Search Results for '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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• Drug Delivery | Validation | Vials
  

  Vetter Commercial Manufacturing

  Vetter’s decades of experience as a contract manufacturer providing fill & finish for injectable drugs helps deliver results for both large and small companies.

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• Analytical Services | Drug Delivery | Lyophilization | Process Development | Validation
  

  Vetter Development Service

  With Vetter, you have a partner you can trust to support you throughout drug product development, clinical manufacturing and regulatory approval.

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• Validation
  

  Guide to Maintaining Validation of Older Facilities: Why, When and How

  This guide explains some of the most common challenges found in aging facilities, tips for identifying when a facility requires revalidation and more.

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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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• Breaking News | Industry News | Information Technology | Validation
  

  Global Biosciences Co. Selects ValGenesis VLMS

  Will digitize the validation service activities for efficient and faster access to validated and safer products across 40 countries.

  Contract Pharma Staff 01.20.21
  

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• Breaking News | Industry News | Information Technology | Validation
  

  Gene Therapy Co. Selects ValGenesis' SaaS Platform

  VLMS to digitize Its global validation programs.

  Contract Pharma Staff 01.06.21
  

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• Breaking News | cGMP Manufacture | Industry News | QA/QC | Validation
  

  UK’s VMIC to Implement Lonza’s MODA-EM

  To digitize its Microbiology Quality Control operations.

  Contract Pharma Staff 12.08.20
  

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• 2nd Cleaning Validation Live Event

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  11.09.20
  

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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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• Clinical Trials | CRO News | Drug Development | Information Technology | R&D
  

  CRO Industry Update

  Serge Bodart of IDDI provides insight on the pharma and biopharma trends impacting CROs, outsourcing in today’s market, and advances in clinical research.

  Online Exclusives Kristin Brooks, Contract Pharma 04.27.20
  

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  Pharma Packaging Considerations for Radiation Processing

  Plus, a discussion on the new container closure integrity testing: Mass Extraction. Register now for the May 20th webinar.

  04.22.20
  

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• Vetter’s high performance is again recognized at the 2020 CMO Leadership Awards

  A win in all six core categories reaffirms Vetter as a trusted solution provider

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• Breaking News | Industry News
  

  COVID-19 Update: Serological Test Efforts

  Stephen M. Hahn addresses FDA's approach to expanding access to Serology Tests

  Contract Pharma Staff 04.20.20
  

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

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• Breaking News | Collaborations & Alliances | Industry News
  

  Avacta, Cytiva Collaborate on COVID-19 Rapid Test

  Partnership to develop and manufacture a rapid test for the COVID-19 coronavirus infection for population screening

  Contract Pharma Staff 04.09.20
  

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• Bio News | Breaking News | Facilities | Industry News
  

  Cambrex Completes Biopharma Expansion

  The Durham, NC site now features a range of new instruments, including particle analysis and imaging

  Contract Pharma Staff 04.07.20
  

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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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• Breaking News | Clinical Trials | Industry News
  

  Pharmaseal Offers No Cost Support for COVID-19 Clinical Trials

  Will offer the Engility clinical trials management system at no cost for COVID-19 coronavirus clinical trials

  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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• Breaking News | Promotions & Moves
  

  RSSL Makes Senior Appointment

  Appoints David Ebdon to the newly created role of senior group leader for biological sciences

  04.01.20
  

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• Breaking News | Clinical Trial Materials | Drug Development | Industry News | Scale-up/Technology Transfer
  

  USP Offers Support for COVID-19 Antiviral/Vax Developers

  Aims to help developers ensure quality of their materials as they scale up manufacturing to bring products into clinical development.

