• 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
    High Drug Loading Amorphous Solid Dispersions

    Parenteral Drug Delivery Trends

    Selecting the Right Outsourcing Model for Emerging Biotech

    Inhaled Drug Delivery Technology

    The Future of Biologics: Accelerating Production, Reducing Costs
    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
    Altasciences Contributes to Vibegron Approval

    Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement

    Pfizer Selects Seven Bridges to Support RNA Sequencing Data

    ACG Launches ACG Laboratories

    Glatt and Aprecia Enter 3D-Printing Collaboration
    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

    Why Increasing Solubility May Not Improve Bioavailability - In Vitro Predictions

    ACG Launches ACG Laboratories

    Glatt and Aprecia Enter 3D-Printing Collaboration

    Catalent Acquires Delphi Genetics

    Almac Group Completes $7M R&D Center
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Centrient Pharmaceuticals to Acquire Astral SteriTech

    Seasonal Vaccine Manufacturing

    PwC Joins Medicines Manufacturing Innovation Centre

    AARDEX Group Partners with Pill Connect

    Phillips-Medsize and Subcuject Collaborate
    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

    Altasciences Contributes to Vibegron Approval

    Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement

    Why Increasing Solubility May Not Improve Bioavailability - In Vitro Predictions

    Pfizer Selects Seven Bridges to Support RNA Sequencing Data

    ACG Launches ACG Laboratories
    Filtration & Purification
    GMPs/GCPs
    Inspections
    QA/QC
    Regulatory Affairs
    Validation

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

    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
    Companies
    Categories
    Corporate Capabilities
    Add New Company
    Contract Service Directory Companies
    PCI Pharma Services

    Alcami

    Syngene

    Adare Pharma Solutions

    Aphena Pharma Solutions
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    test company saurabh

    Almac Group

    Reed-Lane

    Alcami

    Baxter BioPharma 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

    DCAT Week '17 Q&A: API Market Trends

    Minzhang Chen of STA Pharmaceutical discusses the company’s business model, initiatives, and trends driving API development

    Related CONTENT
    • Tubulis, WuXi Biologics and WuXi STA Form Strategic Pact
    • Mogene
    • WuXi AppTec
    • Vetio Animal Health
    • Frontida BioPharm Launches Expansion Efforts
    Kristin Brooks, Contract Pharma03.27.17
    STA Pharmaceutical, the small molecule branch of WuXi AppTec, develops NCEs (APIs) for pharma and biopharma companies, providing early and late phase development and manufacture, as well as commercial manufacture. The company only develops patented drugs, and while it is not particularly well known, is currently working on more than 100 APIs (200 inclusive of intermediates). 
     
    Contract Pharma spoke with Minzhang Chen, chief executive officer at STA Pharmaceutical to learn more about the company and API market trends. --KB
     
    Contract Pharma: Please provide a brief background on STA Pharmaceutical and its services
     
    Minzhang Chen: STA is a subsidiary of WuXi AppTec providing a small molecule pharmaceutical development and manufacturing platform serving the life sciences industry. In the past few years, the company has grown very quickly. In 2016, we opened a 39-acre fully integrated process R&D and API manufacturing facility in Changzhou, China as well as a facility to support preclinical and early phase API Process R&D and cGMP production in San Diego, CA. These add to STA’s existing FDA approved facility in Jinshan (Shanghai) and an R&D site in Shanghai. Our customer base is roughly made-up of around 90% pharma and biotech customers from the U.S. and Europe with 10% Chinese innovative drug development companies. Overall in 2016, STA accomplished more than 500 projects including 150 New Chemical Entity APIs under clinical development and more than 30 projects in Phase III or commercial production.
     
    Our integrated Changzhou site is designed to advance our client’s APIs and advanced intermediates through preclinical and clinical development to global commercial launch. Upon completion, the site will employ more than 500 scientists and will add nine pilot and commercial plants with more than 1,500 m3 of reactor volume in total.  The plants will fulfill our customer’s pipeline needs, with many of the programs now entering process validation and commercialization stage, requiring us to add production capacity. In fact, since the Changzhou site opened less than a year ago, we have more than 40 active pharma customers running programs at this site, with 60 APIs and/or intermediates supporting various clinical programs, and one New Chemical Entity API already in commercial production at this site.
     
