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.
Compliance
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Drug Development | Scale-up/Technology Transfer | Validation
Keys to Successful Tech Transfer for Topical Pharmaceuticals
This whitepaper illustrates the keys to choosing the right manufacturing partner and how to manage a topical drug tech transfer.
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APIs | QA/QC | Validation
Microbiological Testing Considerations for Pharmaceutical Products
Microbiological testing is a critical component to ensuring the quality and safety of pharmaceutical products. Explore more in this webinar on August 26.07.26.21
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Bioanalytical Services | Biologics, Proteins, Vaccines | Filtration & Purification | QA/QC | Reader Showcase
MOBILion Launches MOBIE HRIM for Biotherapeutic Drug Development
Designed to address characterization challenges during biopharmaceutical drug development and quality monitoring.07.21.21
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Breaking News | Industry News | QA/QC | Regulatory Affairs | Supply Chain
United States Pharmacopeia Acquires Pharmatech Associates
Expanded offerings will help regulated life science companies strengthen the supply chain for safe, quality medicines.07.09.21
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APIs | Breaking News | GMPs/GCPs | Industry News | QA/QC
Purisys Obtains Two Global ISO Certifications
Now certified for ISO 17025 for Testing and Calibration Laboratories and ISO 17034 for Reference Material Producers.07.08.21
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Breaking News | Facilities | Industry News | Validation
Almac’s Charnwood Site Receives ISO Certifications
Achieves globally recognized Health & Safety and Environmental Management System certifications.07.06.21
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Biologics, Proteins, Vaccines | Clinical Trials | Drug Development | Inspections | Process Validation | Risk Management
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Inspections | Validation
From Capital Builds to Staff Augmentation: Tips to Achieving Integrated CQV Strategies
An integrated CQV strategy can support current projects and ongoing operations. This webinar will cover integration strategies in several key areas.06.09.21
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Information Technology | QA/QC | Regulatory Affairs
The Importance of Data Integrity Risk Assessment
Executing Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.Paul Mason, Ph.D., Lachman Consultants 06.07.21
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Breaking News | Facilities | Industry News | Inspections
CPL Completes Successful Virtual Health Canada Audit
The CDMO created a virtual tour of its facilities in response to the pandemic.Tim Wright, Editor, Contract Pharma 06.03.21
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Regulatory Affairs
Meeting with the FDA: Valuing the Statistician and Preparation for Review
A look at the key roles and responsibilities of FDA and biopharmaceutical industry statisticians throughout product lifespan.Joshua Baker, VP and LaRee Tracy, PHASTAR 05.27.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | cGMP Manufacture | Facilities | Industry News | Validation
ADMA Receives FDA Approval for Increased IVIG Production Scale
Increases plant manufacturing capacity from 400,000L to 600,000L.Tim Wright, Editor, Contract Pharma 04.29.21
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Breaking News | Facilities | Industry News | Inspections
Bora Pharmaceuticals Completes Health Canada Inspection
Mississauga site is the company’s first manufacturing facility in North America and is its HQ in the region.Tim Wright, Editor, Contract Pharma 04.23.21
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Clinical Trials | R&D | Regulatory Affairs
Unifying Quality Manufacturing to Drive Speed, Collaboration, and Compliance
Learn how you can unify end-to-end quality management to improve visibility, efficiency, and compliance in this webinar on May 13.04.22.21
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Aseptic Processing | Biologics, Proteins, Vaccines | Capsules | Clinical Trial Materials | Clinical Trials | Fill/Finish | Injectables | Lyophilization | Parenterals | Validation | Vials
Jubilant HollisterStier CMO
Jubilant HollisterStier Contract Manufacturing & Services is an integrated contract manufacturer of sterile injectables, ophthalmics, otics and sterile and non-sterile topicals and liquids.Marcy Edwards, Marketing Manager 04.16.21
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cGMP Manufacture | QA/QC
Ensuring Pharma Manufacturing Quality
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.Online Exclusives Kristin Brooks, Contract Pharma 04.14.21
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Biologics, Proteins, Vaccines | Regulatory Affairs
What Will Change at FDA for 2021?
(R)evolution of the industry’s data, catalyzed by changes at FDA and what’s the likely impact to the pharmaceutical industry?Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 04.01.21
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Clinical Trials | Drug Development | QA/QC
RBQM Comes of Age: COVID as a Catalyst for Change
Clinical trial conduct has undergone a fundamental shift over the last year – and things will never be the same again.Online Exclusives Kristin Brooks, Managing Editor 04.01.21
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Regulatory Affairs
Post-Pandemic Regulations
Envisioning clinical development regulatory practices in a post-pandemic world.Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA 04.01.21
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Analytical Services | APIs | cGMP Manufacture | Excipients | Formulation Development | QA/QC | R&D | Solid Dosage/Semi-solids
Enteris BioPharma: Custom Solutions – From Bench to Market
CDMO operations are housed within a 32,000-square-foot, FDA-inspected and cGMP-compliant facility in northern New Jersey.
