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Implementing an Automated DOE in Twin Screw Wet Granulation
Sustainable Pharmaceutical Packaging
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Parexel Announces CEO Transition
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Plenaries Discuss AI and Next-Gen Modality Development at AAPS NBC
SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
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SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
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The High Five: Key Regulatory Topics for Drug Development in 2024
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The Road Ahead for CDMOs in 2024
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Process Validation
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APIs
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APIs
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Regis Custom Pharma
...
Deanna Rentner, Marketing Coordinator
10.26.23
Analytical Services
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Bioanalytical Services
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Process Development
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Process Validation
Fujifilm Diosynth Biotechnologies Doubles Laboratory Footprint in North Carolina
Expands the sites’ process development, process characterization and analytical services and adds approximately 145 positions by 2024.
01.05.22
Biologics, Proteins, Vaccines
|
Clinical Trials
|
Drug Development
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Inspections
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Process Validation
|
Risk Management
Establishing Commercial Manufacturing Services for Antibody-Drug Conjugates
Learn how to properly structure your development work, perform a thorough process risk assessment and prepare for pre-approval inspection audit.
Sponsored
released by
Merck
06.09.21
Biologics, Proteins, Vaccines
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Breaking News
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cGMP Manufacture
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Industry News
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Process Validation
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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
Bioanalytical Services
|
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
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Microbiology
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Validation
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Bio News
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Lyophilization
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Process Development
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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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Collaborations & Alliances
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Process Validation
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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
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
|
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.
Amber Riley, 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
|
Process Development
|
Process Validation
|
Validation
Sterigenics Expands Germany Location
Increases ethylene oxide processing capacity by 20%
05.10.16
Breaking News
Parexel Announces CEO Transition
DifGen Acquires FDA-Registered Manufacturing Facility
Quotient Sciences Makes Executive Leadership Team Appointments
Plenaries Discuss AI and Next-Gen Modality Development at AAPS NBC
SCHOTT Pharma Invests $371M in U.S. Prefillable Syringe Mfg. Facility
View Breaking News >
CURRENT ISSUE
March 2024
Implementing an Automated DOE in Twin Screw Wet Granulation
Sustainable Pharmaceutical Packaging
Pre-filled Syringe Packaging Trends
Liquid Pharmaceutical Filling: Small, Smaller, Micro Batches
Newsmakers Q&A: BioVectra
Multi-particulate Formulations – Tablets or Capsules?
Manufacturing Equipment Trends
OSD Outsourcing: Savvy CMOs Hone Skills as Complex APIs Fuel Demand
Catalent Acquisition by Novo Holdings: Evolution of the Industry(?)
The Road Ahead for CDMOs in 2024
View More >