    CP: What’s the company’s business model?  How does STA set itself apart from other firms?
     
    MC: STA has taken the approach of working with very large numbers of pharma and biotech clients earlier in the development and R&D cycle, and staying with these partners through to commercialization. Unlike some of the other CDMOs, who try to pick up work at a later stage, our strategy is to maintain a huge pipeline of early clinical stage clients, with a view to progressing these into commercial production. So, rather than trying to back-integrate, we are helping our customers from the inception of their product through to launch. This approach has led to a steady pipeline of work entering into commercial production and also means we handled more projects in the R&D stage than other CDMOs.
     
    In the last few years, our commercial manufacturing capacity need has been rising and we are now investing heavily in new manufacturing facilities to meet the demand. Another difference in our strategy compared to many of the other CDMOs, is that we are investing heavily in our own world class facilities rather than through acquisition – which, I think, is a testament to the company’s strength and confidence, new business pipeline and ability to move a large number of development projects into commercial production.
     
    CP: What are some initiatives currently underway?
     
    MC: STA has taken many initiatives in recent years with the aim of becoming an industry leader in “Green Chemistry”.  Our biocatalysis center now owns an in-house library of more than 500 commercial enzymes available for rapid screening.  The team successfully manufactured over 50 programs ranging from kilo to metric ton scale under cGMP using this technology.  We also built a comprehensive flow chemistry platform. To date, we’re fully equipped with various laboratory and plant scale flow chemistry systems to handle some of the most challenging or hazardous chemistries such as photochemistry, ozonolysis, cross-coupling reactions (Negishi and Kumada), reactions with sodium azide, just to name a few examples.  
     
    One of the lesser-reported activities we strive to undertake at STA is to constantly improve the effectiveness of our processes, improve efficiency and reduce waste. Company-wide, in the last several years we have reduced our overall PMI (Process Mass Intensity) index by around 25% each year, and we are targeting another 20% in 2017 – which really would be quite remarkable. It’s a challenge we set for our chemists and manufacturing teams to design “greener” processes for new programs and keep improving the processes we have already developed.
     
     
    CP: What is the company’s strategy for the next five years?
     
    MC: The next five years is going to be a key period for both STA and the wider industry. We are going to continue to invest in enhancing the capability and capacity of our service offerings. We’ve seen increased consolidation among CDMOs, and the market is clearly moving towards providers who can offer a wide range of technical capabilities. Our core strength has been our R&D teams but increasingly we foresee a much greater volume of commercial production at the expanded STA sites. We expect to grow at over a double-digit pace for the next five years as the company fills this capacity.
     
    CP: What market trends are driving API development today?
     
    MC: There are a couple of notable major trends. First, the types of molecules being developed are becoming far more complicated, requiring more advanced chemistries and technologies. This is presenting good opportunities for STA as both biotech and pharma customers need experienced R&D and manufacturing teams working closely together that can deliver these new drug targets faster. CDMOs must adapt to the new paradigms in the market – speed and flexibility will be a major factor in those that fail or succeed. We also saw tightened regulatory oversight from around the globe which is reflected by the increased number of Warning Letters issued by FDA as well as the regulatory “push backs” on the Starting Materials definitions.   
     
     
    CP: Are there certain regulatory/quality control issues the industry continues to face?
     
    MC: What we are seeing is that customers are far more closely attuned to working with CDMOs with the highest standards of manufacturing quality and control. While cost continues to be a factor on decisions, the ability to demonstrate a proven track record of global regulatory approvals, coupled with experience in QbD and continuous improvement, are an essential component of working with an outsourced partner.
     
