Crystal Palace CP-2

    Aaron Weinstein, IPS-Integrated Project Services Jeff Meltzer, VP, Quality Management, Trevena

    • Language: English

  • Serialization and Tracebility: Final Agenda: There's Still Time: Accelerated Compliance Programs

    03/21/2017, 10:30 AM - 12:50 PM, INTERPHEX Innovation Stage

    Even though the deadline for serialization compliance is only a few months away, a number of companies not have developed serialization strategies and finalized...

    • Language: English

  • Beyond Fill & Finish: How Market Demands and Regulatory Requirements are Expanding Deliverables of Traditional Sterile Fillers

    03/21/2017, 10:30 AM - 11:00 AM, Meeting Room 5

    Catalent, an expert in sterile fill finish, continues to expand its offerings to meet the needs of a changing market – most recently with the expansion of its s...

    • Language: English

  • Serialization and Traceability: Final Agenda: Future Trends: Blockchain in the Pharma Supply Chain - Why the Pharma/Biopharma Industry Needs Blockchain

    03/21/2017, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

    Advanced Digital Ledger Technology™ (ADLT™) has the potential to alter the flow of information within and between trusted partners in the biopharma industry. A...

    • Language: English

  • Serialization and Traceability: Final Agenda: Outsourcing and Serialization/Traceability - How Prepared is Your Contract Service Provider?

    03/21/2017, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

    Approximately one-third of contract manufacturers have any plans or meaningful ability to prepare for the impending DSCSA serialization deadline in November. Wh...

    • Language: English

  • Serialization and Traceability: Final Agenda: Real-world serialization: results of a pilot involving a major distributor

    03/21/2017, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

    Legislation is transforming the pharmaceutical supply chain to improve patient safety by requiring traceability of prescription drugs. End-to-end thinking is ne...

    • Language: English

  • Processes and factory of the future. Single use and flexible for faster, cheaper and safer manufacturing

    03/21/2017, 10:30 AM - 11:15 AM, Meeting Room 2

    Despite the introduction of new technologies, the majority of Biotech processes and facilities still contain a number of stainless steel and multi-use equipment...

    • Language: English

  • Particle Size Measurement in Twin Screw Wet Granulation; An Analysis of the Value of In-Line and At-Line Measurement Data

    03/21/2017, 10:30 AM - 11:15 AM, Meeting Room 3

    This presentation examines the data collected from both in-line and at-line measurement methods during the execution of a DOE aimed at quantifying, using a data...

    • Language: English

  • Is it true, the European GMP Annex 1 revision will have no adverse impact on resources or costs while supporting new technology implementation?

    03/21/2017, 10:30 AM - 11:15 AM, Meeting Room 4

    The presentation goal is to answer the question (asked in the title) by deep diving into the impact on each revision proposed by several entities. The presentat...

    • Language: English

  • Developing and Transferring Remote Swab TOC Method

    03/21/2017, 10:30 AM - 11:15 AM, Meeting Room 1

    A cleaning program is designed to provide assurance that process related residues and cleaning agents are reduced to an acceptable level after cleaning. During ...

    • Language: English

  • Evolution of Pre-filled Syringes

    03/21/2017, 11:15 AM - 12:00 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • The Three Faces of Validation

    03/21/2017, 11:30 AM - 12:00 PM, Meeting Room 5

    "This workshop panel discusses the three perspectives (bioprocessing company, system integrator, component manufacturer) of validation methodology for single-us...

    • Language: English

  • Managing Process Scale-up and Tech Transfer

    03/21/2017, 11:30 AM - 12:15 PM, Meeting Room 4

    According to ICH Q10, "The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within...

    • Language: English

  • Disposable Liquid Filling for Sterile Products

    03/21/2017, 11:30 AM - 12:15 PM, Meeting Room 2

    Disposable Liquid filling provides advantages beyond conventional methods used in the pharmaceutical and medical device industry. It minimizes contamination du...

    • Language: English

  • Cleaning air-liquid interface residues

    03/21/2017, 11:30 AM - 12:15 PM, Meeting Room 3

    Good manufacturing practices (GMP) regulated industries continue to struggle with visible residue at the air-liquid interface. Air-liquid interface residue may...

    • Language: English

  • Buffer Make-up Comparison: Continuous Inline versus Cycling Batch

    03/21/2017, 11:30 AM - 12:15 PM, Meeting Room 1

    Column Chromatography is frequently used to purify proteins. Large volumes of buffers are required to operate chromatography columns continuously. Oftentimes, b...

