• 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
    Civica to Build an Essential Medicines Manufacturing Facility in Virginia

    Humanigen, Emergent Enter Covid-19 Partnership

    Samsung Bioepis Opens New Headquarters

    Pfizer, BioNTech Enter Vax Pact with COVAX

    FDA Approves Janssen’s CABENUVA
    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

    Civica to Build an Essential Medicines Manufacturing Facility in Virginia

    Humanigen, Emergent Enter Covid-19 Partnership

    Samsung Bioepis Opens New Headquarters

    Integrated Continuous Manufacturing ICM

    CONTINUUS Awarded $69.3M DoD Grant
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Civica to Build an Essential Medicines Manufacturing Facility in Virginia

    WDSrx Expands Warehouse Network

    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
    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

    Humanigen, Emergent Enter Covid-19 Partnership

    Samsung Bioepis Opens New Headquarters

    Lilly Completes $1B Acquisition of Prevail

    Top BioPharma Form Accumulus Synergy

    Coating Place Wurster Fluid Bed Process Scaling
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    Top BioPharma Form Accumulus Synergy

    Global Biosciences Co. Selects ValGenesis VLMS

    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
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Aphena Pharma Solutions

    Syngene

    Reed-Lane

    Cytovance Biologics

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

    Cytovance Biologics

    PCI Pharma Services

    Aphena Pharma Solutions

    Adare 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

    Contracting & Outsourcing Session Highlights and Key Takeaways

    Insight into CMO Trends, Biotrends, Manufacturing Compliance, FDA Quality Agreements, and CMO Oversight

    Contracting & Outsourcing Session Highlights and Key Takeaways
    Related CONTENT
    • Vetio Animal Health
    • Contracting And Outsourcing Agenda
    • CMO/CDMO Sector Mega-Mergers & Acquisitions
    • What’s Next for the CDMO Business?
    • CMO Oversight: What is the Client’s Role?
    Kristin Brooks, Contract Pharma10.09.17
    The following offers brief summaries of a few of the presentations from the 2017 Contracting & Outsourcing Conference.
     
    Contract Manufacturing Market Trends Update  

     Jim Miller
    Jim Miller of Pharmsource highlighted recent and robust performance from CDMOs. For the first half of 2017, revenue growth rates for drug development services for companies such as Patheon, Catalent, and AMRI, were between 10-20%. API revenue growth from providers including Patheon, Lonza, and AMRI were between 15% and 25%. Revenues related to dose for companies including Patheon, AMRI, Catalent and Baxter, were between 2% and 10%.
     
    While outsourced FDA approvals are up, and emerging biopharma funding is driving development, Mr. Miller also pointed out potential challenges facing the CDMO industry.
    For example, emerging biopharma spending can slow with shifts in financial markets, or failure of a major therapeutic class, and unfavorable pricing decisions.
                                                                      
    He also noted that resources needed for growth may be hard to access. CMOs would not benefit if small and mid-size biopharma approvals decline. Also, fewer CMOs are benefitting from high-value drug approvals. Additional factors to consider are: pricing pressures could hurt development, and a mismatch between product pipeline and CMO capabilities.
     
    Mr. Miller went on to say, the near-term outlook is robust. Also, market entry, scale, new capabilities and finance are driving M&A as evidenced by several recent deals. For example, strategic-based deals such as ThermoFisher/Patheon, and Lonza/Capsugel; add-on service acquisitions such as Catalent/Accucaps and Lonza/Pharmacell, and financial investments such as Carlyle Group/AMRI, and Permira/LSNE.
     
    Biotrends Report: Top 5 Global Trends Affecting Biopharma Outsourcing  
    Eric Langer of BioPlan Associates discussed the top biotrends based on a recent report: Industry Growth; Demand for Efficiency; International Biomanufacturing Centers; Biosimilars; Cell Therapies; and Hiring and Training Staff.
     
    Based on the report, of the biomanufacturing services that are increasingly outsourced, analyticial testing ranks the highest at 90%, followed by toxicity testing at 81%, and fill/finish at 73%, with validation services, product characterization, and contract research at or near 70%. These levels are project to rise with the greatest increases in the next 24 months.
     
    Geographically, outsourcing destinations over the next five years are projected as follows: the U.S. ranked the highest at 31%, followed by Ireland and India, both 18%. China stands at 16%, and Germany at 13%.
     
