• 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
    Spark Therapeutics Appoints CTO

    Cryoport Launches ESG Program

    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail

    Thermo Fisher Scientific Completes Mesa Biotech Acquisition

    Ashfield Engage, Popit Form Digital Monitoring 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

    Solid Dose Market Trends

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    C2 Pharma Completes Multiple Regulatory Filings

    Bormioli Opens New Glass Research Center
    Capsules
    Cold Chain Management
    Injectables
    Logistics
    Serialization
    Solid Dosage / Semi-solids
    Supply Chain
    Vials

    Covectra Introduces Next-Gen Serialization Solution

    Bormioli Opens New Glass Research Center

    Centrient Pharmaceuticals to Acquire Astral SteriTech

    Seasonal Vaccine Manufacturing

    PwC Joins Medicines Manufacturing Innovation Centre
    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

    Ashfield Engage, Popit Form Digital Monitoring Collaboration

    AMRI Contributes to Efforts to Increase COVID-19 Vax Supply

    CatSci Opens New Site in UK

    Pfizer Partners with Medicines Manufacturing Innovation Center

    CrownBio & JSR Life Sciences Partner with Cambridge Quantum Computing
    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

    test company saurabh

    Alcami

    Reed-Lane

    Almac Group
    Companies
    News Releases
    Posters
    Brochures
    Services
    Videos
    Case Study
    White Papers
    Jobs
    Contract Service Directory Companies
    Alcami

    Emergent BioSolutions

    Reed-Lane

    Aphena Pharma Solutions

    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
    FDA Watch

    Reporting CPPs to FDA

    Importance of identifying critical process parameters in original submissions to FDA.

    Reporting CPPs to FDA
    Related CONTENT
    • Improving Product Profitability
    • Syntegon Opens New OSD Customer Center
    • Mogene
    • Understanding the Importance of Crystallization Processes
    • Abzena Invests $60M Into cGMP Manufacturing Capacity
    Aloka Srinivasan, Ph.D. Lachman, Consultant Services10.10.18
    It is well known that quality needs to be built into, rather than tested into, a product. The concept gained renewed interest in the pharmaceutical industry with the publication of FDA’s “Pharmaceutical cGMP for 21st Century-A Risk Based Approach”1 in 2004. This was followed by a number of guidelines, most relevant of which were ICH Q8(R2),2 Q93 and Q10.4

    The term Critical Process Parameter (CPP) became a significant terminology with the publication of ICH Q8(R2), where it was defined as “a process parameter whose variability has an impact on the Critical Quality Attribute (CQA) and therefore should be monitored or controlled to ensure that the process produces the desired quality.” Based on the definition, it is imperative that during the development of the manufacturing process, critical process parameters will be identified and controlled appropriately, to assure the robustness of the process, consistency of the product quality and life cycle management. However, there are many occasions where sponsors fail or incorrectly identify CPPs in their process.

    The definition of CPP in ICH Q8(R2) indicates that a parameter should be considered critical when its variability can affect the CQA of a product. However, neither ICH Q8(R2) nor related publications indicate the amount of impact that would lead one to consider a process parameter as critical. Thus, a strict interpretation of this definition has sometimes led to extremes in the industry. There are some manufacturers who have considered every process parameter that impacts a product attribute as “critical,” irrespective of whether the impact is significant or minimal. This undesirable practice adds unnecessary workload for the manufacturer.

    For the Agency, labeling of all process parameters as critical has the same effect as considering all of them, “non-critical,” as there is no way to evaluate the impact of these parameters on CQAs during commercial manufacturing. Also, this leads to increase in time invested in reporting and reviewing of post approval changes. On the other hand, there are sponsors who have considered none of the process parameters as “critical”; they have argued that when process parameters are controlled appropriately, they assure that the CQAs are met and are thus not “critical.” This does not help either.

    While a sponsor may have done significant work to mitigate risks related to the process parameters, criticality of a process parameter is not a standalone determination and depends on other inputs in the unit operations and also scaling up. Thus, by failing to define a process parameter as critical when it should be so defined, one may lose sight of how changes in this parameter may affect the downstream operations or how an unexpected change in the input material may affect it. The Agency has been making significant attempts to understand the criticality of process parameters in the original submission for several years. FDA Guidance for Industry, “Process Validation: General Principles and Practices”5 recommends reporting a continuum of risk criticality for the parameters. Also, ICH Q93 provides the risk management principles which could be used effectively for understanding the severity of risk related to a process parameter and making a decision whether to consider it “critical.”

