Extractables and Leachables
- 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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Drug Delivery | Extractables and Leachables
E&L Considerations for Customized Syringe Delivery Systems
Join James Scull, Ph.D., Scientific Director for Element Life Sciences, to gain a deeper understanding of E&L evaluations of custom drug delivery devices.03.29.21
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Chemistry | Extractables and Leachables | Microbiology
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Extractables and Leachables | Laboratory Testing
The FDA Gets Stricter with E&L Oversight, Can the Industry Keep Up?
Andrew Kolbert of Avomeen discusses FDA oversight of E&L testing, complications that arise, and the expertise needed to keep up with changing quality standardsOnline Exclusives Kristin Brooks, Contract Pharma 07.11.19
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Analytical Services | Extractables and Leachables | Validation
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Capsules | Chemistry | Extractables and Leachables | Fill/Finish | Formulation Development | Supply Chain
Newsmakers: Hanns-Christian Mahler
Head of drug product services talks about Lonza’s new capabilitiesTim Wright, Editor 03.09.16
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Breaking News | Extractables and Leachables | Industry News
Chemic Laboratories and Chemical Solutions Join Forces
Collaboration to focus on a variety of pharma and biopharma client interests02.15.16
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Breaking News | Drug Development | Extractables and Leachables | Formulation Development | Industry News | Parenterals | Process Development
Lonza to Offer Drug Product Development Services
Capabilities will focus on parenteral dosage forms for biologics, drug conjugates, peptides and small molecules02.02.16
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Analytical Services | Chemistry | Extractables and Leachables | Laboratory Testing | Promotions & Moves
iuvo BioScience Appoints Director of Analytical Chemistry
Hires Dr. Christopher Houston, expert in analytical method development and identifying unknown chemical entities11.10.15
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APIs | Breaking News | cGMP Manufacture | Chemistry | Extractables and Leachables | Industry News | Microbiology | Process Development | Process Validation | Validation
SGS Completes New Shanghai Lab
New services include a compound laboratory designed to test products such as antibodies and hormones06.24.15
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APIs | Breaking News | Capsules | cGMP Manufacture | Collaborations & Alliances | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Lyophilization | Process Development
ScinoPharm, Raffles PharmaTech Ink API Alliance
Will manufacture Celecoxib, a non-steroidal and anti-inflammatory analgesic API06.23.15
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Breaking News | Capsules | cGMP Manufacture | Drug Delivery | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Lyophilization | Process Development | R&D | Solid Dosage/Semi-solids | Vials
Juniper Partners with OxSonics on Drug Delivery Platform
Will support development, scale-up, and GMP manufacture of sono-sensitive injectable particles06.23.15
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Bioassay Development | Breaking News | Capsules | cGMP Manufacture | Collaborations & Alliances | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Lyophilization | Methods Development | Process Development | QA/QC | Toxicology | Validation
Goodwin Biotechnology and Aspyrian Therapeutics Form Pact
Collaboration will focus on GMP manufacturing and IND submission for a novel antibody drug conjugate platform06.17.15
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Bioassay Development | Breaking News | Capsules | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Industry News | Inspections | Laboratory Testing | Lyophilization | Methods Development | Process Development | QA/QC | Regulatory Affairs | Toxicology | Validation
ELC Group in Early-stage Development of Novel Influenza Vaccine
One million euro project marks regulatory affairs provider’s entry into pharmaceutical development market06.17.15
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Bioanalytical Services | Bioassay Development | Breaking News | Capsules | cGMP Manufacture | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Industry News | Inspections | Logistics | Lyophilization | Methods Development | Process Development | QA/QC | Serialization | Supply Chain | Toxicology | Validation
SGS Opens New French Laboratory
Upgrades its quality control service offering and broadens capabilities for biologics06.16.15
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Aseptic Processing | Bioassay Development | Breaking News | Capsules | cGMP Manufacture | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Industry News | Inspections | Lyophilization | Methods Development | Process Development | QA/QC | Toxicology | Validation
West Breaks Ground on Waterford, Ireland Manufacturing Facility
Deepens investment in Ireland to support growing global customer demand06.16.15
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Breaking News | Capsules | cGMP Manufacture | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Industry News | Inspections | Lyophilization | Methods Development | Process Development | QA/QC | Validation
Catalent Expands Packaging Capabilities in Singapore
Catalent Singapore facility is awarded GMP certification06.16.15
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Breaking News | Capsules | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Industry News | Inspections | Lyophilization | Methods Development | Process Development | QA/QC | Serialization | Supply Chain | Validation
France-based Serialization Software Specialist Adents Opens First U.S. Office
Princeton, NJ office opens just months after Montreal locale, as company expands its North American footprint06.16.15
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Bioassay Development | Breaking News | Capsules | Clinical Trial Materials | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | GMPs/GCPs | Industry News | Lyophilization | Methods Development | Process Development | QA/QC | Risk Management | Toxicology | Validation
Quintiles Unveils New Predictive and Advanced Analytics Capabilities
Provides identification of potential patient safety issues and actionable insight into clinical trial site performance06.16.15
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Bioanalytical Services | Bioassay Development | Breaking News | Capsules | Chemistry | Drug Development | Extractables and Leachables | Facilities | Fill/Finish | Formulation Development | GMPs/GCPs | Industry News | Inspections | Laboratory Testing | Lyophilization | Methods Development | Process Development | QA/QC | R&D | Solid Dosage/Semi-solids | Toxicology | Validation
New England Biolabs To Build New Cleanroom Facility
Responds to customer needs for reagents use in in vitro diagnostics applications06.12.15
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APIs | Breaking News | Capsules | cGMP Manufacture | Extractables and Leachables | Facilities | Fill/Finish | Formulation Development | GMPs/GCPs | Industry News | Inspections | Lyophilization | Methods Development | Process Development | QA/QC | Solid Dosage/Semi-solids | Validation
