• 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
    Bye-Bye China?

    Decentralized Trials Fuel AI Revolution in Clinical Research

    Self-Medication: Flexibility for Patients and Drug Manufacturers

    The Single-Use Mixing Landscape: Evaluating Your Options

    DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    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
    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio

    Frontage Bolsters Clinical Services Capabilities

    Sanofi Unveils EUROAPI as Name of New European API Company

    Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz

    Precision Medicine Group Acquires Project Farma
    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

    Sanofi Unveils EUROAPI as Name of New European API Company

    Precision Medicine Group Acquires Project Farma

    Cytiva Delivers Modular Biologics Factory to Lonza

    Fujifilm, CABIM Get $76M Funding for Mfg. and Innovation Center

    LSNE Expands Fill Finish and Lyophilization Ops
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Catalent Acquires Acorda’s INBRIJA Manufacturing Operations

    Varcode, PL Developments Form Strategic ‘Smart Tag’ Pact

    COVID-19 Vaccine Distribution: The Air Cargo Industry’s Greatest Challenge

    Thermo Fisher Expands Clinical Supply Services in Europe

    Schreiner MediPharm Joins DoseID Consortium
    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

    Virtual Clinical Trials: The Future of Dermatology Studies

    Frontage Bolsters Clinical Services Capabilities

    Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz

    Precision Medicine Group Acquires Project Farma

    Cytiva Delivers Modular Biologics Factory to Lonza
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Gene Therapy Co. Selects ValGenesis' SaaS Platform

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

    Samsung Biologics Adopts Veeva Vault QMS to Unify Quality Management

    CDMO Cognate BioServices Teams Up with L7 Informatics

    The Wasdell Group Earns ISO 13485 Certification
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Flow Sciences

    Alcami

    Adare Pharma Solutions

    Reed-Lane

    Syngene
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Flow Sciences

    Syngene

    PCI Pharma Services

    Adare Pharma Solutions

    Aphena Pharma Solutions
    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

    Growth in Biologics and Maintaining Patient Satisfaction

    Vicki A. Barbur of Battelle discusses the driving forces for biologics, the challenges, and new delivery methods

    Growth in Biologics and Maintaining Patient Satisfaction
    Related CONTENT
    • Legacy Pharma Solutions
    • PCI Pharma Services
    • Catalent Pharma Solutions
    • Regis Custom Pharma
    • Adare Pharma Solutions
    Kristin Brooks, Contrct Pharma08.09.19
    While injections have been the delivery method of choice for certain diseases and drug products, biologics present new and complex challenges creating the need for better, more reliable, patient friendly delivery methods. Increasingly pharma and biopharma companies are focusing on providing a consumer-compatible form of delivery and packaging to maintain patient compliance and satisfaction. As such, the next generation of autoinjectors needs to incorporate the latest technologies in new and improved ways.

    Vicki A. Barbur, Ph.D., Senior Director, Battelle, Columbus OH, discusses the driving forces for biologics and new delivery methods. –KB
     
    Contract Pharma: What are the driving forces for biologic drugs and new delivery vehicles?

    Vicki A. Barbur: Pharmaceutical research continues to expand in search of solutions to address chronic conditions that can be impacted by treatments received daily, weekly, bi-weekly, or even monthly. Progressively, these treatments require underlying chemical compositions that are frequently incompatible with traditional forms of systemic delivery to the body (e.g., oral capsules), and among the compatible delivery pathway options the preference among many pharmaceutical companies has been liquid formulations for subcutaneous injection. Many drugs in this class are characterized by physical properties and sensitivities that challenge the drug commercialization ecosystem. For example, monoclonal antibodies, perhaps the most significant category in terms of therapeutic and commercial importance, typically possess viscosities that are well above the normal limits of subcutaneous injection techniques. Drug developers and device designers are increasingly working in collaboration to address the goal of patient self-administration for biological injectables, and to increase compliance, they are also focused in parallel on reducing the ‘dosing’ burden by making each dose last longer in the body.

