Search Results for 'Process Validation'

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• APIs | Drug Development | Process Validation
  

  Exploring ICP-MS expertise at Almac

  A discussion about Inductively Coupled Plasma Mass Spectrometry (ICP-MS) and its importance within drug development.

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• Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Industry News | Process Validation | Scale-up/Technology Transfer
  

  Avid, Humanigen Enter Lenzilumab Mfg. Agreement

  To expand production capacity for lenzilumab, Humanigen’s therapeutic candidate in development to treat cytokine storm associated with COVID-19.

  Kristin Brooks 02.03.21
  

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• Bioanalytical Services | Bioassay Development | Biologics, Proteins, Vaccines | Process Development | Process Validation
  

  eBook: Increase Time to Market with Precision Dispensing Technology

  Discover how to make safe, productive, efficient bioprocessing a reality by exploring the benefits of precision dispensing technology.

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• Aseptic Processing | Lyophilization
  

  Planning and Executing a Media Fill: A Guide to Aseptic Process Validation for Lyophilized Products

  This webinar from Lubrizol Life Science on Nov 4 will explore key considerations in designing and executing aseptic process simulations for lyophilized products

  09.10.20
  

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  Quality-by-Design Approach to Manufacturing Cell and Gene Therapies

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News
  

  Emergent Signs Manufacturing Agreement with Novavax

  Expanded collaboration now includes NanoFlu and COVID-19 vaccine candidate

  Contract Pharma Staff 04.03.20
  

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• Aseptic Processing | Bio News | Breaking News | Collaborations & Alliances | Industry News
  

  Ritedose, Chargepoint Team Up for Bio Mfg. Project

  CDMO selects ChargePoint’s AseptiSafe bio transfer solution

  04.01.20
  

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  Manufacturing Equipment Technology

  The future of highly compliant, efficient equipment that’s customized to suit a large variety of applications.

  Kristin Brooks, Managing Editor, Contract Pharma 03.04.20
  

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• Solid Dosage/Creams/Ointments
  

  Oral Solids Remain Robust

  Exploring trends in the oral solid dosage manufacturing market with some of today’s leading contract service providers.

  Tim Wright , Editor, Contract Pharma 03.04.20
  

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  Pharma Packaging Roundtable

  Contract Pharma talks trends with contract packagers.

  Tim Wright, Editor, Contract Pharma 03.04.20
  

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• Solid Dosage/Creams/Ointments
  

  Oral Solids Remain Robust

  Exploring trends in the oral solid dosage manufacturing market with some of today’s leading contract service providers.

  Tim Wright, Editor, Contract Pharma 03.02.20
  

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• Breaking News | Industry News | Information Technology | Validation
  

  ValGenesis Digitizes Validation Lifecycle Process

  Across multiple sites for a global CDMO based in southern Europe

  02.13.20
  

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• Breaking News | cGMP Manufacture | Industry News | Information Technology
  

  CDMO Selects ValGenesis VLMS

  To digitize its corporate validation lifecycle process across multiple sites

  02.11.20
  

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• QA/QC
  

  Quality Management: Preserving and Perpetuating Your Record

  CDMOs must ensure that their top priority be delivering the highest quality products.

  Colleen Herczak, Vice President of Quality, Grand River Aseptic Manufacturing 01.28.20
  

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  Managing Partnerships: Sponsors & CDMOs

  How to earn – and keep – your spot atop corporations’ short lists of CDMOs.

  Judy Meyers, Sr. Business Development Manager, Grand River Aseptic Manufacturing 11.20.19
  

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• Analytical Services | Bioanalytical Services | Biologics, Proteins, Vaccines | cGMP Manufacture | Drug Development | Formulation Development
  

  Contract Pharma’s 20th Anniversary Series: Ajinomoto Bio-Pharma

  David Enloe of Ajinomoto Bio-Pharma Services shares his perspective on market changes over the years and the evolution of more integrated outsourcing

  Online Exclusives Kristin Brooks, Contract Pharma 11.11.19
  

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• Breaking News | Facilities | Industry News | Solid Dosage/Creams/Ointments
  

  Metrics Installs High Shear Mixer

  Precision granulator helps manufacturers transition from development to process validation and commercial production.