    • Language: English

  • Smart Manufacturing Enabled by the Connected Enterprise

    03/21/2017, 1:00 PM - 1:30 PM, Meeting Room 5

    Life Science companies face significant challenges to increase operational efficiency, reduce costs, increase quality and manage risk, while improving flexibili...

    • Language: English

  • Implementing Continuous Manufacturing for Solid-Dosage Drugs:Different Approaches to Continuous Manufacturing within the Pharmaceutical Industry

    03/21/2017, 1:30 PM - 3:00 PM, INTERPHEX Innovation Stage

    The pharmaceutical industry is in the process of modernizing its manufacturing practices. Companies are replacing outdated batch unit operations with more innov...

    • Language: English

  • Implementing Continuous Manufacturing for Solid-Dosage Drugs: Automating Continuous Manufacturing

    03/21/2017, 1:30 PM - 3:00 PM, INTERPHEX Innovation Stage

    More companies are making the move towards continuous manufacturing. Smart data solutions must be provided to streamline the dataflow and get the essential info...

    • Language: English

  • Implementing Continuous Manufacturing for Solid-Dosage Drugs: Advancing Continuous Solid-Dosage Manufacturing

    03/21/2017, 1:30 PM - 3:00 PM, INTERPHEX Innovation Stage

    Over the course of the past decade the foundations for today's continuous pharmaceutical manufacturing have been developed through public private partnerships l...

    • Language: English

  • Sporeformers & Biocontainment: Designing to Mitigate Risk and Avoid “Threat Level Midnight”

    03/21/2017, 1:30 PM - 2:15 PM, Meeting Room 2

    Biomanufacturing spaces containing spore forming microorganism must be carefully designed, tightly controlled and constantly monitored to mitigate the risk of s...

    • Language: English

  • The "Real" Path to Real Time Release of Total Organic Carbon and Conductivity

    03/21/2017, 1:30 PM - 2:15 PM, Meeting Room 3

    Purified Water (PW) and Water for Injection (WFI) are common raw materials in pharmaceutical and bio-pharmaceutical manufacturing. The quality of these waters i...

    • Language: English

  • Hybrid Facilities - an economical evaluation between single use and reusable process equipment

    03/21/2017, 1:30 PM - 2:15 PM, Meeting Room 4

    As single use systems and flexible facilities become more prevalent in industry, and new biopharmaceutical products are introduced, there is often considerable ...

    • Language: English

  • How scientific companies use the Talent Supply Chain Management model to link human capital to business needs to increase productivity and efficiency

    03/21/2017, 1:30 PM - 2:15 PM, Meeting Room 1

    Just like the conventional supply chain management, talent supply chain management model (TSCM) is an adaptable process of mobilizing and engaging resources on ...

    • Language: English

  • Capsules: The Go-To Dosage Form

    03/21/2017, 1:30 PM - 2:15 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Shaping the Future of Theraputics: New Workflow Innovations for Drug Discovery, Development and Manufacturing

    03/21/2017, 2:00 PM - 2:30 PM, Meeting Room 5

    "• Brief overview of Bio-Rad "A global trusted partner supporting pharma and biotech" • Case studies describing how new innovative products in cell biology and...

    • Language: English

  • cGMP Clean Space: Innovative Solutions for Compliant and Cost-Effective Facilities

    03/21/2017, 2:15 PM - 3:00 PM, INTERPHEX Live, Crystal Palace CP-2

    Smart manufacturers are taking a second look at the legacy assumptions and rules of thumb that characterized cleanroom design in the past. Rising costs and spa...

    • Language: English

  • Stress Testing, Mitigating Risks and Remediation: How to Maintain a Fit Facility

    03/21/2017, 2:30 PM - 3:15 PM, Meeting Room 2

    Biopharmaceutical manufacturing processes must consistently yield high quality products that are safe for consumers. To do so, facility and process equipment mu...

    • Language: English

  • Scale-up of high area filters for microfiltration of biological fluids - points to consider for reliable scale-up

    03/21/2017, 2:30 PM - 3:15 PM, Meeting Room 1

    Sterilizing grade membrane filters are often packaged in pleated formats. A wide variety of pleat configurations are possible including high density pleat geom...

    • Language: English

  • Integrated Continuous Manufacturing Progress and the Life Science Industry "Fad or Reality?"

    03/21/2017, 2:30 PM - 3:15 PM, Meeting Room 4

    The importance of Integrated Continuous Manufacturing (ICM): economic, sustainability advantages and modular nature of ICM, and the industry is able to adapt mo...