    This resulting delivery pathway has been well characterized and is confirmed to be well tolerated by millions of patients each year. For example, according to the Centers for Disease Control and Prevention (CDC), in the U.S. between 2013-2015, approximately 54.4 million adults have been diagnosed with various types of inflammatory disease such as, gout, lupus, rheumatoid arthritis or fibromyalgia. It is primarily these diseases that are treated with injectable therapeutics, and most likely going forward, with biologics that have large molecules as their base. This is driving the need for new and innovative autoinjectors and its subsequent growth potential as a market opportunity. An auto-injector is a small, pen shaped device, which contains a hypodermic needle used for delivering a fixed dose of drug to patients. Autoinjectors are intended to be easy to use and intended for self-administration by patients or any other caretaker. 
     
    CP: Why are the design factors in autoinjectors being challenged by biologics?

    VB: The subcutaneous injection treatment pathway has subsequently created an industry of providers that offer delivery solutions that accommodate most traditional forms of liquid drugs. However, the rise in the use of biologics based on large molecules and often higher viscosity liquids linked in part by the concentration of active ingredients along with subcutaneous delivery, are driving the need for new and innovative autoinjectors, thus its subsequent growth potential in the market. A traditional liquid drug is generally characterized by a stable liquid requiring 1ml of delivery per dose/injection or less. Currently, there are few solutions that adequately address the combination of larger volumes (greater than 1ml) and higher viscosity doses, and where the needs of the patient are also considered, namely, with comparable injection times (less than 10 seconds), insertion forces (lowest pain threshold possible), and injection forces (lowest pain threshold possible and maximization of mechanical advantage). These new requirements entail a complex combination of needle length, needle bore, viscosity and syringe forces in order to comfortably deliver the required system for patient use without the resulting pain profile or other tradeoffs that limit the product’s success in the market.  
     
    CP: What accessibility is there to new autoinjectors?

    VB: Novel autoinjectors are currently in development to address the large molecule, high viscosity, and higher volume liquid drug delivery challenges noted above. This next generation of autoinjectors leverages mature technology in novel ways, for example using combination compression and torsion springs, to power the injection through controlling force applied to plunger.

    It is expected that next generation autoinjectors will deliver substantial benefits for patients and manufacturers. As the number of high viscosity drug formulations increase, these newer autoinjectors will enable comparable delivery to existing low viscosity formulations and make delivery more comfortable for patients. Potential benefits include:
    • Reduced delivery time for lower-viscosity drugs
    • Soft, controlled insertion for a more comfortable injection experience
    • Reduced risk of breaking the syringe during use
    • A quieter and more discrete delivery mechanism
    • Smaller device package size
     

     

    Overall the autoinjectors market is projected to grow at a CAGR of 24.2% during the forecast period of 2018-2023. The global autoinjectors market is expected to reach $85.3B by 2023 from an estimated $28.9B in 2018.
     
    Longer lifespans are expected to translate to a growing number of patients diagnosed with chronic conditions. To counteract the financial and medical infrastructure implications of this trend, pressure from federal programs and managed care organizations will place high significance on therapeutic self-administration, an expectation that is creating an increased interest in approaches for routine delivery that are patient-friendly, can be self-managed and are also cost-effective. Pharmaceutical companies are realizing that for many products, success no longer solely depends on the medication itself delivering therapeutic success, and that they also need to increase focus on providing a consumer-compatible form of packaging and an application methodology that maintains patient satisfaction.


    Vicki A. Barbur, Ph.D., is Senior Director, IP and Technology Commercialization, Commercial Business at Battelle. She brings dual expertise in science and business as well as broad experience in several technical disciplines to her overarching role as an innovative growth leader associated with technology commercialization and IP management. Her primary areas of focus are Health and Medical Devices, as well as Genomics and BioSecurity. Previously, Barbur was SVP and CTO for Concurrent Technologies Corporation and VP, R&D for Cardinal Health. In October 2016, she joined The MITRE Corporation supporting the Technology Transfer Office. Barbur earned a PhD and BSc in physics from Imperial College, University of London, and a MSc in Applied Statistics from the University of Oxford, both in the UK.
    Related Searches
    • biologics
    • auto-injector
    • contract pharma
    • Technology Transfer
    Suggested For You
    Legacy Pharma Solutions Legacy Pharma Solutions
    PCI Pharma Services PCI Pharma Services
    Catalent Pharma Solutions Catalent Pharma Solutions
    Regis Custom Pharma Regis Custom Pharma
    Adare Pharma Solutions Adare Pharma Solutions
    Four Pitfalls to Avoid When Packaging Injectable Drug Products Four Pitfalls to Avoid When Packaging Injectable Drug Products
    La Jolla Pharma Receives Orphan Designation for Malaria Treatment La Jolla Pharma Receives Orphan Designation for Malaria Treatment
    Knowledge Sharing in the Development and Delivery of Biologics Knowledge Sharing in the Development and Delivery of Biologics
    The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up? The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up?
    Cambrex Makes Senior Appointments Cambrex Makes Senior Appointments
    Camargo to Acquire InSymbiosis Camargo to Acquire InSymbiosis
    Particle Sciences Expands Controlled Substance Capabilities Particle Sciences Expands Controlled Substance Capabilities
    Alector, Lonza Partner for Mfg. of Neurodegeneration Therapies Alector, Lonza Partner for Mfg. of Neurodegeneration Therapies
    Ology Wins Two DoD Awards Ology Wins Two DoD Awards
    The Embedded CDMO The Embedded CDMO

