• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 25
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 25
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    Hygienic Packaging Technology

    Trends in Solid Oral Dosage Delivery

    5 Reasons Paper Has No Place in Contract Manufacturing

    Injectable Drug Delivery Trends

    Pharmaceutical Manufacturing Equipment Trends
    Breaking News
    Online Exclusives
    Industry News
    Collaborations & Alliances
    Promotions & Moves
    Trials & Filings
    Financial Reports
    Bio News & Views
    Custom Sourcing News
    Packaging & Tracking
    CRO News
    Live From Shows
    Top News
    AGC Biologics Expands Cell and Gene Facility in Italy

    Celonic to Boost Cell & Gene Therapy Production

    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie

    Aptamer Extends Collaboration with AstraZeneca

    Fujifilm Breaks Ground on Major Expansion of Biologics Facility in Denmark
    APIs
    Aseptic Processing
    Cleaning Validation
    Clinical Trial Materials
    Cytotoxics and High Potency Manufacturing
    Equipment
    Excipients
    Extractables and Leachables
    Facilities
    Fill/Finish
    Lyophilization
    Parenterals
    Process Development
    Process Validation
    Risk Management
    Scale-up/ Technology Transfer
    Solid Dosage/ Creams/ Ointments

    AGC Biologics Expands Cell and Gene Facility in Italy

    Celonic to Boost Cell & Gene Therapy Production

    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie

    Fujifilm Breaks Ground on Major Expansion of Biologics Facility in Denmark

    Reed-Lane Facility Virtual Tour
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Reed-Lane Facility Virtual Tour

    Hygienic Packaging Technology

    Reshaping the Pharmaceutical Supply Chain

    Serialization: Level 5 Solution

    Covectra Introduces Next-Gen Serialization Solution
    Analytical Services
    Bioanalytical Services
    Bioassay Developement
    Biologics, Proteins, Vaccines
    Biosimilars
    Chemistry
    Clinical Trials
    Drug Delivery
    Drug Development
    Drug Discovery
    Formulation Development
    Information Technology
    Laboratory Testing
    Methods Development
    Microbiology
    Preclinical Outsourcing
    R&D
    Toxicology

    Data Management Trends

    AGC Biologics Expands Cell and Gene Facility in Italy

    Celonic to Boost Cell & Gene Therapy Production

    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie

    Aptamer Extends Collaboration with AstraZeneca
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Guide to Maintaining Validation of Older Facilities: Why, When and How

    The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    Gene Therapy Co. Selects ValGenesis' SaaS Platform
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Adare Pharma Solutions

    Syngene

    Reed-Lane

    Emergent BioSolutions

    PCI Pharma Services
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Cytovance Biologics

    Almac Group

    Alcami

    Reed-Lane

    Syngene
    Webinars
    Live From Shows
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
      • Enewsletter Archive
      • Digital Edition
    • Directory
      • Companies
      • Categories
      • Corporate Capabilities
      • Add Your Company
    • Manufacturing
      • APIs
      • Aseptic Processing
      • Cleaning Validation
      • Clinical Trial Materials
      • Cytotoxics and High Potency Manufacturing
      • Equipment
      • Excipients
      • Extractables and Leachables
      • Facilities
      • Fill/Finish
      • Lyophilization
      • Parenterals
      • Process Development
      • Process Validation
      • Risk Management
      • Scale-up/ Technology Transfer
      • Solid Dosage/ Creams/ Ointments
      • cGMP Manufacture
    • Packaging
      • Capsules
      • Cold Chain Management
      • Injectables
      • Logistics
      • Serialization
      • Solid Dosage / Semi-solids
      • Supply Chain
      • Vials
    • Development
      • Analytical Services
      • Bioanalytical Services
      • Bioassay Developement
      • Biologics, Proteins, Vaccines
      • Biosimilars
      • Chemistry
      • Clinical Trials
      • Drug Delivery
      • Drug Development
      • Drug Discovery
      • Formulation Development
      • Information Technology
      • Laboratory Testing
      • Methods Development
      • Microbiology
      • Preclinical Outsourcing
      • R&D
      • Toxicology
    • Compliance
      • Filtration & Purification
      • GMPs/GCPs
      • Inspections
      • QA/QC
      • Regulatory Affairs
      • Validation
    • Top 25 Pharma & BioPharma
    • Contract Pharma Direct
    • Breaking News
    • Online Exclusives
    • Slideshows
    • Experts Opinions
    • Surveys
      • Outsourcing Survey
      • Salary Survey
    • Glossary
    • Videos
    • Podcasts
    • White Papers
    • Infographics
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • eBook
    • Webinars
    • Events
      • Industry Events
      • Live from Show Events
      • Webinars
    • Classifieds / Job Bank
      • Classifieds
      • Job Bank
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Online Exclusives

