• 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

    Aphena Pharma Solutions

    Emergent BioSolutions

    Syngene

    Adare Pharma Solutions
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Cytovance Biologics

    Alcami

    Flow Sciences

    Emergent BioSolutions

    Syngene
    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
    Features

    Rising CMO Business Fortunes

    Several indicators spurring revenue growth for contract manufacturing industry

    Rising CMO Business Fortunes
    Related CONTENT
    • Asymchem
    • Legacy Pharma Solutions
    • Vetio Animal Health
    • Biopharma Manufacturing Markets
    • Tjoapack Invests in Blistering Capabilities
    Adam Runsdorf, President, WDPrx – Woodfield Pharmaceutical, LLC05.08.18
    The relationship of pharmaceutical manufacturers with contract manufacturing organizations (CMO) and contract development and manufacturing organizations (CDMO) is increasingly evolving from one-dimensional product outsourcing into a broad partnership model involving several aspects of development, testing, production and research.

    Several developments occurring from within and outside the pharmaceutical industry are converging to promote a favorable business climate for progressive CMO firms that align their corporate strategies to take advantage of the signs and signals occurring around them.

    Reasons to be cheerful: Two parts
    The growth of the global CMO industry is most clearly observed in the projected increase in revenues, expected to grow from $62 billion in 2016 to $83.9 billion in 2020. 

    Two sets of factors are shaping the promising fortunes of the outsourced manufacturing business: external factors that are occurring outside the direct control of the CMO industry involve financial, economic, structural and regulatory developments; internal factors are driven from within the industry including continuing breakthroughs in large- and small-molecule formulations, an emphasis on services across the value chain, capital investments in technology and persistent cost pressures on manufacturers.

    Consistent quality and reliability are common threads woven through all external and internal factors that manufacturers demand as important measures of project success.

    A little history
    The origins of the CMO industry were brought about by lack of production capacity at manufacturer facilities. The relationship began with contractual agreements to produce active pharmaceutical ingredients (API) or finished dosage forms (FDF). The model operated essentially unchanged until internal and external forces set the stage for growth.

    Dedicated CMO firms as we know them today began operating around 1996 and were dominated by companies in Europe. Prior to this time, pharmaceutical manufacturers maintained loosely defined ‘gentlemen’s agreements’ to produce chemicals and API for each other in order to discourage competition.

    The North American Free Trade Agreement (NAFTA) adopted in 1994 and other similar agreements around the same time opened the floodgates for the CMO industry to derive benefits working with international manufacturers sharing technology across borders.

    The Trans-Pacific Partnership (TPP) trade agreement being negotiated without the United States includes 12 countries representing 40% of the global economy. If we stay on the sidelines, U.S. biopharma companies may be negatively impacted by the agreement concerning intellectual property protections.

    Biopharma manufacturers based in the U.S. are protected from biosimilar competition for 12 years. Any data collected from clinical trials and other R&D initiatives remain the exclusive property of the manufacturer and cannot be utilized by prospective copy-cat organizations.

    The U.S. was the strongest voice in favor of maintaining multi-year protections for data exclusivity. Now that the U.S. is no longer at the negotiating table, the other nations may shorten or eliminate these provisions, increasing competition in the biopharma industry with global repercussions.

    Then came an influx of bio-pharmaceutical companies backed by venture capital funding.  These companies focused on securing a molecule for promising therapeutic value and relied on outsourcing for most business activities, which in turn supported the rise of the contract research organization (CRO).

    These forces built the solid foundation for the fertile business landscape that exists today for the CMO industry.

    Dividing the pie
    Currently the majority of revenue in the CMO sector is derived from API manufacture followed by finished dosage forms and then drug and process development including laboratory work. Business from all categories is expected to rise with API maintaining the prominent revenue position in future. 

    Although the largest slice of the CMO revenue pie is generated by API, the fastest growth vehicle in the international CMO market is finished dosage form manufacturing, forecasted at a 6.9% CAGR through 2026 due mainly to strength of oncology and immunology therapies.

