• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Manufacturing
    • Packaging
    • Development
    • Compliance
    • Top 20
    • Directory
    • Microsites
    • Events
    • More
  • Magazine
  • News
  • Manufacturing
  • Packaging
  • Development
  • Compliance
  • Top 20
  • Directory
  • Microsites
  • Events
  • Current / Back Issue
    Features
    Editorial
    Columns
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Subscribe Now
    Advertise Now
    Top Features
    SARS-CoV-2 R&D: Is It Over?

    Sustainability: A New Threat or Opportunity for CDMOs?

    Advanced Therapy Manufacturing

    Advanced Therapy Packaging Trends

    CEO Spotlight: Darren Head
    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
    iECURE Enters Agreement with Center for Breakthrough Medicines

    CPDC Enters Clinical Manufacturing Deal with CellBion

    Olon to Build New R&D Center in Italy

    Hanmi Fine Chemical Launches CDMO Business

    DFE Pharma Opens India CoE for Fast-Track Formulation Services
    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

    iECURE Enters Agreement with Center for Breakthrough Medicines

    CPDC Enters Clinical Manufacturing Deal with CellBion

    Olon to Build New R&D Center in Italy

    Hanmi Fine Chemical Launches CDMO Business

    DFE Pharma Opens India CoE for Fast-Track Formulation Services
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Selecting a CMO Partner for Sterile Injectable Manufacturing

    Royalty Pharma and Jefferies Invest $111M in ApiJect

    Cryoport Acquires Cell&Co BioServices for €6.2M

    Challenges of Developing Large Volume Drug/Device Combination Products for Parenteral SC Delivery

    Yourway Adds Capacity for Controlled Ambient Storage
    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

    CRO Market Insights

    Hanmi Fine Chemical Launches CDMO Business

    DFE Pharma Opens India CoE for Fast-Track Formulation Services

    Helsinn Establishes New R&D Hub in the U.S.

    CureVac, myNEO Partner on Antigen Targets for mRNA-Cancer Vax Development
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

    FDA Inspection Trends Update

    Phase-Appropriate cGMP Considerations for Cell and Gene Therapy

    Sustainability: A New Threat or Opportunity for CDMOs?

    In Pursuit of Sustainability: How the Biopharma Industry Can Contribute

    Conducting Clinical Trials During the Pandemic: What Did We Learn?
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    Qosina

    Kyongbo Pharmaceutical

    Vector Partners Limited

    Baxter BioPharma Solutions

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

    Kyongbo Pharmaceutical

    Vector Partners Limited

    Baxter BioPharma Solutions

    Quotient Sciences
    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
    • White Papers
    • Podcasts
    • Infographics
    • Supplier Microsite
      • Companies
      • News Releases
      • Posters
      • Brochures
      • Services
      • Videos
      • Case Study
      • White Papers
    • Contract Pharma Conference
      • Contract Pharma Conference
      • Speakers
      • Exhibitors
      • Conference Sessions
    • 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
    Features

    Ensuring Quality During the Transfer and Scale Up of Rx Drugs

    Defining the key parameters and considerations for a successful technology transfer.

    Ensuring Quality During the Transfer and Scale Up of Rx Drugs
    Related CONTENT
    • Bora Pharmaceuticals
    • Taros Chemicals GmbH & Co. KG
    • W. R. Grace FCMS
    • ViscoTec America Inc.
    • PCI Pharma Services
    Tom Chang, President, Bora Pharmaceutical Laboratory Co. Ltd.11.17.20
    The demand for the services of contract development and manufacturing organizations (CDMOs) has never been higher, with approximately 28% of the world’s prescription and non-prescription drugs being manufactured by an outsourcing partner.1

    The growing use of CDMOs is being driven by the logical need of the industry: large pharma companies can divest non-core manufacturing facilities and focus capital instead on core products, while smaller companies often require the specialist services CDMOs offer to produce increasingly complex drugs cost effectively. For both small and large companies, partnering also allows for the reduction of risk, the management of costs, and ensuring the quality of the manufactured product.