  03.19.20
  

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• Bioassay Development | Breaking News | Industry News | Laboratory Testing
  

  COVID-19 Update: FDA Issues EUA to Hologic and LabCorp

  More than 90 test developers have sought FDA guidance for tests they plan to offer through the EUA process

  03.18.20
  

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

  PMI Biopharma Solutions and Nashville Biosciences Form Alliance

  To combine drug discovery support with next-gen sequencing

  03.10.20
  

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• Breaking News | Information Technology | Logistics
  

  ValGenesis Opens New Offices

  New sites in Canada and California continue growth across North America

  03.05.20
  

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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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• Solid Dosage/Creams/Ointments
  

  Flexible Security

  Modern containment solutions guarantee safe and efficient manufacturing processes.

  Fritz-Martin Scholz, Product Manager, Syntegon 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 | Chemistry | Drug Development | Industry News | Information Technology
  

  Pistoia Alliance’s UDM Project Reaches Milestone

  Latest UDM helps build comprehensive data model for chemical reactions to support Lab of The Future and AI adoption

  02.25.20
  

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• Bioassay Development | Breaking News | CRO News | Industry News
  

  Eurofins Grants Bioassay Certification to VelaLabs

  Enables VelaLabs to perform highly reproducible potency lot release assays under GLP/GMP conditions

  02.24.20
  

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• Breaking News | Industry News | QA/QC
  

  ALKU Expands Services to Focus on Analytical R&D

  Expands services into two groups, Pharmaceutical Quality, Validation, and Compliance, and Pharmaceutical Analytical Research and Development

  02.21.20
  

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• Breaking News | Industry News | Promotions & Moves
  

  Sai Strengthens Leadership Team

  Accomplished scientific leader and GSK veteran, Dean Edney joins the CDMO

  02.20.20
  

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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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• Breaking News | Industry News | Information Technology
  

  Legacy Pharmaceuticals Upgrades Operations

  Implements SAP S/4 HANA to move to next generation customer service

  02.10.20
  

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• Essentials in Bioassay Development and Validation

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  02.07.20
  

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Drug Development | Facilities | Industry News
  

  Merck Invests €250M in Biotech Devt. Facility

  15,700 square meter Swiss site designed to bridge research and manufacturing

  02.06.20
  

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• Biologics, Proteins, Vaccines | Clinical Trials | Drug Development | Industry News
  

  Outsourcing in the Cell & Gene Therapy Space

  Specialized and coordinated capabilities aim to accelerate drug development and reduce risk for sponsors

  Online Exclusives Kristin Brooks, Contract Pharma 02.04.20
  

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• Analytical Services | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Clinical Trial Materials | Fill/Finish | Industry News
  

  Catalent to Acquire MaSTherCell

  Adds capabilities and technologies for the development and manufacture of autologous and allogeneic cell therapies, as well as related analytical services

  02.03.20
  

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  Induced Pluripotent Stem Cells in Cell and Gene Therapy – Part 1: Understanding Reprogramming

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• Bio News | Biologics, Proteins, Vaccines | Breaking News | Industry News
  

  3P Bio Completes Vaccine Mfg. Process

  Validation batches of the vaccine against equine strangles Strangvac is completed.

  01.29.20
  

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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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  Realizing the Full Potential of Precision Medicine in Oncology

  Innovation in oncology drug development is being driven by “precision medicine"

  Peter Larson, Executive Medical Director, Hematology-Oncology, Premier Research 01.28.20
  

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  Rising to Market Leadership: TCG Lifesciences

  We talk trends with Swapan Bhattacharya as India’s CRAMS market heats up.

  Tim Wright, Editor, Contract Pharma 01.28.20
  

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• Biologics, Proteins, Vaccines
  

  Biopharma Contract Manufacturing Pricing Analysis

  Expect increased prices over the next two years, but at slightly lower than historical trends

  William Downey, HighTech Business Decisions 01.28.20
  

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• Bio News | Breaking News | Facilities | Regulatory Affairs
  

  PathoQuest Facility Gets GLP Certified

  First company in France to receive GLP Certificate from the ANSM

  01.27.20
  

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• Breaking News | Drug Development | Drug Discovery | Industry News
  

  Evotec, Indivumed Enter NSCLC Research Alliance

  Aims to develop first-in-class therapeutics for the treatment of non-small cell lung cancer

  01.23.20
  

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