    Closely related to the CMO function are CROs, which provide drug discovery and critical data support as well as contract packaging organizations (CPO) for secondary packaging and labeling. Clearly defined lines of responsibility are now blurring.

    External factors driving CMO business
    The pharmaceutical industry is profoundly affected by external forces that have a direct impact on profitability. All businesses must allow for unforeseen or unexpected circumstances that might disrupt operations. But pharmaceutical manufacturers are in the midst of several developments occurring simultaneously. Leadership of these companies must combine sound financial management with forward-looking strategies in order to prosper.

    Key external challenges for pharmaceutical manufacturers involve more stringent government and regulatory compliance, industry consolidation, continued erosion of traditional corporate structures and economic pressures cutting profit margins.

    The consensus solution among manufacturers to most of these external considerations is their increased reliance on contract manufacturers.

    Regulatory requirements
    Government and other authorities require that manufacturers adhere to stringent standards for regulatory compliance. In some cases, scientific advances in the medical field have occurred faster than the government’s ability to keep current with relevant testing to assure patient safety.

    For example, a new requirement of the United States Pharmacopeial Convention (USP), enforced as of January 2018, sets new analytical and validation requirements for measuring elemental impurities. This new standard replaces a test for heavy metals that was accepted for almost a century.

    Another example of government compliance: the U.S. Food and Drug Administration (FDA) is charged with implementing Federal laws assuring the safety of medications. The most recent FDA Guidance concerning analytical testing requires greater details about drugs and process development than previously published.

    Adding to the administrative obligations, the Drug Supply Chain Security Act (DSCSA) passed into law in by Congress in 2013 imposes many new requirements on manufacturers designed to reduce drug diversion and minimize counterfeit products.

    Manufacturers must make significant investments in internal personnel, external consultants, facilities, equipment and machinery to maintain compliance. The development of more complex molecules and the increasingly sophisticated infrastructure required to successfully process them are prompting corporate leaders to constantly re-examine the costs and benefits of maintaining in-house capabilities to fulfill this purpose. 

    Outsourcing regulatory compliance responsibilities to CMO partners is an increasingly popular solution.

    Industry consolidation and rationalization
    Global investment firms search for industries with a healthy number of profitable players, a diverse supply chain as well as a burgeoning niche of smaller companies exploiting new technologies. The pharmaceutical industry fits this strategy which has historically resulted in industry consolidation, enabling the acquiring company to create internal efficiencies, expand product offerings and incorporate new technologies that would be more expensive to develop from scratch.

    Although 2017 saw fewer mergers compared with preceding years, there were many significant transactions.

    The takeover of Patheon by Thermo Fisher Scientific in May 2017 was valued at $7.2 billion. Johnson & Johnson acquired Actelion, a biopharma company based in Switzerland, for $30 billion and Gilead paid $11.9 billion for the privilege of swallowing Kite Pharma.

    These examples demonstrate the desire for companies to create a ‘one-stop-shop’ for pharmaceutical outsourcing with expertise along the entire supply chain from drug discovery, development, API production, formulation and packaging.

    Industry consolidation is followed by rationalization of resources to streamline administration and increase profitability of the combined venture. For example, a manufacturer with ten CMO relationships taken over by a manufacturer with the same number of CMO vendors may produce an unwieldy total of 20 possible CMO firms under the same corporate umbrella. 

    Decisions are made about how best to reallocate the catalog of outsourced products to the smallest quantity of their best-performing CMO partners. This process results in more business spread out among fewer CMO firms, increasing business volume for the most highly regarded partners.

    Faster approval process
    A faster approval process for drug approvals also contributes to more business for the CMO industry. 

    President Trump made quicker drug approval an issue in the Presidential election. Dr. Scott Gottlieb, Commissioner of the FDA, is capitalizing on recent statements and the passage of the Advancing Breakthrough Therapies for Patients Act of 2012. The Act authorized a new abbreviated approval process for breakthrough therapy drugs to “expedite the development and review of drugs which may demonstrate substantial improvement over available therapy,” according to the FDA.

