• 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
    Alcami

    Emergent BioSolutions

    Cytovance Biologics

    PCI Pharma Services

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

    Adare Pharma Solutions

    Syngene

    Baxter BioPharma Solutions

    Emergent BioSolutions
    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
    India Report

    Highly Potent Expansions

    CDMOs see HPAPI demand rising

    Highly Potent Expansions
    Related CONTENT
    • Inhalation CDMO Vectura Expands HPAPI Capabilities
    • Piramal Invests $32M to Expand Michigan Facility
    • Piramal Pharma Solutions
    • Mogene
    • Softweb Solutions
    S. Harachand, Contributing Editor09.16.19
    Piramal Pharma Solutions recently announced that the Indian company has bolstered its highly potent API (HPAPI) capacity at its Riverview, MI manufacturing facility.

    Investing about $10 million, the contract development and manufacturing organization (CDMO) has added two kilo labs as well as quality control and analysis labs. The factory, which makes HPAPIs with low occupational exposure levels (OELs) is now capable of producing highly potent compounds with OELs down to 1mcg/m3. The state-of-the-art site is designed with the required engineering controls and containment solutions to handle HPAPIs with OELs 1mcg/m3 and as low as 20ng/m3 at scales ranging from grams to 250 kilos. The new wing can manufacture materials at kilo lab scales with lots of 5 kilos.

    The enhanced capability opens the site up to a new base of customers, including the antibody drug conjugate (ADC) market, according to Vince Ammoscato, vice president and Riverview site head.

    ADCs comprise an antibody conjugated to a cytotoxic drug. The cancer-killing compounds are attached to the antibodies with linker technology. These innovative class of drugs combines the specificity of monoclonal antibodies for antigen-expressing tumor cells with small molecule anti-cancer drugs. Once the antibody is bound to the tumor, the chemical linker degrades, releasing the drug into the tumor. Since ADCs enable efficient delivery of cytotoxic drugs directly to targeted cells, they avoid potential damage to the normal cells—one of the major drawbacks associated with conventional chemotherapy.

    Nearly half a dozen ADCs have already been approved by the FDA for commercial use and over 50 such products are currently undergoing clinical trials for various indications, such as refractory Hodgkin lymphoma, glioblastoma, small cell lung cancer, breast cancer, and ovarian cancer.

    The cytotoxic “payloads” in ADCs are, usually, HPAPIs. Piramal offers a fully integrated solution for the ADC market—from proof-of-concept studies to conjugation development, clinical and commercial ADC GMP batch manufacturing and fill/finish.

    The Riverview facility is equipped to develop HPAPI payloads and linkers. Then they are sent to the company’s Scotland site for the antibody conjugation, then back to Lexington, KY for sterile fill and finish, according to Ammoscato. This lends a strategic advantage for the CDMO. The company is planning more expansions in the coming days.

    The need for creating additional manufacturing capacities for HPAPIs is driven by increasing demands for these compounds.

    The global HPAPI market is expected to expand at a compound annual growth rate (CAGR) of 8.7% to $26.84 billion in 2023 from $17.72 billion in 2018, forecasts a report by Markets and Markets. The rate of growth of HPAPIs can be even higher to the tune of 10.3% per annum touching $34.8 billion by the year 2025, estimates Grand View Research.

    Projections of the market value of HPAPIs vary. But the share of highly potent drugs in development is obviously on the rise. Treatments against cancer lead the global pharmaceuticals pipeline. And the oncology segment is where the largest proportion of HPAPIs are used in, reports indicate.

    There are not many players around who have mastered the art and science of making HPAPIs. It is fewer so when it comes to the contract manufacturing space. This is because the production of HPAPIs involves complex processes and containment facilities requiring highly skilled manpower. Extensive capital investments are needed for the development of such a cGMP facility.

    Captive manufacturing occupies the lion’s share in the HPAPI market as innovative companies prefer to maintain them in-house.

    The trend is changing now. While resource constraints to build high containment facilities compel small and medium companies to look for contract service providers, larger firms prefer outsourcing in earlier development stages.

    Also, reports say that some of the firms with HPAPI capacity are divesting their facilities in favor of outsourcing to CDMOs with integrated capabilities.

    All types of companies see the value of developing strategic relationships with integrated CDMOs, according to Stuart Needleman, chief commercial officer, PPS. Sponsor companies are challenged by limited budgets and have to work smarter to remain competitive and outsourcing integrated services is a way to advance multiple candidates faster.

    Pfizer, Novartis, Sanofi, Roche, Bristol-Myers Squibb, Boehringer Ingelheim, Teva, Eli Lilly, Merck, AbbVie, Mylan and Bayer are among the leading producers.

    The emerging markets of India and China are expected to boost the demand for HPAPIs in the forecast period, according to Grand View.

    Anticipating greater demand, Piramal is planning to make the Riverview facility operational round the clock, 24 hours a day, instead of the current twelve hours a day, seven days a week. The company bought the Ash Stevens operations in 2016 for $53 million plus milestone payments.