    • Language: English

  • Designing Flexibility into Oligonucleotide Manufacturing Facilities Through Process and Product Understanding

    03/21/2017, 2:30 PM - 3:15 PM, Meeting Room 3

    Oligos fit neither small or large molecule paradigms, and should not be constrained to templated approaches based on either of these models. The upstream proces...

    • Language: English

  • The Next Generation of Sporicidal Disinfectant

    03/21/2017, 3:00 PM - 3:30 PM, Meeting Room 5

    Peridox is the next generation sporicidal disinfectant with its broad kill claims, short contact times and cleaning ability, Peridox offers pharmaceutical manuf...

    • Language: English

  • Fortem: Challenges and opportunities in developing a new plastic film for bioprocess activities.

    03/21/2017, 3:00 PM - 3:45 PM, INTERPHEX Live, Crystal Palace CP-2

    Fortem: Challenges and opportunities i developiong a new plastric film for bioporcess activites.

    • Language: English

  • Secure, Fast and Reliable Data Transfer: A Competitive Differentiator in the World of Genomic Sequencing

    03/21/2017, 3:30 PM - 4:15 PM, INTERPHEX Innovation Stage

    In the race to find breakthrough cures and treatments, equipment in the lab gets a lot of attention, but when achieving speed, accuracy and security of data tra...

    • Language: English

  • The Future of Oligonucleotides

    03/21/2017, 3:30 PM - 4:15 PM, Meeting Room 2

    It is exciting to track the changes in the production of oligonucleotide therapies. An oligonucleotide is a strand of RNA that is used to hi-jack the genes' mes...

    • Language: English

  • Time is of the essence: Creating a new synergy between single-use adopters and suppliers

    03/21/2017, 3:30 PM - 4:15 PM, Meeting Room 4

    Biopharmaceutical companies race to achieve milestones, advance promising molecules, improve productivity and reduce costs. In addition to perfecting the biolog...

    • Language: English

  • Tablet Press & Capsule Filling Machine Transaction Regulations

    03/21/2017, 3:30 PM - 4:15 PM, Meeting Room 3

    New federal regulations on mandatory electronic reporting of transactions for tableting and encapsulating machines will be presented. All machines are covered; ...

    • Language: English

  • So Many Solvents, So Little Time making sense of industry and regulatory guidance on model solvents for extractables studies on single

    03/21/2017, 3:30 PM - 4:15 PM, Meeting Room 1

    Numerous trade associations have published recommendations on extraction methods and analytical technique to identify and quantify extractables from single use ...

    • Language: English

  • The Future of Flexible Manufacturing

    03/21/2017, 3:45 PM - 4:30 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Process Control with the Use of PAT; ControLyo™ and TDLAS in Commercial Manufacturing

    03/21/2017, 4:00 PM - 4:30 PM, Meeting Room 5

    This session will cover key aspects of process which will have significant impact on product quality attributes and how to control and monitor the process using...

    • Language: English

  • Utilization of Supercritical Fluid Processing for Purification, Dissolution and Infiltration

    03/21/2017, 4:15 PM - 5:00 PM, Meeting Room 1

    The Supercritical Fluid Process has been used in production for purification of organic materials for pharmaceutical and nutraceutical applications . Significan...

    • Language: English

  • Taking Virtual Reality to Reality

    03/21/2017, 4:15 PM - 5:00 PM, Meeting Room 2

    Many companies developing virtual drugs and have limited access to actual laboratories or research and development faciltites. The next step in testing these dr...

    • Language: English

  • New Data and modeling of Continuous Countercurrent Tangential Chromatography (CCTC) platform for capture, ion exchange and mixed mode chromatography

    03/21/2017, 4:15 PM - 5:00 PM, Meeting Room 3

    Chromatan's CCTC is a new column-free continuous purification platform for mAbs, vaccines and other biologics, providing a scalable and disposable alternative t...

    • Language: English

  • Improving API yield with new revolutionary particle agglomeration-enhancing cyclone geometries

    03/21/2017, 4:15 PM - 5:00 PM, Meeting Room 4

    Reverse flow cyclones are gas-solid separation devices with low investment and operation costs but with difficulty capturing fine and low-density API particles,...

