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.
Risk Management
- 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 | Risk Management
Small-Molecule Drug Development: Advantages of an Integrated, Phase-Based Approach
Small-molecule drug development has become more complex and challenging, leading to greater reliance on CDMOs.Sarah Bethune, Cambrex 09.09.20
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Analytical Services | Breaking News | Risk Management
CluePoints Tech Benefits Clinical Studies Affected by COVID-19
Its COVID-19 risk assessment package and Data Surveillance solution is being utilized in over 200 ongoing studies.Contact Pharma Staff 05.07.20
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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 | Industry News | Regulatory Affairs | Risk Management
Stellar Announces Positive Third-Party Trial Results
The company's KLH manufacturing methods have achieved robust viral clearance05.29.18
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Bio News | cGMP Manufacture | Drug Delivery | Facilities | Industry News | Laboratory Testing | Risk Management
Quay Expands Specialist Isolation Suites
The suites are to support the development of potent drugs in a protective environment03.06.18
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Breaking News | cGMP Manufacture | Drug Delivery | Industry News | Risk Management | Supply Chain
Pharmapack 2018 Announces Winners
The six winners were chosen across two categories: Exhibitor Innovation and Health ProductVideos
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Breaking News | Industry News | QA/QC | Risk Management
Sanofi to Transform its Contracting Foundation
Selects Icertis’ digital platform for cloud management09.01.17
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Drug Development | Risk Management
Mitigating Regulatory Risk for a Global Product Launch
Addressing the critical regulatory challenges life science companies face in today's marketOnline Exclusives Kristin Brooks, Contract Pharma 11.22.16
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APIs | Clinical Trials | Drug Development | Information Technology | Regulatory Affairs | Risk Management
News Highlights from the 2016 Annual DIA Meeting
Comprehend Launches Clinical Intelligence Suite, Quintiles Launches CGM Service Offering, and more...Online Exclusives07.06.16
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Drug Development | Excipients | Lyophilization | Risk Management
Clinical Manufacturing On Time and Within Budget
...David Brett, Vetter Pharma International GmbH 06.02.16
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Biosimilars | Risk Management
India Revises Biosimilars Guidelines
Stricter quality, safety norms on cardsS. Harachand, Contributing Editor 05.05.16
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APIs | Cleaning Validation | Clinical Trials | Drug Development | Drug Discovery | Risk Management | Toxicology | Validation
Setting Health-Based Exposure Limits to Support Pharmaceutical Development and Manufacturing
Health-based exposure limits are needed to support risk assessmentsB.D. Naumann, P.J. Nigro, U. Bruen, L. Parola, D. Cragin and A. Schatz, Merck & Co., Inc. and Ashland, Inc. 05.05.16
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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 technologySteve Haswell, 3M Drug Delivery Systems 05.05.16
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Risk Management | Supply Chain | Validation
Pharma IT Trends
The challenge of implementing MES technology with increased regulationChristian Fortunel, LZ Lifescience 05.05.16
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Risk Management
Should We Call It Risk or Relevance?
What is the difference and what does it mean?Ben Locwin, Contributing Editor 04.05.16
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Breaking News | Industry News | Risk Management
Survey Says Flex Mfg. to Help with Fluctuating Forecasts
Product launch challenges finds forecasts can be off by more than 50%03.16.16
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Inspections | Risk Management | Supply Chain
Quality Metrics: What Does it Really Mean?
Background, thoughts and the current industry dialogue on FDA’s quality metrics initiativeDr. Mike Long, ValSource 03.09.16
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APIs | Drug Development | Formulation Development | Industry News | Logistics | Risk Management | Supply Chain
A Look at DCAT Week ‘16
On the pulse of the pharmaceutical manufacturing value chain, DCAT Week ‘16 will deliver top-flight education programs and networking events.Tim Wright, Editor 01.28.16
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Risk Management