  10.21.19
  

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  Contract Pharma’s 20th Anniversary Retrospective

  A look back a the pharma/biopharma industry and the future of outsourcing.

  Kristin Brooks, Managing Editor, Contract Pharma 10.15.19
  

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  Biopharmaceuticals & Analytical Testing Technology

  Analytical technology and processes are evolving as the biologics industry continues to grow.

  10.01.19
  

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• Regulatory Affairs
  

  Continuous Manufacturing and its Regulatory Challenge

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  José L. Toro, PhD, Lachman Consultants 09.16.19
  

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• Validation
  

  Pharmaceutical Process Validation: Product Quality, Safety and Efficacy

  Validation must happen at each step of a manufacturing process.

  Robert Glaser, CTO, Auvesy, Inc 09.16.19
  

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• Bio News | Biosimilars | Breaking News | Collaborations & Alliances | Industry News | Scale-up/Technology Transfer
  

  Alvotech, Prestige Biopharma Enter New Manufacturing Partnership

  Alvotech Contract Services to make one of Prestige’s biosimilar candidates

  08.28.19
  

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• Biologics, Proteins, Vaccines | Parenterals
  

  Seasonal Vaccine Manufacturing

  Experience can increase speed and assurance of delivery.

  Wendy Saffell-Clemmer, Lead Scientist, R&D, Senior Director Baxter Pharmaceuticals & Baxter Biopharma Solutions 05.07.19
  

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• Biologics, Proteins, Vaccines | Process Validation
  

  Process Validation in Biologics Development

  Strategies for successful process validation in the wake of faster approval timelines.

  Victor Vinci and Claudia Berdugo-Davis, Catalent Biologics 05.07.19
  

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• Breaking News | Collaborations & Alliances | Drug Development | Industry News
  

  Micro-Sphere Partners With PTM Consulting

  Will offer customers support across the entire drug product development and manufacturing cycle

  05.06.19
  

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• Breaking News | Industry News | Validation
  

  ISPE Releases Good Practice Guide: Process Validation

  Provides insights for fundamental principles, process lifecycle approaches, and changes in validation practices

  03.28.19
  

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• Bio News | Breaking News | cGMP Manufacture | Collaborations & Alliances | Process Validation | Scale-up/Technology Transfer
  

  3P Enters Mfg. Tie-up With Dutch Biotech Xenikos

  3P responsible for process transfer and scale-up, cGMP production for clinical trials and process validation

  03.12.19
  

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• Chemistry | Inspections | Microbiology | Process Validation | Regulatory Affairs | Supply Chain | Validation

  Support Services

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• Regulatory Affairs
  

  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
  

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• Analytical Services | APIs | Capsules | Chemistry | Clinical Trial Materials | Drug Delivery | Drug Development | Drug Discovery | Excipients | Fill/Finish | Formulation Development | Inspections | Microbiology | Parenterals | Process Development | Process Validation | Regulatory Affairs | Risk Management | Supply Chain | Validation | Vials

  Contract Pharma Team

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  02.28.19
  

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• Breaking News | Laboratory Testing | Promotions & Moves
  

  Q Laboratories Appoints Microbiology Supervisor

  Bastin will be responsible for assigning studies to research teams, working with clients and accreditation bodies to draft and optimize study protocols

  01.23.19
  

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• Breaking News | Collaborations & Alliances | Industry News
  

  Alliance Contract Pharma Supports Eye Drug Approval

  FDA green lights first twice-daily, nano-milled ocular corticosteroid

  01.22.19
  

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• Bio News | cGMP Manufacture | Collaborations & Alliances | Facilities | Fill/Finish | Industry News | Lyophilization | Process Development | Process Validation | Serialization | Vials
  

  Grand River Breaks Ground on Major Expansion

  With the support of The Right Place & the MEDC, the 60,000 sq ft facility is expected to be operational by 2020