    • Language: English

  • Show Wrap Up Day 1

    03/21/2017, 4:30 PM - 4:45 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Test Session

    03/22/2017, 9:00 AM - 5:00 PM, Test

    Test

    • Language: English

  • DSCSA: New Regulations Require Action

    03/22/2017, 10:15 AM - 11:00 AM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Best Practices in Equipment Cleaning & Cleaning Validation: Use of Statistical Tools in Cleaning Validation Lifecycle

    03/22/2017, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

    Presentation “Use of Statistics in Cleaning Validation Lifecycle” proposes a number of statistical tools that help in evaluation of data attained in three stage...

    • Language: English

  • Best Practices in Equipment Cleaning & Cleaning Validation: Cleaning Limits & Visual Inspection from an Analytical Perspective

    03/22/2017, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

      Visual inspection following equipment cleaning is a mandatory step in the cleaning verification workflow for pharmaceutical equipment. Equipment must pass vis...

    • Language: English

  • Smart Manufacturing Enabled by the Connected Enterprise

    03/22/2017, 10:30 AM - 11:00 AM, Meeting Room 5

    Life Science companies face significant challenges to increase operational efficiency, reduce costs, increase quality and manage risk, while improving flexibili...

    • Language: English

  • Best Practices in Equipment Cleaning and Cleaning Validation: A New ASTM Standard for Cleaning Validation

    03/22/2017, 10:30 AM - 12:30 PM, INTERPHEX Innovation Stage

      This presentation will introduce the“Standard Guide for Science and Risk-based Cleaning Process Development and Validation” a standard guide in the final stag...

    • Language: English

  • Biosafety Considerations for Single Use Technology

    03/22/2017, 10:30 AM - 11:15 AM, Meeting Room 2

    Biosafety Considerations for Single Use Technology

    • Language: English

  • Multi-point Battery-free Wireless Sensors for Aseptic Process Monitoring

    03/22/2017, 10:30 AM - 11:15 AM, Meeting Room 4

    Monitoring product temperature accurately is critical to process development and scale-up related work in the pharma/bio-pharmaceutical industry. Ability to con...

    • Language: English

  • Ensuring Data Integrity Through Quality Systems and Auditing Techniques

    03/22/2017, 10:30 AM - 11:15 AM, Meeting Room 3

    Data integrity is not a new concept, but due to recent FDA Warning Letters and other global compliance actions, it has garnered much focus and needed attention....

    • Language: English

  • DME Facilty Focus: cGMP Facility Modernization: New Solutions for Aging Facilities

    03/22/2017, 10:30 AM - 11:30 AM, Meeting Room 1

    In recent years, disruptive technologies have created a new vision for the cGMP facility of the future- one that offers the promise of improved manufacturing fl...

    • Language: English

  • Regulatory Aspects of Continuous BioProcessing

    03/22/2017, 11:15 AM - 12:00 PM, INTERPHEX Live, Crystal Palace CP-2

    • Language: English

  • Serialization Journey

    03/22/2017, 11:30 AM - 12:15 PM, Meeting Room 2

    TBA

    • Language: English

  • Serialization Best Practices for CMO Onboarding

    03/22/2017, 11:30 AM - 12:00 PM, Meeting Room 5

    This session will discuss serialization best practices and processes to optimize the success of your CMO onboarding plan.

    • Language: English

  • Introduction to end-to-end solution from formulation to final filling in pharmaceutical environment: How to speed up and to facilitate the process of liquid sterile drug products using single-use technologies.

    03/22/2017, 11:30 AM - 12:15 PM, Meeting Room 4

    Formulation of drug products is mainly driven by mixing operations, they can be facilitated and optimized with the automation of components addition and the con...

    • Language: English

  • Intricacies of Shipping High Value, ultra-sensitive Pharmaceutical Processing Equipment: Avoiding pitfalls in the final presentation

    03/22/2017, 11:30 AM - 12:15 PM, Meeting Room 3

    There is a need for quality material devoted to standardized procedures to minimize in-transit damage and litigation for high-value processing equipment. It is...

    • Language: English

  • Strategies for the Coating of Multiparticulates Utilizing the Conical Rotor Processor

    03/22/2017, 1:00 PM - 1:30 PM, Meeting Room 5

    This session will discuss the benefits of using the conical rotor processor for processing multiparticulates. There will be a focus on dry powder layering, incl...

    • Language: English

  • DME Facility Focus: Next Generation Aseptic Manufacturing: An Eye-opening Peek into The Future

    03/22/2017, 1:00 PM - 2:00 PM, Meeting Room 1

    Sterile product manufacturers are presented with a complex array of technology and compliance challenges: Legacy Facilities, Isolator Decontamination; Single-Us...

    • Language: English

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