    The identification of risk continuum for process parameters can be helpful during evaluation of the manufacturing process. However, providing information regarding mitigation of risk related to a CPP does not always render it non-critical. It is desirable that the knowledge related to criticality of a parameter be retained in the original submission, even when the risk is alleviated. This can also help with cGMP inspections and life cycle management of the product. It assists in allowing the FDA to be cognizant of the kind of changes in the process parameters which could reintroduce the “risk” related to the unit operations.

    While the inputs of a unit operation comprises the critical process parameters (CPPs) and critical material attributes (CMAs) of the incoming materials, the outputs are comprised of the attributes which may translate to CQAs for the product. The critical material attribute or CMA,6 which is not defined by ICH Q8(R2), is comprised of the physical, chemical and biological attributes of an input material which may affect the CQA of a product. The assurance of a consistent output of a unit operation is an interplay of CPPs and CMAs, and variability in either of these could change the output, and thus, CQA of a product. Thus, when a sponsor reports that a “critical” process parameter is non-critical due to process knowledge or development studies, there is risk that it is not re-evaluated if CMAs or other aspects of the process change post approval and lead to product or process failure.

    When CPPs are not identified in the original submission, FDA has asked numerous questions regarding the manufacturing process, impact of variabilities in the CMAs and process parameters, control strategy based on these variabilities, basis of verification of the ranges proposed for the process parameters and the link between the variability of any of the process parameters and CQAs.6
    The two examples of Pharmaceutical Development published by FDA7,8 have mentioned the importance of defining CPPs of a process. Also, as stated in FDA Perspective: Common Deficiencies in ANDAs (Part 4),9 several of the common deficiencies have their root in establishing approprial CPPs in unit operations. The CDER Mapp 5015.10, Chemistry Review of Question-based Review (QbR) Submissions10 has several questions related to evaluation of criticality of process parameters. Also, the importance of CPPs was emphasized in briefing information and presentations for FDA’s Advisory Committee Meeting of September 20, 2018 related to Pharmaceutical Science and Clinical Pharmacology,10 where FDA announced plans for implementation of the Knowledge aided Assessment and Structured Application program (KASA) for review of quality of ANDAs, BLAs and NDAs. This indicates that the Agency is expecting sponsors to provide the information regarding CPPs in their original submissions.

    The defining of appropriate CPPs also has an impact in the life cycle management of a product. With the implementation of ICH Q12,11 FDA is expecting sponsors to provide “established conditions” related to the product and process, for better management of the lifecycle of a product. The FDA Guidance for Industry, “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products”12 provides several elements of the control strategy including process parameters, which may be considered as “established conditions.”

    When ICH Q12 and FDA guidance are fully implemented, FDA is expected to stress the importance of understanding and identifying CPPs for a process and control strategies which mitigate the risk related to these parameters. This way, FDA may be able to determine if the CPP may or may not be an established condition. Sponsors are expected to identify the CPPs in the original submission and discuss the alleviation of the risk related to these parameters. If a CPP is considered an established condition, any changes in the range may have to be reported to the Agency. Alternatively, based on experience and knowledge gained during commercial manufacturing, if a CPP, originally defined as an established condition, is no longer needed to assure the process performance or product quality, a sponsor can remove it with adequate justification through supplements and annual reports. However, for all of the above to be possible, the CPPs need to be identified in the original submission.

    The lack of information related to CPPs in a dossier has led to extensive inquiries from FDA, which have ended in CRLs (complete response letters) and extended the review time of applications. Also, when cited in IR (information request) letters, these questions have time and again led to hasty responses and establishment of ranges based on limited data. These in turn have caused problems with process validation and scale up efforts. Pink Sheet article, “2017 Complete Response Letters: Fewer Than 2016, Still More Than Years Past”13 indicates that though the number of CRLs were less in FY 2017 compared to FY 2016, the number of quality related CRLs in that respective timeframe increased.