    According to the FDA Center for Drug Evaluation and Research (CDER), 46 drugs were approved in 2017 compared with 22 in 2016, 45 in 2015 and 41 in 2014, the most since 1996.
    The Commissioner, in written testimony from April 2018 to the House Appropriations subcommittee, further committed to compacting the approval process when he stated is agency will “sharply increase” release of guidance documents designed to assist manufacturers to derive new treatments.

    Summary
    Outside forces are sometimes detrimental to business. Weather-related disasters including the destructive hurricane season of 2017 create significant damage with little warning and with long-lasting effects.

    At other times, outside forces combine to boost business success. Several external circumstances in government and in business are propelling the CMO industry to greater opportunities. Some of the key factors responsible for this business upswing are increasingly stringent regulatory and compliance requirements, financial opportunities creating compelling logic for pharmaceutical industry consolidation and the creation of more efficient drug approval processes resulting in more manufacturing resources being devoted to bringing new products to market.

    Internal factors driving CMO business
    Internal factors positively affecting the CMO industry are issues within the direct control of pharmaceutical manufacturers. These include technological advancements in processes and equipment, additional service offerings and efficiency enhancements. Unlike external forces, internal factors facilitate long-term planning and they are often developed in response to external factors.

    Virtual reality
    Virtual pharma companies reduce fixed costs to a minimum by outsourcing some or most marketing and manufacturing activities to businesses including CMO firms. Typically, virtual pharma companies may employ quality and regulatory professionals and financial and commercial staff. The rise in virtual pharma benefits the CMO industry in several ways.

    First, the investor community has pivoted from focusing on company assets to concentrating on project ownership. The lion’s share of investment funds in virtual operations are available for CMO firms to help the project succeed.

    Second, the rise of the virtual business model shifts more responsibility to the CMO to perform more work compared with a conventional manufacturer. For example, laboratory work including analytical testing and additional services, plus clinical trial management provide expanded opportunities for the CMO to develop deep, long-term relationships with virtual manufacturers.

    Cost pressures create bold CMO initiatives
    The search for profits in a world of shrinking margins is not unique to pharmaceutical manufacturers. However, there are many issues weighing on industry profitability that favor entrepreneurial CMO leaders.

    Pharmaceutical manufacturers face stiff challenges to success including price pressures, raw materials shortages, government oversight, litigation and insurance liabilities. In a nod to the virtual model, the solution for many conventional manufacturers is to reduce operational expenses to achieve greater profit potential.
    Focusing on core capabilities, primarily marketing, research and development, necessitates the downsizing of internal manufacturing capabilities at traditional manufacturers to trusted CMO firms.

    A related development spurring transition to CMO operations is high capital expenditures required for equipment and facilities to meet testing and manufacturing requirements for large molecule APIs, high-potency APIs, biopharmaceuticals and other new molecules. As an example, expensive new high-resolution accurate-mass instruments and other technologies allow for the necessary testing and measurement of biologics. Existing testing equipment may not be able to be upgraded to new standards.

    Conventional manufacturers that have previously spent large sums to upgrade facilities and build new infrastructure based on finite projects or over-enthusiastic sales forecasts are more reticent to make those investments themselves. Entrepreneurial CMO companies offer a solution for risk-averse manufacturers by committing to absorb capital costs up front for new production capacity, strengthening the business relationship with priority manufacturers over a longer contract term. This includes increasing capacity for production of highly potent APIs (HPAPIs) to satisfy increased demand for biologics.

    Ultimately, prudent reliance on reputable CMOs returns additional benefits to traditional manufacturers including a stronger risk management position by producing product at multiple external sites and also reducing potential shortages with advance preparation for manufacturing drugs in short supply at multiple CMO facilities.

    Continuous manufacturing
    Harnessing technology is enabling CMO firms to increase revenues with more cost-effective alternatives to current production methods. To further improve the existing efficiencies for manufacturers, more CMO firms are investing heavily in continuous manufacturing methods in addition to conventional batch processing methods.