    At STA, we have an exemplary regulatory record. We’re the first CMC platform in China that passed FDA inspection for new chemical entities. Our Jinshan API facility is also the first contract manufacturing organization in China that is approved to supply APIs and GMP intermediates for branded commercial drugs by regulatory agencies in U.S., Canada, EU, Switzerland, China, Japan, Australia, and New Zealand. Our facilities have also successfully passed quality audits by more than 100 clients worldwide since 2004. Regulatory and quality excellence remain a fundamental part of our growth strategy.
     


     
    Minzhang Chen, CEO at STA Pharmaceutical, a WuXi AppTec Company
    Dr. Chen joined WuXi AppTec in 2008 and currently serves as CEO of STA, the small molecule process development and manufacturing subsidiary of WuXi AppTec. Under his leadership, STA has grown over the past seven years from an early phase process research focused organization to a world leading contract development and manufacturing organization for process R&D and API manufacturing from preclinical to commercial.
     
    Prior to joining WuXi, he served as Director of Technical Operations at Vertex Pharmaceuticals where he led a team who successfully supported the process R&D, API contract manufacturing and commercialization of Incivek. He also worked as a Principle Scientist at Schering-Plough Research Institute before joining Vertex.
    Related Searches
    • Pharma
    • flow chemistry
    • Validation
    • contract manufacturing organization
    Suggested For You
    Tubulis, WuXi Biologics and WuXi STA Form Strategic Pact Tubulis, WuXi Biologics and WuXi STA Form Strategic Pact
    Mogene Mogene
    WuXi AppTec WuXi AppTec
    Vetio Animal Health Vetio Animal Health
    Frontida BioPharm Launches Expansion Efforts Frontida BioPharm Launches Expansion Efforts
    So You Think You Know  All About Excipients? So You Think You Know All About Excipients?
    The FDA and Metrics The FDA and Metrics
    CROs & Next-Gen  Drug Development CROs & Next-Gen Drug Development
    Injectable Drug Delivery Trends Injectable Drug Delivery Trends
    Trump Picks New FDA Commish Trump Picks New FDA Commish
    Reality and Un-Reality:  Continuous Processing in Pharmaceutical Manufacturing Reality and Un-Reality: Continuous Processing in Pharmaceutical Manufacturing
    Newsmakers: Peter Soelkner Newsmakers: Peter Soelkner
    Generic Drug Trends Generic Drug Trends
    Whither Washington? Whither Washington?
    LSNE Completes Two FDA Inspections LSNE Completes Two FDA Inspections

    Related Online Exclusives

    • Drug Delivery
      Aerosol Delivery Devices Market

      Aerosol Delivery Devices Market

      Advantages over conventional drug delivery devices, rise in prevalence of COPD and asthma drive the growth of the global aerosol delivery devices market.
      Allied Market Research 02.16.21

    • Biologics, Proteins, Vaccines | Clinical Trials
      Inside a Vaccine Trial

      Inside a Vaccine Trial

      Dr. Murphy of ICON, provider of clinical services to Pfizer/BioNTech’s COVID vaccine program, discusses what it takes to conduct a vaccine trial of this scale.
      Kristin Brooks, Managing Editor 02.05.21

    • Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development
      The Future of Vaccines and Biologics

      The Future of Vaccines and Biologics

      Dr. Linda Marbán of Capricor Therapeutics discusses the advances in responding to infectious diseases.
      Kristin Brooks, Managing Editor, Contract Pharma 02.04.21


    • Clinical Trials | Information Technology
      The State of Clinical Trial Technology

      The State of Clinical Trial Technology

      Blake Adams of Florence discusses key report findings and the clinical trial software used to support Pfizer’s global COVID-19 vaccine study.
      Kristin Brooks, Contract Pharma 01.26.21

    • Analytical Services | Laboratory Testing
      Improving Product Profitability

      Improving Product Profitability

      Using PAT/QbD/CM as tools to increase profitability of products.
      Emil Ciurczak, Contributing Editor 01.21.21

    • 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


    • Excipients
      Pharmaceutical Excipients Market Poised for Growth

      Pharmaceutical Excipients Market Poised for Growth

      The global pharmaceutical excipients market is estimated to surpass $11,944.6 million by 2027.
      Contract Pharma Staff 11.03.20