    Related Online Exclusives

    • 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

    • 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

    • 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


    • Drug Delivery
      Topical Drugs Poised for Growth

      Topical Drugs Poised for Growth

      The topical drug delivery market is projected to reach $129.8 billion by 2025 from $95.2 billion in 2020, at a CAGR of 6.4%.
      Contract Pharma Staff 10.12.20

    • Drug Delivery
      Drug Delivery Market Report

      Drug Delivery Market Report

      The pharmaceutical drug delivery market was valued at $1,403,082.9 million in 2019 and is projected to reach $2,296,170.9 million by 2027.
      Contract Pharma Staff 10.12.20

    • Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
      Expediting a COVID-19 Vaccine: FDA Approval Process

      Expediting a COVID-19 Vaccine: FDA Approval Process

      The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.
      Kristin Brooks, Contract Pharma 08.25.20


    • Drug Delivery | Solid Dosage/Creams/Ointments
      MedPharm Expands U.S. Footprint

      MedPharm Expands U.S. Footprint

      UK topical and transdermal firm invests in $4 million expansion of laboratory facility in Durham, NC.
      Tim Wright, Editor, Contract Pharma 07.23.20

    • Biologics, Proteins, Vaccines | Drug Discovery
      Cell Therapy for Solid Tumors

      Cell Therapy for Solid Tumors

      Is base editing the solution for solid tumor-based cell therapy?
      Jonathan Frampton, Corporate Development Partner, Horizon Discovery 06.26.20

    • Analytical Services | Biologics, Proteins, Vaccines | Drug Development | Drug Discovery | Laboratory Testing
      A Shifting Drug Development Landscape Amid COVID-19 Crisis

      A Shifting Drug Development Landscape Amid COVID-19 Crisis

      Responding to demand for challenging assays and custom solutions required for complex molecules, biologics, vaccines and other innovative therapies.
      Kristin Brooks, Contract Pharma 06.22.20


    • Biologics, Proteins, Vaccines | cGMP Manufacture | Clinical Trials | Drug Development | Scale-up/Technology Transfer
      Rapid Delivery of Medical Countermeasures Amid Pandemic

      Rapid Delivery of Medical Countermeasures Amid Pandemic

      Robert Erwin of iBio discusses the company’s COVID-19 vaccine development efforts and FastPharming manufacturing platform for the rapid delivery of vaccines
      Kristin Brooks, Contract Pharma 04.03.20

    • Biologics, Proteins, Vaccines | Clinical Trials | Drug Development
      COVID-19 Vaccine Response

      COVID-19 Vaccine Response

      ICON execs discuss developments in vaccine research efforts and key challenges of delivering a coronavirus vaccine
      Kristin Brooks, Contract Pharma 04.01.20

    • Biologics, Proteins, Vaccines | cGMP Manufacture | Clinical Trial Materials | Drug Development
      Newsmakers: Thermo Fisher Scientific

      Newsmakers: Thermo Fisher Scientific

      Leon Wyszkowski discusses the company’s recent investments, the challenges biopharma companies face, and future needs in the outsourcing space
      03.16.20


    • Biologics, Proteins, Vaccines | Breaking News | Clinical Trials | Drug Development
      COVID-19 Clinical Trials

      COVID-19 Clinical Trials

      The vaccines in development for COVID-19, who's developing them, and where they stand in the development process
      Kristin Brooks, Contract Pharma 03.10.20