    Compared with batch processing, which creates a finished dosage form (FDF) after preliminary phases are performed by multiple parties all converging at the production line, continuous manufacturing involves a single end-to-end production line beginning with the raw materials and ending with a final product or packaged unit ready for sale.

    Batch processing is better suited for smaller runs with multiple products, while continuous manufacturing is designed for production of a specific drug. Compared with batch processing, continuous manufacturing increases speed to market, reduces risk because fewer people from fewer facilities are involved in the manufacturing process and requires a smaller footprint.
    With continuous manufacturing, quality assurance protocols must be adjusted to consistently test and monitor the production line. Progressive CMOs are transitioning to automated testing solutions to meet the requirements of these new production methods.

    Arriving early and staying late
    To spur growth, the CMO industry is taking on capital projects and investing in new technology to share risk with manufacturers. The outcome of these strategies creates a mutual dependence for CMO and client that helps assure long-term and profitable relationships.

    As manufacturers shed non-core business practices, preferred CMO firms take on responsibilities at the earliest stages of the chain that may begin with formulation development and pre-clinical studies, then move on to main business lines of drug development, API production and formulation. As industry consolidation continues, efficiencies may be found in the same CMO becoming involved with end-stage operations that may include packaging responsibilities.

    The results include stronger partnerships and increased involvement between CMO and manufacturer that benefit both parties.

    Conclusion
    Developments within the pharmaceutical industry are creating a favorable environment for CMO growth. The continued popularity of the virtual pharma business model, cost pressures on conventional manufacturers, the ascendency of continuous manufacturing and the efficiencies gained from relying on CMO partners at every stage of the value chain, all point to continued prosperity.

    External factors outside the industry bolster the optimistic outlook. The challenge of adhering to changing and expanding regulatory requirements, disruptive M&A activity from global financial interests and the accelerated pace of drug development and approval all work in favor of broadening ties between manufacturers and the CMO industry.

    One foreseeable challenge to future growth concerns global biopharma companies that are building their own infrastructure to produce their own technologically advanced formulations. New drugs often are produced in very small quantities as specialty pharmaceuticals to treat specific rare conditions. The high profit margins that are realized from these therapies provide justification for these manufacturers to control production internally.

    Another situation with potential effects on future business is the outcome of the Trans-Pacific Partnership (TPP) negotiations, which may jeopardize U.S. interests related to intellectual property rights concerning data collection and results for pharmaceutical development.

    Despite these potential pitfalls, the outlook remains positive for continued rise in business performance for progressive contract manufacturers. 

    References:
    1. Center for Drug Evaluation and Research. “Drug Innovation - Novel Drug Approvals for 2017.” U S Food and Drug Administration Home Page, Center for Drug Evaluation and Research, www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm.
    2. RAPS, Zachary Brennan -. “FDA Chief Scott Gottlieb Promises to Streamline Drug Development Pathway for Biopharma.” Endpoints News, Endpoints News, 18 Apr. 2018, https://endpts.com/fda-chief-scott-gottlieb-promises-to-streamline-drug-development-pathway-for-biopharma/.
    3. Chen, Caroline, and James Paton. “The FDA Is Approving Drugs at a Staggering Pace.” Bloomberg.com, Bloomberg, 6 Oct. 2017, www.bloomberg.com/news/articles/2017-10-06/flurry-of-drug-approvals-has-wall-street-eyeing-pharma-profits.
    4. Healy, Melissa. “FDA’s Program to Speed up Drug Approval Shaved Nearly a Year off the Process.” Los Angeles Times, Los Angeles Times, 5 Dec. 2017, www.latimes.com/science/sciencenow/la-sci-sn-fda-expedited-drugs-20171205-story.html.
    5. Miller, Jim. “Contract Manufacturing Through the Years.” PharmTech Home, 10 Aug. 2017, www.pharmtech.com/contract-manufacturing-through-years?pageID=2.
    6. Wiley-VCH Verlag GmbH & Co. “Chemanager-Online.com.” Deutsch, www.chemanager-online.com/en/topics/pharma-biotech-processing/expanding-role-contract-manufacturing.
    7. EY, The Pharmaceutical CDMO Industry Is Consolidating, www.ey.com/Publication/vwLUAssets/ey-study-opportunities-in-the-consolidating-cdmo-industry/$File/ey-study-opportunities-in-the-consolidating-cdmo-industry.pdf.
    8. “Elemental Impurities Deadline Contributes to Spike in CRLs for Generic Drugmakers.” Regulatory Affairs Professionals Society (RAPS), www.raps.org/regulatory-focus%E2%84%A2/news-articles/2018/1/elemental-impurities-deadline-contributes-to-spike-in-crls-for-generic-drugmakers.
    9. PhD, Adeline Siew. “Advances in Analytical Testing Tools for the Bio/Pharma Industry.” PharmTech Home, 27 Nov. 2017, www.pharmtech.com/advances-analytical-testing-tools-biopharma-industry?pageID=1.