  Videos

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• Bio News | Bioanalytical Services | Collaborations & Alliances | Industry News | Process Validation | Scale-up/Technology Transfer
  

  Thermo Fisher, Symphogen Enter Collaboration

  To deliver validated, platform workflows for simplified characterization & quality monitoring of complex therapeutic proteins

  10.29.18
  

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• Regulatory Affairs
  

  Reporting CPPs to FDA

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

  Aloka Srinivasan, Ph.D. Lachman, Consultant Services 10.10.18
  

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• Logistics | Process Validation | QA/QC
  

  Nulogy Launches Quality & Compliance Solution

  Capabilities provided to contract packagers are purpose-designed for compliance and GMP compatible and unique to the market

  Online Exclusives Betsy Louda, Associate Editor 10.04.18
  

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• Industry News
  

  WuXi Biologics Executive Receives Service Award

  Dr. Chiang Syin, chief quality officer, received the Foreign Post Service Award for his contributions in the FDA China Office

  09.18.18
  

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• cGMP Manufacture | Solid Dosage/Creams/Ointments
  

  Continuous Pharmaceutical Manufacturing

  Exploring the advantages of continuous over batch manufacture

  Shawn Conway, Ph.D. and Daniel Bowles, Ph.D., Cambrex 09.11.18
  

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• Bio News | Drug Development | Industry News | Trials & Filings
  

  HMP Receives Approval for Elunate

  For the treatment of metastatic colorectal cancer from the National Medical Products Administration of China

  09.06.18
  

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• Drug Development | Industry News | Process Development
  

  Sterigenics Expands European Capacity

  To build new state-of-the-art gamma sterilization facility in the UK

  07.19.18
  

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• APIs | Breaking News | Collaborations & Alliances | Industry News | Process Validation | Regulatory Affairs
  

  WuXi STA Enables Ascletis to Receive NDA Approval from China FDA for Ganovo

  Is first CDMO to support the approval of an innovative drug in China through the MAH pilot program

  06.14.18
  

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• Regulatory Affairs | Solid Dosage/Creams/Ointments
  

  Semi-Solids: A Regulatory Perspective

  Compliance of semi-solid dosages to FDA Stage III Continuous Process Verification.

  José L. Toro, Ph.D., Lachman Consultants 06.12.18
  

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• The Salary Survey & Much More

  From surveys, to drug development & delivery to compliance, the June issue covers a lot of ground

  06.12.18
  

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• Inspections | Regulatory Affairs
  

  PAI Readiness – A Journey, not an Event

  A look at what you need to do to get ready for a pre-approval inspection

  Dr. Walter Matzmorr, Tunnell Consulting 06.12.18
  

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• Bio News | Bioanalytical Services | Collaborations & Alliances | Industry News | Laboratory Testing | R&D
  

  Proteon, Lonza Extend Contract

  For the commercial supply of investigational vonapanitase’s active pharmaceutical ingredient

  05.08.18
  

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• Analytical Services | Breaking News | Industry News | Parenterals
  

  AMRI Highlights Suite of Contract Services

  Visit Booth 1129 at Interphex 2018 to learn more about the complete suite of drug development and manufacturing solutions

  04.17.18
  

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  Pharma/Biopharma Manufacturing And Packaging Equipment Trends

  Regulatory requirements demand quality, diverse drug products demand flexibility, and clients demand ease of use

  Kristin Brooks, Managing Editor, Contract Pharma 03.09.18
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News
  

  Avid Bioservices Forms Mfg. Pact with Enzyvant

  Will manufacture enzyme replacement therapy for Farber disease

  02.21.18
  

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• Facilities | Fill/Finish | Process Development | Process Validation
  

  Hovione Strengthens Inhalation Services Portfolio

  With its new MG2 Tekna Precision Capsule filling unit

  01.24.18
  

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• Promotions & Moves
  

  WuXi Biologics Appoints Chief Quality Officer

  Dr. Syin brings 30 years of experience in FDA regulatory review and GMP compliance of biologics

  01.15.18
  

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