    The appropriate risk analysis related to CPPs have affected the Pre-Approval Inspection (PAI) process. To strengthen the FDA inspection process, Dr. Janet Woodcock, Director, CDER, FDA has frequently talked about the Integrated Quality Assessment,14 where the reviewer works with the inspectors to consider all elements that create risk in a product. As part of this initiative, many reviewers are accompanying the inspectors during the PAI. Lack of adequate information in the dossier regarding control strategies and CPPs carry the risk of triggering this kind of joint inspection which could lead to additional observations by the reviewer and inspector, thus delaying the approval process.

    In view of the current trends in FDA, the best practice for a sponsor is to start providing appropriate CPPs in the original submission of the NDAs/ANDAs/BLAs, based on their process understanding. This is expected to mitigate unnecessary risks of delay in approval due to CRLs and/or FDA-483 observations during the PAI inspection. 

    References
    1. U.S. Food and Drug Administration, “Pharmaceutical cGMPs for the 21st Century - A Risk-Based Approach”, September 2004, https://www.fda.gov/downloads/drugs/developmentapprovalprocess/manufacturing/questionsandanswersoncurrentgoodmanufacturingpracticescgmpfordrugs/ucm176374.pdf.
    2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, “ICH Harmonized Tripartite Guideline Pharmaceutical Development Q8(R2), Step 4 Version, August 2009,
    http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf
    3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, “ICH Harmonized Tripartite Guideline, Quality Risk Management Q9”, Step 4 Version, November 2005,
    http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf
    4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use “ICH Harmonized Tripartite Guideline, Pharmaceutical Quality System Q10”, Step 4 Version, June 2008,
    http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf
    5. U.S Food and Drug Administration, “Guidance for Industry, Process Validation: General Principles and Practices”, January 2011,
    https://www.fda.gov/downloads/drugs/guidances/ucm070336.pdf
    6. Maguire, J., et.al., “How to Identify Critical Quality Attributers and Critical Process Parameters”, FDA/PQRI 2nd Conference, North Bethesda, Maryland, October 6, 2015,
     http://pqri.org/wp-content/uploads/2015/10/01-How-to-identify-CQA-CPP-CMA-Final.pdf
    7. U.S Food and Drug Administration, “Quality by Design for ANDAs: An Example for Modified Release Dosage Forms”, December 2011,
    https://www.fda.gov/downloads/Drugs/.../UCM286595.pdf
    8. U.S Food and Drug Administration, “Quality by Design for ANDAs: An Example for Immediate-Release Dosage Forms”, April 2012,
    https://www.fda.gov/downloads/Drugs/.../UCM304305.pdf
    9. Srinivasan, A., et. al., “Common Deficiencies in Abbreviated New Drug Applications (Part 4),”, Pharmaceutical Technology, Vol. 35(4), pp. 62-68,
    http://digital.findpharma.com/nxtbooks/advanstar/pt_201104/index.php?startid=62#/66
    10. U.S Food and Drug Administration, 2018 Meeting Materials, Pharmaceutical Science and Clinical Pharmacology Advisory Committee, September 25, 2018,
    https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinicalPharmacology/ucm617047.htm
    11. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, “ICH Harmonised Guideline, Technical and Regulatory Considerations For Pharmaceutical Product Lifecycle Management Q12”, Draft Version, November 2017, 
    http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q12/Q12_DraftGuideline_Step2_2017_1116.pdf
    12. U.S Food and Drug Administration, “Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry, May 2015,
    https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm448638.pdf
    13. Cipriano, M., “2017 Complete Response Letters: Fewer Than 2016, Still More Than Years Past”, Pink Sheet, January 15, 2018,
    https://pink.pharmaintelligence.informa.com/PS122243/2017-Complete-Response-Letters-Fewer-Than-2016-Still-More-Than-Years-Past
    14. Gottlieb, S., “New Steps to Strengthen FDA’s Inspection and Oversight of Drug Manufacturing,” FDA Voices, August 31, 2017,
    https://www.fda.gov/NewsEvents/Newsroom/FDAVoices/ucm612013.htm



