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Frontage Expands Capabilities at its Clinical Site in Secaucus, NJ
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What Will Change at FDA for 2021?
RBQM Comes of Age: COVID as a Catalyst for Change
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Metrics Contract Services Completes Russian Regulatory Inspection
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Process Validation
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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
APIs
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Clinical Trial Materials
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Process Validation
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QA/QC
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Regulatory Affairs
Regis Custom Pharma
...
Deanna Rentner, Marketing Coordinator
11.12.20
Bioanalytical Services
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Bioassay Development
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Biologics, Proteins, Vaccines
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Process Development
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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.
Sponsored
released by
Roquette
10.30.20
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
Bio News
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Breaking News
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cGMP Manufacture
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Collaborations & Alliances
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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
Chemistry
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Inspections
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Support Services
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Vials
Contract Pharma Team
...
02.28.19
Bio News
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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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Thermo Fisher, Symphogen Enter Collaboration
To deliver validated, platform workflows for simplified characterization & quality monitoring of complex therapeutic proteins
10.29.18
Logistics
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Process Validation
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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
APIs
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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
Facilities
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Fill/Finish
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Process Development
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Process Validation
Hovione Strengthens Inhalation Services Portfolio
With its new MG2 Tekna Precision Capsule filling unit
01.24.18
Bioanalytical Services
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Collaborations & Alliances
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vTv Therapeutics, Reneo Pharmaceuticals Enter Agreement
The licensing agreement focuses on the PPAR-delta program
12.28.17
Aseptic Processing
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Breaking News
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Facilities
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Industry News
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Process Validation
Sterigenics Expands Capacity
$17.5 million investment in Fort Worth site makes it the largest sterilization facility in the company’s network
08.02.17
Process Validation
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Regulatory Affairs
Process Validation in the Light of Annex 15 and FDA Requirements
...
12.09.16
Analytical Services
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Lyophilization
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Validation
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Vials
Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services is a fully integrated CDMO providing comprehensive process development services, cGMP manufacturing and drug product fill finish services of small molecule and biologic APIs and intermediates.
Stephanie Harrison, Marketing Manager
11.07.16
Capsules
|
Excipients
|
Process Validation
|
Validation
Continuous Granulation Technology Trends
Seeking a smooth path and avoiding dead ends
Dilip M. Parikh, DPharma Group
06.02.16
Process Validation
ILC Dover Demonstrates CrimpLoc System
Next-gen high containment system designed to provide secure closure in pharmaceutical processing
Videos
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|
Laboratory Testing
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Process Development
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Process Validation
|
Validation
Sterigenics Expands Germany Location
Increases ethylene oxide processing capacity by 20%
05.10.16
Drug Delivery
|
Drug Development
|
Excipients
|
Process Development
|
Process Validation
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Risk Management
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Validation
Process Development Trends
An approach to process development of pMDIs using cold fill and pressure fill technology
Steve Haswell, 3M Drug Delivery Systems
05.05.16
Trending
Sterling Pharma Solutions Acquires ADC Biotechnology
Sanofi To Build New $700M Flu Vaccine Facility In Canada
Alkermes, Merck Enter Clinical Trial And Supply Agreement
Ascendia Pharmaceuticals Poised For Expansion
Frontage Expands Capabilities At Its Clinical Site In Secaucus, NJ
Breaking News
Bora Pharmaceuticals Adds Roller Compaction Capabilities
Ascendia Pharmaceuticals Poised for Expansion
Frontage Expands Capabilities at its Clinical Site in Secaucus, NJ
Merck KGaA Selects PRA’s Remote Patient Monitoring Platform
AGC Biologics Appoints Jun Takami GM of Chiba Site
View Breaking News >
CURRENT ISSUE
April 2021
Small Innovators & Niche CROs
Focus on Science
Rapid and Data Rich Chromatographic Method Development
Preparing Your Post Pandemic Talent Strategy
How Modern Near-Infrared Came to Be
Securing Your API Supply Chain: Three Keys to Success
View More >