    S. Harachand
    Contributing Editor

    S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
    Related Searches
    • china
    • lilly
    • production
    • high containment
    Suggested For You
    Inhalation CDMO Vectura Expands HPAPI Capabilities Inhalation CDMO Vectura Expands HPAPI Capabilities
    Piramal Invests $32M to Expand Michigan Facility Piramal Invests $32M to Expand Michigan Facility
    Piramal Pharma Solutions Piramal Pharma Solutions
    Mogene Mogene
    Softweb Solutions Softweb Solutions
    Vetio Animal Health Vetio Animal Health
    High Containment & Cost Savings with Single Use Isolator Technology High Containment & Cost Savings with Single Use Isolator Technology
    API to ADC: A Journey Through High Potency API to ADC: A Journey Through High Potency
    Lilly Receives FDA Approval for Ankylosing Spondylitis Treatment Lilly Receives FDA Approval for Ankylosing Spondylitis Treatment
    Pfizer Invests $500M in Gene Therapy Facility Pfizer Invests $500M in Gene Therapy Facility
     Lilly Announces Leadership Changes Lilly Announces Leadership Changes
    Astellas Appoints SVP and Head Clinical and Research QA Astellas Appoints SVP and Head Clinical and Research QA
    Syapse, Pfizer in Oncology Precision Medicine Pact Syapse, Pfizer in Oncology Precision Medicine Pact
    09	Lilly 09 Lilly
    01	Pfizer, Inc. 01 Pfizer, Inc.

    Related India Report

    • Injectables Firms Expand Capacity

      Injectables Firms Expand Capacity

      CDMOs see steriles demand grow.
      S. Harachand, Contributing Editor 11.17.20

    • Supply Chain Woes Vex Markets

      Supply Chain Woes Vex Markets

      Indian players ramp up chloroquine production
      S. Harachand, Contributing Editor 09.09.20

    • HCQ Comes Center Stage

      HCQ Comes Center Stage

      Indian players ramp up chloroquine production
      S. Harachand, Contributing Editor 05.05.20


    • Supply Chain
      Oral Solids Makers Face Corona Heat

      Oral Solids Makers Face Corona Heat

      CDMOs fear supply disruptions, price increases.
      S. Harachand, Contributing Editor 03.04.20

    • Biosimilars
      The Similar Mantra

      The Similar Mantra

      Early birds bet big on biosimilars.
      S. Harachand, Contributing Editor 01.28.20

    • APIs
      India to Track API Packs

      India to Track API Packs

      India is mulling a shakeup in the regulations governing the distribution of pharmaceutical products.
      S. Harachand, Contributing Editor 11.20.19


    • R&D
      Indian Firms Ramp Up R&D

      Indian Firms Ramp Up R&D

      Accelerating on research spend.
      S. Harachand, Contributing Editor 10.15.19

    • The Orphan Promise

      The Orphan Promise

      New policy on rare disease treatments likely soon
      S. Harachand, Contributing Editor 06.13.19

    • Biologics, Proteins, Vaccines
      Ebullient Bio CMOs

      Ebullient Bio CMOs

      Firms see rich dividends from biosimilars
      S. Harachand, Contributing Editor 05.07.19


    • R&D
      Strategic Discovery

      Strategic Discovery

      CROs top offerings with biology skills.
      S. Harachand , Contributing Editor 10.10.18

    • HPAPI Outsourcing Likely to Gain Traction

      HPAPI Outsourcing Likely to Gain Traction

      A number of highly potent drugs will soon fall into the generic domain
      S. Harachand, Contributing Editor 09.11.18

    • Packaging Majors Expand Base in India

      Packaging Majors Expand Base in India

      India’s pharma packaging market is growing at a faster pace than other world markets
      S. Harachand, Contributing Editor 03.09.18


    • Acquisition Spree

      Acquisition Spree

      Indian firms topped the list of aggressive bidders even as the frenzy of deal making in the global generics space passes into
      S. Harachand, Contributing Editor 01.30.18

    • Drug Delivery
      Growing NDDS Portfolios

      Growing NDDS Portfolios

      Generic drugs on novel delivery platforms
      S. Harachand, Contributing Editor 10.11.17

    • Supply Chain
      Marketing Code Round The Corner

      Marketing Code Round The Corner

      Proposal to limit giveaways; offenders face product ban
      S. Harachand, Contributing Editor 09.01.17

    Trending
    • Catalent Acquires Acorda’s INBRIJA Manufacturing Operations
    • Fujifilm To Invest $2B In US Manufacturing Site
    • Baxter, Novavax Ink Sterile Manufacturing Agreement
    • Precision Medicine Group Acquires Project Farma
    • Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz
    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

    Amyris Named a Top Social & Environmental Impact Company
    L'Oréal Bans Animal Hair in Brushes
    Ashland Launches Antaron ECo Gel
    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