    Primary Packaging Considerations Amid COVID-19 Vax Urgency

    Fran L. DeGrazio of West discusses why and how vaccine development is different than drug development and the impacts of COVID-19 on vaccine development.

    Primary Packaging Considerations Amid COVID-19 Vax Urgency
    Related CONTENT
    • Reshaping the Pharmaceutical Supply Chain
    • J&J’s Single-Dose COVID-19 Vax Issued EUA
    • AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
    • Pfizer, BioNTech To Supply 200M More Vax Doses to EU
    • Novavax, SK Bioscience Expand Vax Pact
    Kristin Brooks, Contract Pharma10.05.20

    Vaccine development differs widely from drug development in many ways, including packaging, storage and distribution. Primary packaging plays a critical role in the stability of vaccines and COVID-19 has created an urgency that disrupts standard evaluation of potential packaging systems.

    Fran L. DeGrazio, Chief Scientific Officer at West Pharmaceutical Services discusses why and how vaccine development is different than drug development, and the nuances of vaccine development in the current landscape regarding COVID-19. –KB  

    Contract Pharma: How does vaccine development differ from drug development? What key distinctions does vaccine development entail?

    Fran L. DeGrazio: While overlap exists across certain elements critical to the development process for vaccines and drugs, many key nuances differ between the two. Vaccines in general tend to be more temperature-sensitive, for example, which triggers the need to maintain a secure “cold chain” during storage, handling, and transportation.

    Further, the pure scale of vaccine development and production is significantly larger than that of a single new drug – from the number of involved resources to the number of units produced, storage needs, access and beyond.

    CP: How is the current landscape regarding COVID-19 impacting vaccine development?

    FD: Development and distribution of a vaccine for SARS-CoV-2 presents challenges that are wholly unprecedented and impact the industry at large, as all players – from contract manufacturers to pharmaceutical and biotech companies to clinicians/scientists – must adapt accordingly in order to deliver a safe and effective vaccine as quickly as possible.

    First and foremost, there is an unparalleled sense of urgency, given the impact to-date and potential future implications of this pandemic, which is driving vaccine R&D at speeds unlike anything seen even in fast-tracked drug development. And this in turn impacts all aspects of development.

    Other challenges being mitigated on the path to discovering a viable vaccine include issues concerning package selection and systems, as well as storage. Typically, selecting a package system for a vaccine platform may not present as many complicating factors – as ample time would be available for evaluation of compatibility with the vaccine. However, for SARS-CoV-2, regardless of whether the vaccine platform being studied and potentially used already exists or is new, these evaluations are being accelerated. This can create varying degrees of added risk.

    For example, the selection of vial/stopper primary package systems from manufacturing through delivery is a key consideration in vaccine development. However, specific to SARS-CoV-2, this selection process becomes compounded by expedited timelines, in addition to the fact that various technologies and platforms are being explored – each of which may have different requirements to assure stability, quality and delivery.

    An example of this is that typically, primary package systems for vaccines employ glass vials. But, with the increased demand resultant from the SARS-CoV-2 pandemic, potential glass vial shortages and unacceptable lead times, alternatives such as polymer vials may also need to be considered.

