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.
Process Validation
- All
- APIs
- Aseptic Processing
- cGMP Manufacture
- Cleaning Validation
- Clinical Trial Materials
- Cytotoxics and High Potency Manufacturing
- Excipients
- Extractables and Leachables
- Facilities
- Fill/Finish
- Lyophilization
- Parenterals
- Process Development
- Process Validation
- Risk Management
- Scale-up/Technology Transfer
- Solid Dosage/Creams/Ointments
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Biologics, Proteins, Vaccines | Clinical Trials | Drug Development | Inspections | Process Validation | Risk Management
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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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APIs | Clinical Trial Materials | Process Validation | QA/QC | Regulatory Affairs
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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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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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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 validation03.12.19
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Chemistry | Inspections | Microbiology | Process Validation | Regulatory Affairs | Supply Chain | Validation
Support Services
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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
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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 2020Videos
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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 proteins10.29.18
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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 marketOnline Exclusives Betsy Louda, Associate Editor 10.04.18
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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 program06.14.18
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Facilities | Fill/Finish | Process Development | Process Validation
Hovione Strengthens Inhalation Services Portfolio
With its new MG2 Tekna Precision Capsule filling unit01.24.18
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Bioanalytical Services | Collaborations & Alliances | Industry News | Methods Development | Process Validation
vTv Therapeutics, Reneo Pharmaceuticals Enter Agreement
The licensing agreement focuses on the PPAR-delta program12.28.17
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Aseptic Processing | Breaking News | Facilities | 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 network08.02.17
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Process Validation | Regulatory Affairs
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Analytical Services | Drug Delivery | Lyophilization | Process Development | Process Validation | Validation | 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
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Capsules | Excipients | Process Validation | Validation
Continuous Granulation Technology Trends
Seeking a smooth path and avoiding dead endsDilip M. Parikh, DPharma Group 06.02.16
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Process Validation
ILC Dover Demonstrates CrimpLoc System
Next-gen high containment system designed to provide secure closure in pharmaceutical processingVideos