    The importance of the right partnership
    The outsourcing partnership is one based on trust and begins with the technology transfer. When the pharmaceutical company transfers the required IP, the partner receives crucial technical and scientific information, which will allow for the manufacture of a product at a new manufacturing site. The formulation, manufacturing process, analytics, and packaging IP, as well as additional relevant documentation, knowledge, and professional expertise change hands in the process.

    If the technology transfer is handled badly, issues and risks can be introduced all the way through the process. There can be problems with the initial batches, analytical testing, packaging, and potentially patient safety. As a result, it is essential that extra time and effort is taken to outline all relevant parameters, so that product quality does not become an issue and, if it does, that there are adequate warnings. In this article we outline the key parameters and considerations to take into account, to ensure a successful technology transfer.

    Robust risk assessment
    First, it’s critical to conduct a thorough feasibility evaluation at the outset of the technology transfer. A risk assessment should cover all activities included in the technology transfer, where the contracted partner challenges assumptions, offers practical solutions and offers a range of value-based options to address and mitigate potential issues. A good outsourcing partner can identify problems from formulation issues during scale up to spotting regulatory incompatibilities early into the process.

    The more rigorously a process is challenged in the feasibility stage, the more robust that process will be during the scale up, validation, and commercial production phases. The technology transfer may not always be a smooth transition, especially when working with complex oral solid dose drugs, for example, but robust risk assessment is one way to ensure a quality end product.

    Communication is key
    When a technology transfer is executed successfully, both partners stand to gain in terms of time saved and costs minimized, while product quality is improved and performance risk is reduced. Communication to ensure this happens is central to the working relationship.

    Technology transfer is a person-to-person, system-to-system knowledge transfer. In line with this, the better the exchange and communication of information, the greater the likelihood of successfully fulfilling the program’s financial and commercial goals. It is important for sponsors to provide all relevant information, including ‘tribal’ knowledge, in a secure, defined space where the respective organizations can collaborate to develop practical solutions and ensure a robust technical transfer package.

    Three questions
    When choosing an outsourcing partner, it’s worth considering the following questions first:
    • Do they have a similar experience in scaling up similar processes?
    • Are they capable of exploring the design space of parameters and identifying the critical process parameters before scaling up?
    • Can they offer appropriate equipment to scale up and do they have the appropriate knowledge to scale up?

    Critical Quality Attributes (CQA)
    The technical transfer package is not complete until it provides Product Quality Attributes: Critical Quality Attributes (CQAs) and material attributes. A CQA appraisal will include an overview of processes, including unit operations, a control strategy, manufacturing process parameters, continuous improvement ideas and plans, historical deviations lists, and equipment and analytical technology lists.

    SUPAC
    Changes are often made to the manufacturing process after a drug is approved, from the equipment involved to the location of the site itself, or even the composition of the product. These are known as Scale-Up and Post Approval Changes (SUPAC). Any changes made can have an impact on the raw materials involved, manufacturing process, equipment train, manufacturing site, and the batch size. In turn, this can affect the CQAs of a drug or a finished product.

    It is, therefore, necessary to consider in advance the impact of any changes on the quality of a drug or finished product.

    SUPAC guidances provide those sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) recommendations on the following: post-approval changes to components or compositions; the site of manufacture; the scale up/scale down of manufacture; and the manufacturing (process and equipment) of an immediate release oral formulation.

    All in the analytics
    The manufacturing process requires precise controls to ensure the quality of a drug throughout its lifecycle.

    For example, at Bora Pharmaceuticals we utilize a wide range of analytical tools to support product quality, which is especially important to ensure commercial products meet the requirements of regulators and the patients themselves. This involves using Design of Experiments (DoE), risk assessment platforms, and Process Analytical Technologies. Through the utilization of such tools, a design space can be created between partners where the CQA can meet predetermined specifications during technology transfer and scale up activity.

    Through analytical tools and when a sponsor provides reliable process knowledge, the contract manufacturing partner can establish a Normal Operating Range during technology transfer or a scale up activity.

    Engineering runs
    Before the scale up process, engineering (or demonstration) runs are the proving ground for the process and the equipment used during production. A successful engineering run is invaluable to ensure quality in subsequent current good manufacturing practice (cGMP) and packaging runs.