    CP: How is the COVID-19 pandemic impacting West’s products/services/operations?

    FD: We are committed to doing our part to speed the successful development and large-scale manufacture of high-quality components required to serve customer needs for the delivery of a safe and effective SARS-CoV-2 vaccine, which includes expanding labor and equipment resources.

    In an effort to best support our customers investigating potential vaccine candidates for SARS-CoV-2, West has made it a practice to preemptively assess needs, evaluate which of our products and services could be most of use and ensure operations are available at needed scale.

    For instance, across the six platforms currently being considered for SARS-CoV-2 vaccine candidates, West offers product solutions that may help optimize quality to safety from manufacture through delivery in the midst of compressed timelines. This includes offerings that can mitigate the migration of leachables from and interactions between the closure and the vaccine product, while enabling proven package system container closure integrity. And many of our relevant products are already globally available and market accepted, with options available in varying sizes and configurations – which may help reduce certain risk, since accelerated vaccine development timelines cannot accommodate standard evaluation within potential packaging systems.

    As the COVID-19 situation continues to evolve, we remain committed to supporting and delivering for our customers, patients, and employees – while never compromising on safety. Our teams are constantly monitoring to ensure we have the most optimal protocols in place within our operations in accordance with guidance from leading experts, and are working to help minimize the impact of potential logistical and supply challenges that may arise outside of our scope of control.

    This also includes capital investments to shore up areas of our robust manufacturing program as needed, as demand for supplies needed for use with treatments to combat COVID-19 has increased across the board – even beyond vaccine development.
     


    Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and delivery industry, with extensive expertise in injectable drug products, including vial container closure systems and prefillable systems for combination products.  Fran has held numerous technical roles at West, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories and Scientific Affairs.  In her current role as Chief Scientific Officer, she is responsible to leverage scientific and regulatory understanding across the enterprise.  Fran received the Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Business Woman’s Association Luminary Award for West in 2017.

    Suggested For You
    Reshaping the Pharmaceutical Supply Chain Reshaping the Pharmaceutical Supply Chain
    J&J’s Single-Dose COVID-19 Vax Issued EUA J&J’s Single-Dose COVID-19 Vax Issued EUA
    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply AMRI Contributes to Efforts to Increase COVID-19 Vax Supply
    Pfizer, BioNTech To Supply 200M More Vax Doses to EU Pfizer, BioNTech To Supply 200M More Vax Doses to EU
    Novavax, SK Bioscience Expand Vax Pact Novavax, SK Bioscience Expand Vax Pact
    Kaneka Eurogentec Expands Capabilities Kaneka Eurogentec Expands Capabilities
    FUJIFILM Diosynth Hosts UK PM at COVID Vax Mfg. Site FUJIFILM Diosynth Hosts UK PM at COVID Vax Mfg. Site
    Pfizer, BioNTech to Supply the U.S. with 100mn Additional Doses of COVID-19 Vaccine Pfizer, BioNTech to Supply the U.S. with 100mn Additional Doses of COVID-19 Vaccine
    Evonik Strengthens Partnership with BioNTech on COVID-19 Vaccine Evonik Strengthens Partnership with BioNTech on COVID-19 Vaccine
    Pfizer Pfizer's 4Q Revenues up 12%
    Inside a Vaccine Trial Inside a Vaccine Trial
    J&J Submits EUA for Single-Shot Janssen COVID Vax Candidate J&J Submits EUA for Single-Shot Janssen COVID Vax Candidate
    UK Secures 40M Doses of Valneva COVID-19 Vax UK Secures 40M Doses of Valneva COVID-19 Vax
    CureVac, Rentschler Ramp up COVID Vax Production CureVac, Rentschler Ramp up COVID Vax Production
    Novartis Inks Contract Manufacturing Deal for Pfizer-BioNTech COVID-19 Vaccine Novartis Inks Contract Manufacturing Deal for Pfizer-BioNTech COVID-19 Vaccine