    Aloka Srinivasan, Ph.D.
    Lachman Consultant Services

    Aloka Srinivasan, Ph.D. is Vice President, Regulatory Practice at Lachman Consultants who brings more than two decades of experience in the pharmaceutical industry, including nine years of progressive experience with the U.S. FDA in the Office of Generic Drugs. She provides strategic guidance to applicants in regulatory and chemistry, manufacturing and controls (CMC) for drug products and drug substances at all stages of development and for all types of regulatory submissions.
    Related Searches
    • Dosage
    • ndas
    • it
    • quality
    Suggested For You
    Improving Product Profitability Improving Product Profitability
    Syntegon Opens New OSD Customer Center Syntegon Opens New OSD Customer Center
    Mogene Mogene
    Understanding the Importance of Crystallization Processes Understanding the Importance of Crystallization Processes
    Abzena Invests $60M Into cGMP Manufacturing Capacity Abzena Invests $60M Into cGMP Manufacturing Capacity
    Beyond the Boundaries Beyond the Boundaries
    AAPS Exhibitor List AAPS Exhibitor List
    Reed-Lane Reed-Lane
    Vetio Animal Health Vetio Animal Health
    Contracting And Outsourcing Agenda Contracting And Outsourcing Agenda
    Akorn Receives FDA Warning Letter Akorn Receives FDA Warning Letter
    BIO World Congress on Industrial Biotechnology BIO World Congress on Industrial Biotechnology
    The Great Diaspora of the Pharma Industry The Great Diaspora of the Pharma Industry
    Rho Appoints Southeast SAS President Rho Appoints Southeast SAS President
    DCAT Elects President DCAT Elects President

    Related FDA Watch

    • Solid Dosage/Creams/Ointments
      Recent Advances in Solid Dispersion Technologies

      Recent Advances in Solid Dispersion Technologies

      Improving the bioavailability and therapeutic efficiency of poorly soluble drugs.
      José L. Toro, Directory, Lachman Consultants 01.27.21

    • The Importance of Hypothesis Testing During Investigations

      The Importance of Hypothesis Testing During Investigations

      Why it is critical to have controls in place during out-of-specification investigations to provide quality assurance.
      Paul Mason, PhD, Lachman Consultants 11.17.20

    • Biologics, Proteins, Vaccines | Regulatory Affairs
      Ensuring Manufacturing Continuity for Essential Medicines

      Ensuring Manufacturing Continuity for Essential Medicines

      Applying the principles of Quality Risk Management to get medicines to market faster.
      John Darby, M.Sc., Senior Director, Lachman Consultant Services, Inc. 09.09.20


    • Biologics, Proteins, Vaccines
      Pharma’s Fight Against the Coronavirus Pandemic

      Pharma’s Fight Against the Coronavirus Pandemic

      A look at the pharma industry’s concerted effort to develop vaccines against the SARS-CoV-2 virus and therapeutics to treat COVID-19.
      Keith O. Webber, Lachman Consultant Services, Inc. 07.15.20

    • Information Technology | Regulatory Affairs
      Data Integrity: Beyond Electronic Records

      Data Integrity: Beyond Electronic Records

      Get your Data Integrity house in order
      Tim Rhines, Ph.D., Director, Lachman Consultant Services, Inc. 05.05.20

    • Regulatory Affairs
      Inquiring Minds Want to Know, Just Ask FDA

      Inquiring Minds Want to Know, Just Ask FDA

      What you need to know prior to submission
      Michelle Ryder, Lachman Consultant 04.01.20


    • Regulatory Affairs
      The Art of Filing NDA/ANDA Post-Approval Changes to the FDA

      The Art of Filing NDA/ANDA Post-Approval Changes to the FDA

      Some tips to make your trip along the regulatory pathway to report manufacturing changes easier.
      Amy Schutte, Senior Associate, Lachman Consultant Services 03.04.20

    • Regulatory Affairs
      Inactive Ingredients: Where Guidance Needs to Meet Data

      Inactive Ingredients: Where Guidance Needs to Meet Data

      Looking at FDA’s most recent draft guidance and the struggle with inactive ingredients.
      Sharif Ahmed, Lachman Consultants Services 10.15.19

    • Regulatory Affairs
      Continuous Manufacturing and its Regulatory Challenge

      Continuous Manufacturing and its Regulatory Challenge

      ...
      José L. Toro, PhD, Lachman Consultants 09.16.19


    • QA/QC | Validation
      Considerations for Analytical Method Validation Lifecycle Controls