    The engineering run is carried out on the commercial equipment train to gather data (including stability) and perform filling and packaging line trials. It also provides the processing data that can then be used in the scale up and validation steps to follow.

    Since collecting this data is critical, at least one engineering run should be completed, with the risk of additional costs and delays if this step is neglected.

    Scale up
    Scale up is the process by which batch sizes are increased from feasibility or engineering batch scale to commercial scale, usually representing a 5-10x increase in volume.
    Knowledge should be gained on two factors during this process: acquiring the chemistry and process knowledge to be able to effectively manage the formulation at commercial scale and developing a strategy to manage production and material costs.

    Project and program management
    An experienced project and program management team is an essential element in ensuring that challenges at the later stages of the process can be managed. Working together with sponsors has allowed our team at Bora to navigate hurdles that have arisen once a product has been submitted for approval to regulators.

    In one example, Bora worked with a long-standing client on a complex modified-release capsule product with several different components. Once the product was submitted to the U.S. FDA for approval, an issue arose regarding capsule filling equipment not being able to measure individual component weights, which was deemed by the agency to be a necessary control parameter. The team at Bora organized a joint project group with the partner to develop potential solutions, resulting in a change to a more suitable capsule filling machine. The FDA agreed to the changes and the product was successfully approved and commercialized.

    Key takeaways
    We’ve provided a lot of information, but ultimately the three takeaway points to ensure a successful tech transfer are:
    • Communicate openly and frequently from the outset through planned meetings with solid record keeping
    • Establish working processes and take time with the initial planning stages
    • Maintain a partnership based on trust and respect to ensure success with each transfer and program 

    References
    1. https://www.pharmavoice.com/digital-edition/january-2020/#1


    Tom Chang is the President of Bora Pharmaceuticals Laboratory Co. Ltd. and oversees two manufacturing sites for Bora Pharmaceuticals. He has over 27 years’ experience in the pharmaceutical industry and over 14 years’ experience as a site general manager for multinational companies including Wyeth, Pfizer, and Impax. He has extensive knowledge and experience in global supply chain and operational management. Tom has outstanding leadership and professional skills and seeks to provide the highest quality products for his customers. He is a critical part of the leadership team at Bora Pharmaceuticals, a premier international CGMP CDMO specializing in oral solid dosage, liquids (solutions, suspensions, and nasal sprays), and semi-solids (creams and gels) pharmaceutical Rx and OTC products for late-phase clinical through commercial manufacturing and packaging. For more information visit: info@bora-corp.com
    Suggested For You
    Bora Pharmaceuticals Bora Pharmaceuticals
    Taros Chemicals GmbH & Co. KG Taros Chemicals GmbH & Co. KG
    W. R. Grace FCMS W. R. Grace FCMS
    ViscoTec America Inc. ViscoTec America Inc.
    PCI Pharma Services PCI Pharma Services
    Sekisui Sekisui
    PCI Synthesis PCI Synthesis
    Seqens CDMO North America Seqens CDMO North America
    AltheaDx Expands Commercial Leadership Team AltheaDx Expands Commercial Leadership Team
    Embedding Your Drug Strategy Within a Solid Foundation for Success Embedding Your Drug Strategy Within a Solid Foundation for Success
    21st Annual Contracting & Outsourcing Conference & Exhibition 21st Annual Contracting & Outsourcing Conference & Exhibition
    Corealis Pharma Corealis Pharma
    Lonza Capsules and Health Ingredients Lonza Capsules and Health Ingredients
    Catalent Pharma Solutions Catalent Pharma Solutions
    CureVac and Wacker Sign Contract for Manufacturing of Covid-19 Vaccine Candidate CureVac and Wacker Sign Contract for Manufacturing of Covid-19 Vaccine Candidate

    Related Content

    • Bora Pharmaceuticals

      Bora Pharmaceuticals

      ...
      Lonnie Barish, VP, Business Development 03.09.22

    • Taros Chemicals GmbH & Co. KG

      ...
      Dimitrios Tzalis, Manager Executive Projects 12.07.21

    • W. R. Grace FCMS

      W. R. Grace FCMS

      ...
      Stella Ip, Director Marketing Health and Life Sciences 11.23.21


    • ViscoTec America Inc.