    Related Online Exclusives

    • Cold Chain Management | Logistics | Packaging & Tracking | Supply Chain
      Reshaping the Pharmaceutical Supply Chain

      Reshaping the Pharmaceutical Supply Chain

      The pandemic and COVID-19 vaccines bring navigating the cold-chain and preserving precious biologics to the forefront.
      Kristin Brooks, Managing Editor 03.01.21

    • Solid Dosage/Creams/Ointments
      Solid Dose Market Trends

      Solid Dose Market Trends

      A Q&A with Mark DaFonseca, chief business officer at CoreRx.
      Tim Wright, Editor, Contract Pharma 02.26.21

    • Drug Delivery
      Aerosol Delivery Devices Market

      Aerosol Delivery Devices Market

      Advantages over conventional drug delivery devices, rise in prevalence of COPD and asthma drive the growth of the global aerosol delivery devices market.
      Allied Market Research 02.16.21


    • Biologics, Proteins, Vaccines | Clinical Trials
      Inside a Vaccine Trial

      Inside a Vaccine Trial

      Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.
      Kristin Brooks, Managing Editor 02.05.21

    • Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development
      The Future of Vaccines and Biologics

      The Future of Vaccines and Biologics

      Dr. Linda Marbán of Capricor Therapeutics discusses the advances in responding to infectious diseases.
      Kristin Brooks, Managing Editor, Contract Pharma 02.04.21

    • Clinical Trials | Information Technology
      The State of Clinical Trial Technology

      The State of Clinical Trial Technology

      Blake Adams of Florence discusses key report findings and the clinical trial software used to support Pfizer’s global COVID-19 vaccine study.
      Kristin Brooks, Contract Pharma 01.26.21


    • Analytical Services | Laboratory Testing
      Improving Product Profitability

      Improving Product Profitability

      Using PAT/QbD/CM as tools to increase profitability of products.
      Emil Ciurczak, Contributing Editor 01.21.21

    • Analytical Services | Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development | Fill/Finish
      A New Era of Vaccine and Biologic Drug Development

      A New Era of Vaccine and Biologic Drug Development

      As a result of COVID-19, unprecedented investments in vaccines, diagnostics, and treatments have had a tremendous impact on the Biotechnology industry.
      Kristin Brooks, Managing Editor 01.12.21

    • Clinical Trials | Drug Development | Information Technology
      Advancing Digital Endpoints in Clinical Trials

      Advancing Digital Endpoints in Clinical Trials

      An end-to-end approach to managing wearable devices through clinical development.
      Kristin Brooks, Contract Pharma 12.14.20


    • Drug Delivery | Drug Development
      Inhaled Drug Delivery Technology Trends

      Inhaled Drug Delivery Technology Trends

      The success of new inhaled medicines relies on the correct combination of formulation and device technology.
      Dr. Sandy Munro, Vice President – Pharmaceutical Development, Vectura 11.24.20

    • Bioanalytical Services | cGMP Manufacture | Drug Development | Scale-up/Technology Transfer
      CDMOs: Keeping up with Science & Technology

      CDMOs: Keeping up with Science & Technology

      Enhancing the development of increasingly advanced and complex drug candidates is needed to drive growth in the industry.
      Kristin Brooks, Contract Pharma 11.12.20

    • Excipients
      Pharmaceutical Excipients Market Poised for Growth

      Pharmaceutical Excipients Market Poised for Growth

      The global pharmaceutical excipients market is estimated to surpass $11,944.6 million by 2027.
      Contract Pharma Staff 11.03.20


    • cGMP Manufacture | Fill/Finish | Scale-up/Technology Transfer
      Ramping Up COVID-19 Vaccine Fill and Finish Capacity

      Ramping Up COVID-19 Vaccine Fill and Finish Capacity

      As a partner to the U.S. Government, GRAM's newest facility was designed to increase large-scale fill and finish capacity with room to expand as demand grows.
      Kristin Brooks, Contract Pharma 11.03.20

    • Biologics, Proteins, Vaccines
      India Emerges as Hot Spot for Manufacturing COVID-19 Vaccines

