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Top Features
Bye-Bye China?
Decentralized Trials Fuel AI Revolution in Clinical Research
Self-Medication: Flexibility for Patients and Drug Manufacturers
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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
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Process Validation
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APIs
Aseptic Processing
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APIs
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Clinical Trial Materials
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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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Process Validation
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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
Chemistry
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Inspections
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Microbiology
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Process Validation
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Regulatory Affairs
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Supply Chain
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Validation
Support Services
...
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Chemistry
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Clinical Trial Materials
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Drug Delivery
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Drug Development
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Drug Discovery
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Excipients
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Fill/Finish
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Formulation Development
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Inspections
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Microbiology
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Parenterals
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Validation
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Vials
Contract Pharma Team
...
02.28.19
Bio News
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Collaborations & Alliances
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Facilities
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Fill/Finish
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Industry News
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Lyophilization
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Process Development
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Serialization
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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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Process Validation
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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
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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Industry News
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Methods Development
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Process Validation
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
|
Facilities
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Industry News
|
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
|
Regulatory Affairs
Process Validation in the Light of Annex 15 and FDA Requirements
...
12.09.16
Analytical Services
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Drug Delivery
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Lyophilization
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Process Development
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Process Validation
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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
Industry News
|
Laboratory Testing
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Process Development
|
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
|
Risk Management
|
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
cGMP Manufacture
|
Logistics
|
Process Validation
|
Validation
CMOs: A Flexibility Alternative
A look at how to include CMOs as an option to improve overall flexibility
Philip K. Burns, CRO-Consulting
01.28.16
Trending
Integrated Continuous Manufacturing ICM
Pfizer, BioNTech Enter Vax Pact With COVAX
CONTINUUS Awarded $69.3M DoD Grant
Piramal Inks Clinical Supply Deal With Theratechnologies
AbbVie Licenses ProBioGen’s GlymaxX Technology
Breaking News
Pfizer, BioNTech Enter Vax Pact with COVAX
FDA Approves Janssen’s CABENUVA
AGC Biologics Appoints Boulder Site GM
Lilly Completes $1B Acquisition of Prevail
Top BioPharma Form Accumulus Synergy
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 >