    • Bio News | Biologics, Proteins, Vaccines | cGMP Manufacture
      Newsmakers: Vigene Biosciences

      Newsmakers: Vigene Biosciences

      Dr. Jeffrey Hung, Chief Commercial Officer, discusses Vigene’s new $20 million lab and strategic partnership with ASC Therapeutics
      Kristin Brooks, Contract Pharma 02.20.20

    • Biologics, Proteins, Vaccines | Clinical Trials | Drug Development | Industry News
      Outsourcing in the Cell & Gene Therapy Space

      Outsourcing in the Cell & Gene Therapy Space

      Specialized and coordinated capabilities aim to accelerate drug development and reduce risk for sponsors
      Kristin Brooks, Contract Pharma 02.04.20

    Trending
    • Fujifilm To Invest $2B In US Manufacturing Site
    • Baxter, Novavax Ink Sterile Manufacturing Agreement
    • A New Era Of Vaccine And Biologic Drug Development
    • Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz
    • Roche Canada To Invest $500M To Create 500 Jobs In Ontario
    Breaking News
    • KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    • Frontage Bolsters Clinical Services Capabilities
    • Sanofi Unveils EUROAPI as Name of New European API Company
    • Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz
    • Precision Medicine Group Acquires Project Farma
    View Breaking News >
    CURRENT ISSUE

    November/December 2020

    • Modeling Process Safety Workflows in Pharmaceutical Manufacturing Scale-Up
    • Ensuring Quality During the Transfer and Scale Up of Rx Drugs
    • Inspecting the Unexpected
    • Cold Chain Trends
    • Catering for the Complex
    • Biopharma Contract Manufacturing: Robust Growth Ahead
    • DCAT President Talks COVID-19, Drug Manufacturing and Innovation
    • The Single-Use Mixing Landscape: Evaluating Your Options
    • Self-Medication: Flexibility for Patients and Drug Manufacturers
    • Decentralized Trials Fuel AI Revolution in Clinical Research
    • 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

    Brown Fat Associated with Reductions in Chronic Disease Risk
    NIH Study Identifies Antibacterial Properties in Taurine
    NSF Begins New Certification Program
    Coatings World

    Latest Breaking News From Coatings World

    Zeppelin Acquires MTI Mischtechnik
    Ezio Braggio Joins ChemQuest Europe
    IFS Coatings Announce Carbon Offset Program
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Optimize EP Launches CaRM Cardiac Device Data Management Platform
    U.S. TAVR Market Projected to Reach Nearly $5 Billion by 2030
    FDA Clears Canon Medical's Compressed SPEEDER for 3D Exams on 1.5T MR
    Contract Pharma

    Latest Breaking News From Contract Pharma

    KORSCH, MEDELPHARM Partner on R&D Equipment Portfolio
    Frontage Bolsters Clinical Services Capabilities
    Sanofi Unveils EUROAPI as Name of New European API Company
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Neenah to Host Packaging Webinar for Printers
    W.S. Badger is Named a ‘150 Top Impact Company’
    Mana Products, Meiyume and RPG Form The Vertical Beauty Alliance
    Happi

    Latest Breaking News From Happi

    A Surge in Interest for Supplements & Vitamins
    P&G, L'Oréal & Amorepacific Make News at CES
    Three Form Vertical Beauty Alliance
    Ink World

    Latest Breaking News From Ink World

    dar-tech, inc. Becomes U.S. Midwestern Distributor for ZS Interpolymer
    Techkon USA, Konica Minolta Partner
    Alon Bar-Shany Appointed Chairman of Highcon Board
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Exhibitor registration opens for virtual.drupa
    FTA planning in-person Forum & INFOFLEX
    Fortis Solutions Group achieves SGP certification
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Shemesh Adds U.S. Headquarters
    TZMO USA, Special Needs Group Form Partnership
    BAHP Announces 2021 Officers, Board of Directors
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Rapid Recovery Protocol Can Lead to Increased Range of Motion After TKA
    Boston Scientific Releases WaveWriter Alpha Spinal Cord Stimulators in U.S.
    New Chief Clinical Officer on Board at IncludeHealth
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Roadsimple Modernizes Warehouse Ops with Zebra Technologies
    Toppan Announces 2050 Environmental Vision
    SOI Industry Consortium Joins SEMI as Strategic Association Partner

    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