      India Emerges as Hot Spot for Manufacturing COVID-19 Vaccines

      CMOs expand and ‘repurpose’ capacities.
      S Harachand, Contributing Editor 10.20.20

    • Clinical Trials | Drug Development | Preclinical Outsourcing
      Accelerating R&D Trends

      Accelerating R&D Trends

      The pandemic has propelled lingering trends into the forefront and increasingly complex molecules and biologics have drug developers outsourcing more.
      Kristin Brooks, Contract Pharma 10.20.20

    Trending
    • Four Female Leaders Appointed To Cell & Gene CDMO
    • BMS Expands Cell Therapy Manufacturing Capabilities
    • Reed-Lane Facility Virtual Tour
    • Matica Biotechnology Breaks Ground On Cell And Gene Therapy Site
    • Genesis Drug Discovery & Development Acquires Integrated Analytical Solutions
    Breaking News
    • AGC Biologics Expands Cell and Gene Facility in Italy
    • Celonic to Boost Cell & Gene Therapy Production
    • Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie
    • Aptamer Extends Collaboration with AstraZeneca
    • Fujifilm Breaks Ground on Major Expansion of Biologics Facility in Denmark
    View Breaking News >
    CURRENT ISSUE

    March 2021

    • Hygienic Packaging Technology
    • Trends in Solid Oral Dosage Delivery
    • 5 Reasons Paper Has No Place in Contract Manufacturing
    • Injectable Drug Delivery Trends
    • Pharmaceutical Manufacturing Equipment Trends
    • Oral Solids: Market & Technology Trends
    • Nutraceutical Manufacturing: Meeting the Challenges of Today, Planning for Tomorrow
    • 2021 Contract Manufacturing Survey
    • Small Molecule Development Trends
    • Challenges & Opportunities Facing Small & Emerging Biopharma Companies
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Thymoquinone Inhibits Viral Infection in In Vitro Settings, New Study Finds
    IFT Transitions 2021 Annual Event to Digital Experience
    NY Federal Judge Enters Permanent Injunction Against Dietary Supplement Manufacturer
    Coatings World

    Latest Breaking News From Coatings World

    Sherwin-Williams Announces Resignation of President and COO
    Ashland Completes Expansion and Relocation of Viatel Bioresorbable Polymers Manufacturing Facility
    Evonik Receives Sustainability Award from EcVadis
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Cretex CFO Announces Retirement
    New AI-Based Tool Developed for Coronary Artery Analysis, Intervention Planning
    First Reported Use of Pulse Biosciences' CellFX System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    AGC Biologics Expands Cell and Gene Facility in Italy
    Celonic to Boost Cell & Gene Therapy Production
    Pharmaron Acquires Biomanufacturing Site in the UK from AbbVie
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Ulta Beauty Opens in Herald Square
    Elizabeth Arden Taps Sui He as Global Brand Ambassador
    Natura &Co Outperforms the Global Market in Q4 2020
    Happi

    Latest Breaking News From Happi

    What You're Reading on Happi.com
    Indie Beauty Innovators Wanted
    Cosmetic Chemists Seek Mentors
    Ink World

    Latest Breaking News From Ink World

    Massilly North America Adds Koenig & Bauer MetalStar 3 Metal Decorating Press
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Access Direct Mail Doubles Revenue with SCREEN's Truepress Jet520HD
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Arjobex America welcomes Maggie Naberezny to sales team
    Henkel publishes 30th Sustainability Report
    Avery Dennison Smartrac launches new Circus Pro inlays
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    FPInnovations Develops Biodegradable Mask
    Sani Professional Sanitizing and Disinfecting Products Approved by EPA
    Autefa Solutions Offers Fully Automated Line for Protective Mask Production
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Colfax Decides to Divide Its Businesses
    Stryker Corp.'s 2020 Sales Slip 3.6 Percent
    Bioventus Appoints Managing Director, China and Asia Pacific
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View Research

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login