• 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
    Vector Partners Limited

    IDT Biologika

    CMC Pharmaceuticals

    Baxter BioPharma Solutions

    Biosynth Carbosynth
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Vector Partners Limited

    IDT Biologika

    CMC Pharmaceuticals

    Baxter BioPharma Solutions

    Biosynth Carbosynth
    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
    Breaking News

    Alcami Extends Workbench Laboratory Services Program

    To support the ongoing manufacturing and development of ZILRETTA for Flexion Therapeutics

    Alcami Extends Workbench Laboratory Services Program
    Related CONTENT
    • Alcami
    • Mogene
    • Softweb Solutions
    • Semi-Solids: A Regulatory Perspective
    • Alcami Acquired by Private Equity Firm
    06.13.18
    Alcami Corporation has announced the expanded deployment of its Extended Workbench laboratory services program to support the ongoing manufacturing and development of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension). 
     
    ZILRETTA is the first FDA approved product from Flexion Therapeutics. Flexion utilized Alcami's Extended Workbench to support ZILRETTA from Phase 2 clinical trials through commercial launch and is using the program for the release and stability testing of commercial batches.

    Alcami's Extended Workbench is a full-time equivalent (FTE) comprehensive service program customized to a client's specific project. It dedicates Alcami staff to a particular project, granting clients additional flexibility, freedom, and consistent control over their outsourced laboratory needs. Extended Workbench can vary in size, management type, and scope, and can be effective across any pharmaceutical platform. The fixed-cost service can meet every laboratory necessity, from method development and validation to full quality control support.

    "Our versatile Extended Workbench solution was an excellent fit for our partners at Flexion, whose accelerated timeline, robust clinical trial program, and specific testing requirements mandated dedicated laboratory resources to get their product to market," said Alcami chief commercial officer, Syed T. Husain. "It was a privilege to have collaborated with Flexion, leading to the approval of ZILRETTA, and we are pleased our Extended Workbench will continue to support their product.”
     
    "For the past four years, Alcami has been one of our most trusted collaborators," said Mike Clayman, M.D., president and chief executive officer of Flexion. "They have been able to both respond to and anticipate our needs as Flexion has transitioned into a commercial organization, and we look forward to their ongoing support.”

    ZILRETTA is the first and only FDA-approved extended-release intra-articular therapy for patients confronting OA-related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide – a commonly administered, short-acting corticosteroid – with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief over 12 weeks.

    Alcami began work on ZILRETTA in the fall of 2014. The company helped Flexion meet demanding requirements from the FDA during the review of the New Drug Application, which ultimately resulted in the U.S. approval of ZILRETTA for the treatment of OA-related knee pain on October 6, 2017. The product was officially launched nationwide in late November of 2017.

     
    Related Searches
    • it
    • Development
    • Validation
    • fda
    Suggested For You
    Alcami Alcami
    Mogene Mogene
    Softweb Solutions Softweb Solutions
    Semi-Solids: A Regulatory Perspective Semi-Solids: A Regulatory Perspective
    Alcami Acquired by Private Equity Firm Alcami Acquired by Private Equity Firm
    Flexion Therapeutics Appoints CFO Flexion Therapeutics Appoints CFO
    Alcami Donates $10K to TROSA Alcami Donates $10K to TROSA
    Drug Safety Update Drug Safety Update
    HHS 2019 Budget Proposal: Key Priorities Impacting Pharma HHS 2019 Budget Proposal: Key Priorities Impacting Pharma
    Alcami Opens Office in Cambridge, MA Alcami Opens Office in Cambridge, MA
    Cellenkos Completes FDA Registration of GMP Mfg. Facility Cellenkos Completes FDA Registration of GMP Mfg. Facility
    Pii Receives 7 Market Approvals from FDA in 2017 Pii Receives 7 Market Approvals from FDA in 2017
    An Interactive Global Map of Pharma Manufacturing Sites An Interactive Global Map of Pharma Manufacturing Sites
    Sobi Receives IND Acceptance from FDA Sobi Receives IND Acceptance from FDA
    Thermo Fisher Designs Manufacturing Site for Flexion Thermo Fisher Designs Manufacturing Site for Flexion

    Related Content

    • Alcami

      Alcami

      ...
      Michael Walsh, Marketing Manager 12.01.20

    • Mogene

      ...
      Craig Morley, CEO 11.17.20

    • Softweb Solutions

      ...
      Micheal Jury, Marketing Manager 09.23.20


    • Regulatory Affairs | Solid Dosage/Creams/Ointments
      Semi-Solids: A Regulatory Perspective

      Semi-Solids: A Regulatory Perspective

      Compliance of semi-solid dosages to FDA Stage III Continuous Process Verification.
      José L. Toro, Ph.D., Lachman Consultants 06.12.18

    • Breaking News | Industry News
      Alcami Acquired by Private Equity Firm

      Alcami Acquired by Private Equity Firm

      The CDMO's management team will remain in place
      06.01.18

      Trending
      • How Can Automation Optimize Immunohistochemistry? | Contract Pharma
      • Catalyst Biosciences Sells Complement Portfolio To Vertex Pharmaceuticals | Contract Pharma
      • Corealis CDMO Completes Deal With ArchiMed | Contract Pharma
      • Mirum Pharmaceuticals Acquires San Diego-based Satiogen | Contract Pharma
      • CureVac, MyNEO Partner On Antigen Targets For MRNA-Cancer Vax Development | 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

      Sustainability, Economy are Focus of BCF’s Annual Conference
      Demand for Rhino Shield Increases
      ICP Receives ASC Innovation Award for Spray Foam That Meets Changing Environmental Regulations
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      New Breast Implant Surgery Guidelines to Enhance Patient Safety
      Rhythm Management Group Debuts RhythmSynergy Tech Platform
      FDA Approves Trial Completion for Virtual Incision's MIRA 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

      Honeywell Addresses Critical Issues Such as Sustainability, Workforce Training and Digitalization
      Monat Global Wins Four Stevie Awards in the 20th Annual American Business Awards
      Coty Expands Vegan Beauty Portfolio With New Rimmel Mascara
      Ink World

      Latest Breaking News From Ink World

      Zeller+Gmelin Honored as Berry Global’s 2021 Ink Supplier of the Year
      Paul N. Gardner USA Introduces New PosiTector GLS Gloss Meter
      UK-Based Caps Cases Installs World’s First EFI Nozomi 14000 LED Digital Corrugated Press
      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

      Toetal Solutions Raises $1.02 Million in New Financing
      ManaMed's ManaSport Wearable Ultrasound Earns FDA Nod
      Ekso Bionics Names Jerome Wong as Interim CFO
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      onsemi Recognized by Fortune 500 for Its Transformation Journey
      LG Display Presents AI-Driven NFT Artwork on Transparent OLED
      Joe Stockunas Joins SEMI as Americas President

      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