      ...
      Melanie Hintereder, Marketing 11.05.21

    • Drug Development
      PCI Pharma Services

      PCI Pharma Services

      ...
      Jessica Kloster, Marketing Manager 10.20.21

      Trending
      • Catalyst Biosciences Sells Complement Portfolio To Vertex Pharmaceuticals | Contract Pharma
      • Hanmi Fine Chemical Launches CDMO Business | Contract Pharma
      • CureVac, MyNEO Partner On Antigen Targets For MRNA-Cancer Vax Development | Contract Pharma
      • Mirum Pharmaceuticals Acquires San Diego-based Satiogen | Contract Pharma
      • Insmed Appoints Drayton Wise As Chief Commercial Officer | Contract Pharma
      Breaking News
      • iECURE Enters Agreement with Center for Breakthrough Medicines
      • CPDC Enters Clinical Manufacturing Deal with CellBion
      • Olon to Build New R&D Center in Italy
      • Hanmi Fine Chemical Launches CDMO Business
      • DFE Pharma Opens India CoE for Fast-Track Formulation Services
      View Breaking News >
      CURRENT ISSUE

      May 2022

      • Sustainability and the Biopharma Industry
      • Contract Manufacturing During COVID
      • Orphan Drugs in the United States
      • CEO Spotlight: Peter DeYoung
      • CEO Spotlight: Darren Head
      • Advanced Therapy Packaging Trends
      • Advanced Therapy Manufacturing
      • Sustainability: A New Threat or Opportunity for CDMOs?
      • SARS-CoV-2 R&D

      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

      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Alkemist Labs Announces Alkemist Assured Seal and Next Generation Transparency Reports
      GC Rieber Foundations Expand Philanthropic Efforts
      Coatings World

      Latest Breaking News From Coatings World

      Nippon Paint Automotive Americas Appoints Robert Angart CEO and President
      Sustainability, Economy are Focus of BCF’s Annual Conference
      Demand for Rhino Shield Increases
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      MPO's Most-Read Stories This Week—May 28
      New Breast Implant Surgery Guidelines to Enhance Patient Safety
      Rhythm Management Group Debuts RhythmSynergy Tech Platform
      Contract Pharma

      Latest Breaking News From Contract Pharma

      iECURE Enters Agreement with Center for Breakthrough Medicines
      CPDC Enters Clinical Manufacturing Deal with CellBion
      Olon to Build New R&D Center in Italy
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      K-Beauty Brand Siita Shares Plastic Decomposition Technology with the Beauty Industry
      Shellworks Raises $6.2 Million in Seed Funding
      Ulta Beauty Reports Record First Quarter 2022 Results
      Happi

      Latest Breaking News From Happi

      Global Skincare Treatment Devices Market Expected to Grow at Over 11.5% CAGR Rate Through 2028
      Honeywell Addresses Critical Issues Such as Sustainability, Workforce Training and Digitalization
      Monat Global Wins Four Stevie Awards in the 20th Annual American Business Awards
      Ink World

      Latest Breaking News From Ink World

      Weekly Recap: Flint Group, New Inks from Siegwerk and Zeller+Gmelin Lead This Week’s News
      Orion to Finish Gas Black Expansion in Germany by Early 2023
      Richard Childress Racing Shows Off New Wraps for 2022 NASCAR Season
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      UPM Raflatac accelerates label growth with acquisition
      Labelexpo Asia 2022 postponed
      Teklynx software helps Top Clean Injection validate labels
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Rael Raises $35M in Series B Funding
      Schobertechnologies Offers Rotary Web-fed Converting Solutions
      Thorne Relaunches Gut Health Test with Microbiome Wipe
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      ODT's Most-Read Stories This Week—May 28
      Toetal Solutions Raises $1.02 Million in New Financing
      ManaMed's ManaSport Wearable Ultrasound Earns FDA Nod
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Weekly Recap: OPV’s Future, Graphene Flagship and Japan Display Top This Week’s Stories
      SEMI Foundation Receives $1.5 Million Grant to Bolster Michigan’s Semiconductor Talent Pipeline
      onsemi Recognized by Fortune 500 for Its Transformation Journey

      Copyright © 2022 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