    The top global trend this past year, according to the report, is manufacturing efficiency and productivity. CMOs offering speed and efficiency are in demand. Also, emerging markets of China and India have fewer legacy facilities and are going state-of-the art. Additionally, more biosimilar development has led to more facilities and more competition. Of the 700-plus biosimilars in development, the majority are from virtual companies with no manufacturing capability. We should expect many new facilities that utilize SUS (single-use systems). Finally, the #5 trend is a healthy 14%~ biopharma industry segment growth. The past 14 years have shown consistent growth between 12-15%.  
     
    CMO Oversight: What is the Client’s Role?

     Jason Condon
    When it comes to Biomanufacturing Readiness Jason Condon of Vaccinex emphasized the active review of all processes and procedures of a manufacturing campaign at a CMO so as to ensure successful manufacture of the product on time and within budget.  He said to focus on what is important for bio/pharma manufacturing: Documentation; Raw Materials & Consumables; Equipment; Manufacturing Operations; Facility; Personnel; Quality Control; and Packaging & Labeling.
     
    This readiness process should include a checklist with questions regarding equipment and the facility, for example. There should be a readiness agenda and a visit. He notes that you must go on site as part of the readiness process as this provides access to documents and records your CMO wouldn’t otherwise be able to share, and helps build a relationship. 
     
    Progress & Challenges in Pharmaceutical Manufacturing Compliance
    Paula Katz of the FDA emphasized that even in a complex market, everyone is responsible for quality. She noted that CMOs and their customers should work together proactively to characterize and control risks to product quality and patient safety and to address any quality issues.
     
    Take the following considerations and perspectives into account: When it comes to the relationship, was the selection process for the contract manufacturing relationship appropriate and robust? Are the roles/responsibilities appropriate in all instances?
     
    With deviations and investigations, what should each organization have done as part of the investigation and what is each organization’s role now? What additional controls, if any, are needed for continued manufacture and use of product?
               
    Regarding an inspection, what should be the approach for responding to the 483 observations?
    Who should be involved in preparing the responses?
     
    Ms. Katz said to focus on product quality, as a comprehensive evaluation and risk assessment feeds into quality-focused corrective actions. 
     
    FDA Quality Agreements Guidance
    Paul Mason of Lachman Consultant Services noted that when it comes to responsibilities, each party engaged in the manufacture of a drug is responsible for ensuring compliance with CGMP for the manufacturing activities it performs. He added, the owner takes responsibility of ensuring that any contracted activity was compliant with the cGMP requirements and meets the specific requirements of the final API/Product. Also, the requirements of Quality Agreements should be integral to the owner’s Pharmaceutical Quality System along with the process by which a contract facility is qualified and continually monitored. He noted, the owners Pharmaceutical Quality System should ensure control over outsourced activities including purchased materials.
     
     
    Related Searches
    • pipeline
    • validation services
    • packaging
    • contracting
    Suggested For You
    Vetio Animal Health Vetio Animal Health
    Contracting And Outsourcing Agenda Contracting And Outsourcing Agenda
    CMO/CDMO Sector Mega-Mergers & Acquisitions    CMO/CDMO Sector Mega-Mergers & Acquisitions
    What’s Next for the CDMO Business? What’s Next for the CDMO Business?
    CMO Oversight: What is the Client’s Role? CMO Oversight: What is the Client’s Role?
    Quality Agreements Guidance Quality Agreements Guidance
    Progress & Challenges in Pharmaceutical Manufacturing Compliance Progress & Challenges in Pharmaceutical Manufacturing Compliance
    Outsourcing Partnerships:  Trends in the CDMO Sector Outsourcing Partnerships: Trends in the CDMO Sector
    Thermo Fisher Completes Acquisition of Patheon Thermo Fisher Completes Acquisition of Patheon
    4 Roche 4 Roche
    Patheon to Invest $45M to Expand Capabilities  Patheon to Invest $45M to Expand Capabilities
    Heading to BIO 2017! Heading to BIO 2017!
    Caelum Biosciences, Patheon Ink Bio Mfg. Pact Caelum Biosciences, Patheon Ink Bio Mfg. Pact
    Recipharm Makes Appointment in the UK & Ireland Recipharm Makes Appointment in the UK & Ireland
    Thermo Fisher Buys Patheon for $7.2B Thermo Fisher Buys Patheon for $7.2B

    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

    • 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

    • 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

    • 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 Development | Information Technology
      Trade Secret Litigation: Vulnerabilities Within Pharma Amid Hacking Efforts

      Trade Secret Litigation: Vulnerabilities Within Pharma Amid Hacking Efforts

      Theft of IP belonging to companies developing biologics and other drugs, including COVID-19 treatments and vaccines, poses a threat to innovation.
      Kristin Brooks, Contract Pharma 08.19.20