      Considerations for Analytical Method Validation Lifecycle Controls

      ICH is set to implement new regulatory guidance dedicated to analytical method development
      Paul Mason, PhD, Lachman Consultants 07.15.19

    • Regulatory Affairs
      Effective Post Market Supplier Strategy for Combination Products

      Effective Post Market Supplier Strategy for Combination Products

      Combinations are typically designed, developed and maintained under a robust contract manufacturing process
      Lori-Ann Woodard CBA, CQE, CSQE, Lachman Consultant Services 06.13.19

    • QA/QC
      Nitrosamines

      Nitrosamines

      How to address these unwelcome guests in the pharmaceutical world
      Aloka Srinivasan, Ph.D., Lachman Consultant Services 05.07.19


    • Regulatory Affairs
      KASA to Support Generic Drug Review

      KASA to Support Generic Drug Review

      FDA expects the new system to advance OPQ’s focus on pharmaceutical quality, the foundation for ensuring the safety and efficacy of drugs.
      Sharif Ahmed, Lachman Consultant Services 04.05.19

    • Regulatory Affairs
      FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition an

      FDA’s Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition an

      A look at how the FDA will administer the transition of NDAs to BLAs
      Keith Webber, Ph.D., Lachman Consultant Services 03.06.19

    • Regulatory Affairs
      FDA and Field Alert Reports

      FDA and Field Alert Reports

      Analysis of “Field Alert Report Submission Questions and Answers Guidance for Industry”
      Constance Richard-Math, Lachman Consultants 09.11.18

    Trending
    • Pfizer Selects Seven Bridges To Support RNA Sequencing Data
    • Pfizer Partners With Medicines Manufacturing Innovation Center
    • Catalent Acquires Delphi Genetics
    • Charles River Acquires CDMO Cognate BioServices
    • Spark Therapeutics Appoints CTO
    Breaking News
    • Spark Therapeutics Appoints CTO
    • Cryoport Launches ESG Program
    • U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    • Thermo Fisher Scientific Completes Mesa Biotech Acquisition
    • Ashfield Engage, Popit Form Digital Monitoring 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

    Preliminary Study Links Markers of Impaired Bone Health to Vegan Diet
    Refined Grains Linked to Heart Attack Risk, Early Death
    Kappa Bioscience Extends Research Partnership For COVID-19 Research
    Coatings World

    Latest Breaking News From Coatings World

    Nippon Paint Marine Wins Korea Export Award
    Universal Display Corporation, PPG Expand Global Production of UniversalPHOLED Materials
    PPG Introduces Premium Iso-free Primer Surfacer, Catalyst
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    January AI Raises $8.8 Million in New Funding
    FDA Clears Ava Fertility Tracking Wearable Device
    First Patient in Europe Treated With Diamondback 360 Coronary Orbital Atherectomy System
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Spark Therapeutics Appoints CTO
    Cryoport Launches ESG Program
    U.S. Govt. Purchases 100k Doses of Lilly's COVID-19 Antibody Cocktail
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    The Top Beauty Products of 2021, According to HelloGiggles
    Estée Lauder Taps Ana de Armas as Global Brand Ambassador
    Sephora Announces Significant Expansion
    Happi

    Latest Breaking News From Happi

    ACI Urges Senate to Approve Regan as EPA Administrator
    Estée Lauder Signs Actress Ana de Armas
    GUM Recalls Oral Spray
    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
    Marshall & Bruce Adds Koenig & Bauer Rapida 106 41-Inch Seven-Color Press
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    FTA converts Forum & INFOFLEX to virtual events
    Xeikon launches two new digital label printing presses
    UFlex adds capacity in packaging films
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Texas Medical Technology Partners with My Protect Kit
    Mexico City Single-Use Plastics Ban Leads to Tampon Shortage
    Believe Diapers Launch in U.S.
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    Fusion Robotics Receives FDA Clearance for Spinal Navigation and Robotics System
    Kaia Health Unveils Next-Gen Complete MSK Care Solutions
    First Implantation of CTL Amedica's Minimally Invasive Flex Tower
    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
    Global Smart Glass Market to Register 6.8% CAGR Between 2021-28: Grand View 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