    Adam Runsdorf is President of WDPrx - Woodfield Pharmaceutical, LLC, which specializes in the manufacture and production of non-sterile liquids, gels, semi-solids and suspensions for prescription and OTC products. The on-site laboratory conducts all QA and micro testing and also manages full technology transfer. A complete range of modern equipment supports multiple batch quantities from clinical trial samples to full commercial production. Packaging options include a wide range of plastic and glass bottles and jars, nasal spray devices, metal and laminate tubes.
    Related Searches
    • Clinical Trial
    • Regulatory Affairs
    • pharma companies
    • capacity
    Suggested For You
    Asymchem Asymchem
    Legacy Pharma Solutions Legacy Pharma Solutions
    Vetio Animal Health Vetio Animal Health
    Biopharma Manufacturing Markets Biopharma Manufacturing Markets
    Tjoapack Invests in Blistering Capabilities Tjoapack Invests in Blistering Capabilities
    Recro Pharma Appoints BD Head Recro Pharma Appoints BD Head
    Recro Gainesville Hires Industry Veteran Recro Gainesville Hires Industry Veteran
    President Trump + Biologics = A Win for Drugmakers? President Trump + Biologics = A Win for Drugmakers?
    Janssen Janssen's Supply Chain VP Talks Trends
    Solid Dosage Outsourcing Trends Solid Dosage Outsourcing Trends
    FDA’s Increased Information Transparency FDA’s Increased Information Transparency
    Sterile Fill & Finish Sterile Fill & Finish
    Pharma Year 2017 in Review Pharma Year 2017 in Review
    FDA Accepts Jazz Pharma FDA Accepts Jazz Pharma's NDA for Review
    HHS 2019 Budget Proposal: Key Priorities Impacting Pharma HHS 2019 Budget Proposal: Key Priorities Impacting Pharma

    Related Features

    • Excipients
      Bye-Bye China?

      Bye-Bye China?

      Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.
      Michele Jermini and Enrico Polastro 11.17.20

    • Clinical Trials | Information Technology | R&D
      Decentralized Trials Fuel AI Revolution in Clinical Research

      Decentralized Trials Fuel AI Revolution in Clinical Research

      The life sciences industry is giving clinical a full makeover, dramatically improving how new therapeutics are developed.
      Nick Moss, Vice President of Analytics and Machine Learning, Medable 11.17.20

    • Drug Delivery | Injectables
      Self-Medication: Flexibility for Patients and Drug Manufacturers

      Self-Medication: Flexibility for Patients and Drug Manufacturers

      Bringing together self-medication with auto-injectors and sustainable secondary packaging.
      Matthias Heinrichs, Head of Product Management and Project Engineering, Syntegon Technology 11.17.20


    • The Single-Use Mixing Landscape: Evaluating Your Options

      The Single-Use Mixing Landscape: Evaluating Your Options

      Adoption of single-use technologies has increased markedly in recent years and will continue to grow.
      Mark A. Sitcoske, Founder & CEO, High Purity New England 11.17.20