    • Drug Development | Industry News
      Top Companies Report: Biogen

      Top Companies Report: Biogen

      Expands pipeline of disease-modifying therapies for Alzheimer’s and Parkinson’s, adds gene therapies focused on AAV treatments, bolsters biosimilars portfolio.
      Kristin Brooks, Contract Pharma 07.10.20

    • 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


    • Drug Development | Information Technology
      Advancing AI Initiatives in R&D

      Advancing AI Initiatives in R&D

      Richard Lee of ACD/Labs discusses the possibilities of using AI in R&D, and what this outlook means for IT leaders at pharmaceutical organizations.
      Kristin Brooks, Contract Pharma 06.11.20

    • Clinical Trials | CRO News | Drug Development | Information Technology | R&D
      CRO Industry Update

      CRO Industry Update

      Serge Bodart of IDDI provides insight on the pharma and biopharma trends impacting CROs, outsourcing in today’s market, and advances in clinical research.
      Kristin Brooks, Contract Pharma 04.27.20

    • Drug Development | R&D
      COVID-19 and the Importance of Combating Antimicrobial Resistance

      COVID-19 and the Importance of Combating Antimicrobial Resistance

      Dr. Frank of Working to Fight AMR discusses the global COVID-19 pandemic and the critical need to address the public health crisis of Antimicrobial Resistance
      Kristin Brooks, Contract Pharma 04.13.20


    • 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

    • cGMP Manufacture | Drug Development | Logistics | Supply Chain
      COVID-19: Business Update

      COVID-19: Business Update

      Thermo Fisher Scientific provides perspective on the COVID-19 pandemic and how the company is working to help minimize disruptions
      Kristin Brooks, Contract Pharma 03.30.20

    Trending
    • Integrated Continuous Manufacturing ICM
    • Humanigen, Emergent Enter Covid-19 Partnership
    • Samsung Bioepis Opens New Headquarters
    • CDMO Northway Biotech Expands In U.S.
    • CONTINUUS Awarded $69.3M DoD Grant
    Breaking News
    • Civica to Build an Essential Medicines Manufacturing Facility in Virginia
    • Humanigen, Emergent Enter Covid-19 Partnership
    • Samsung Bioepis Opens New Headquarters
    • Pfizer, BioNTech Enter Vax Pact with COVAX
    • FDA Approves Janssen’s CABENUVA
    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

    Clinical Evidence Suggests Potential Oral Benefits for Curcumin Extract
    Oleic Acid Possibly Implicated in MS Pathology
    NIH Study Compares Low-Fat, Plant-Based to Low-Carb, Animal-Based Diet
    Coatings World

    Latest Breaking News From Coatings World

    APV Engineered Coatings Reflects on 2020
    LINE-X Launches Dealer Program with International Truck
    BCF CEO to Chair Royal Society of Chemistry Surface Coatings Interest Group
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Alleviant's Transcatheter Tech Obtains Breakthrough Status
    Signia Appoints New President
    At-Home COVID-19 Test Kits Boosts Disease Monitoring Capabilities
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Civica to Build an Essential Medicines Manufacturing Facility in Virginia
    Humanigen, Emergent Enter Covid-19 Partnership
    Samsung Bioepis Opens New Headquarters
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Fitglow Beauty Wins Big at Annual Dirty Thinker’s Choice Awards
    e.l.f. Cosmetics Unveils Mint Melt Collection
    Estée Lauder Companies Updates Supply Chain Leadership
    Happi

    Latest Breaking News From Happi

    Some Good News at Inter Parfums
    Professional Beauty Association Names New Executive Director
    Curcumin's Role in Oral Care
    Ink World

    Latest Breaking News From Ink World

    Paragon Expands Direct Mail Capabilities with Ricoh Pro VC70000
    BOBST Demonstrates Future of Flexible Packaging Production at Virtual Open House
    Morancé Soudure France Adds Comexi F2 MC 10-color Flexo Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    VPF launches deep-freeze adhesive
    ProMach strengthens flexible packaging business
    Gallus planning virtual event for March
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Kimberly-Clark Releases Q4, Full Year Results
    Freudenberg to Establish Apparel Interlining Competence Centers
    Minet Adds Spunlace Line in Romania
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    First Patient Implanted With NEXXT MATRIXX SA Cervical Turn-Lock System
    Cretex Companies CEO Steps Down
    Conformis Enters Development & Supply Agreement with SITES Medical
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    First Solar Signs Definitive Agreement to Sell US Development Platform to Leeward
    Imec Technology Taking Off to Space
    North American Semiconductor Equipment Industry Posts December 2020 Billings

    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