    • cGMP Manufacture | Fill/Finish | Scale-up/Technology Transfer
      Ramping Up COVID-19 Vaccine Fill and Finish Capacity

      Ramping Up COVID-19 Vaccine Fill and Finish Capacity

      As a partner to the U.S. Government, GRAM's newest facility was designed to increase large-scale fill and finish capacity with room to expand as demand grows.
      Kristin Brooks, Contract Pharma 11.03.20

    • 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


    • 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

    • 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

    Trending
    • Catalent Acquires Delphi Genetics
    • Inside A Vaccine Trial
    • Wavelength Pharmaceuticals Acquires Majority Stake In Vanamali Organics
    • Century Therapeutics Significantly Expands Capabilities
    • ICON Acquires Medpass
    Breaking News
    • Altasciences Contributes to Vibegron Approval
    • Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement
    • Pfizer Selects Seven Bridges to Support RNA Sequencing Data
    • ACG Launches ACG Laboratories
    • Glatt and Aprecia Enter 3D-Printing Collaboration
    View Breaking News >
    CURRENT ISSUE

    January/February 2021

    • High Drug Loading Amorphous Solid Dispersions
    • Parenteral Drug Delivery Trends
    • Selecting the Right Outsourcing Model for Emerging Biotech
    • Inhaled Drug Delivery Technology
    • The Future of Biologics: Accelerating Production, Reducing Costs
    • Business Intelligence For (and From) the Lab
    • Communicating Your Contracting Priorities to Your Drug Company Customers
    • COVID-19 Impact Report
    • The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
    • 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 Trial Finds Metabolic Benefits for Polyphenols Formula
    JRF Technology Debuts Elderberry Oral Film Strip
    Danone Adds to Plant-Based Portfolio with Acquisition of Follow Your Heart Brand
    Coatings World

    Latest Breaking News From Coatings World

    Hempel Launches Sustainability Framework: Futureproof
    ChemQuest Hires Rich Gibson
    New Increase in Kynar Fluoropolymer Capacities at Arkema's Chinese Site
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    Terumo to Purchase Predictive Analytics Firm Health Outcomes Sciences
    Abiomed Leader Michael Minogue Named AdvaMed Board Chairman
    TransEnterix Changes Name to Asensus Surgical
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Altasciences Contributes to Vibegron Approval
    Cyprium, Sentynl Therapeutics Ink Asset Purchase Agreement
    Pfizer Selects Seven Bridges to Support RNA Sequencing Data
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Madison Reed Raises $52 Million in Financing Round
    The Estée Lauder Companies Closes Becca Cosmetics
    Afro Sheen Launches New Brand Initiatives
    Happi

    Latest Breaking News From Happi

    PBA Opposes House Bill 2325 in West Virginia
    J.R. Watkins Tackles Pain with New Lines
    RB Launches Vanish Miracle
    Ink World

    Latest Breaking News From Ink World

    Etiflex Enters New Markets with Nilpeter FA-22 Installation
    Hydrocarbon Solvents Market to Surpass $8.1 Billion by 2030
    Lowe-Martin Adds 2 KODAK NEXFINITY Digital Presses
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Eaglewood Technologies debuts new anilox cleaning system
    INX International and VerifyMe sign supply agreement
    Soma partners with DTM Flexo Services
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    H&V Announces Price Increase
    Fiber Bond VE3 Technology Inactivates SARS-CoV-2 in HVAC Filtration Systems
    Citizens Provides $325 Million Senior Credit Facility to Nice-Pak
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    NuVasive Nabs Simplify Medical for $150M
    SeaSpine Begins Limited Launch of WaveForm TA (TLIF Articulating) 3D-Printed Interbody
    Nexus Spine Implants for Use in Spinal Surgeries Become Available
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Comercial Kywi Improves Customer Service, Front-Store Operations with Zebra Mobile Solution
    Global Printed Circuit Board Market Projected to Reach $69.32 Billion by 2027
    RFID Locks Market to Reach $9.93 Billion by 2027: Allied Market Research

    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