    • DCAT President Talks COVID-19, Drug Manufacturing and Innovation

      DCAT President Talks COVID-19, Drug Manufacturing and Innovation

      Lonza’s Director of Commercial Development, Sean Diver, was recently named President of DCAT.
      Tim Wright, Editor, Contract Pharma 11.17.20

    • Biologics, Proteins, Vaccines | Biosimilars | Drug Development
      Biopharma Contract Manufacturing: Robust Growth Ahead

      Biopharma Contract Manufacturing: Robust Growth Ahead

      The biopharmaceutical contract manufacturing market is projected to reach $6.3 billion in 2020, and it will continue to grow over the next five years.
      William Downey, HighTech Business Decisions 11.17.20


    • Injectables
      Catering for the Complex

      Catering for the Complex

      The rapidly changing landscape of pharmaceutical packaging.
      Marcelo Cruz, Director Business Development and Marketing, Tjoapack 11.17.20

    • Cold Chain Management | Supply Chain
      Cold Chain Trends

      Cold Chain Trends

      There is a growing need for convenience through Direct-to-Patient and Direct-from-Patient services in clinical trials.
      Vince Paolizzi, Director of NanoCool Sales, Pelican BioThermal 11.17.20

    • Biologics, Proteins, Vaccines | Inspections | Supply Chain
      Inspecting the Unexpected

      Inspecting the Unexpected

      Preparing quality control processes for COVID-19 vaccine candidates.
      Dr. Andrea Sardella and Raffaele Pace, Stevanato Group 11.17.20


    • Scale-up/Technology Transfer
      Ensuring Quality During the Transfer and Scale Up of Rx Drugs

      Ensuring Quality During the Transfer and Scale Up of Rx Drugs

      Defining the key parameters and considerations for a successful technology transfer.
      Tom Chang, President, Bora Pharmaceutical Laboratory Co. Ltd. 11.17.20

    • Scale-up/Technology Transfer
      Modeling Process Safety Workflows in Pharmaceutical Manufacturing Scale-Up

      Modeling Process Safety Workflows in Pharmaceutical Manufacturing Scale-Up

      Identifying, assessing and mitigating threats at every stage of the development pipeline.
      Joe Willmot, Application Leader, H.E.L Group 11.17.20

    • Clinical Trials | Information Technology
      The Role of Electronic Monitoring in Maintaining Medication Adherence

      The Role of Electronic Monitoring in Maintaining Medication Adherence

      Digital solutions offer hope to get patients to take their medications properly.
      Bernard Vrijens, Scientific Lead, AARDEX Group 10.14.20


    • APIs
      Understanding the Importance of Crystallization Processes

      Understanding the Importance of Crystallization Processes

      Crystallization is a crucial aspect of a molecule’s development and can be used to avoid unnecessary cost, risk and development delays.
      Dr. Craig Callahan, Project Scientist, Cambrex Edinburgh 10.14.20

    • Capsules | Solid Dosage/Creams/Ointments
      Capsule Technology Trends

      Capsule Technology Trends

      A look at the capsule market with a particular focus on the factors driving increased demand in non-gelatin-based formulations.
      Julien Lamps, Product Manager, Lonza 10.14.20

    • Aseptic Processing | Fill/Finish
      A Holistic Cleanroom Concept: Higher Quality and Greater Flexibility

      A Holistic Cleanroom Concept: Higher Quality and Greater Flexibility

      Overcoming today’s aseptic fill-and-finish process challenges.
      Ute Schleyer, Project Manager, Site & Plant Development, Vetter 10.14.20

    Trending
    • Fujifilm To Invest $2B In US Manufacturing Site
    • Baxter, Novavax Ink Sterile Manufacturing Agreement
    • A New Era Of Vaccine And Biologic Drug Development
    • Thermo Fisher Buys Novasep's Viral Vector Manufacturing Biz
    • Roche Canada To Invest $500M To Create 500 Jobs In Ontario
    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

    A Surge in Interest for Supplements & Vitamins
    P&G, L'Oréal & Amorepacific Make News at CES
    Three Form Vertical Beauty Alliance
    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