Pharmaceutical Services - Resources and Insights

Our library of digital resources is available to enhance your knowledge-base and educate you along every step of the drug development process. Keep up-to-date with industry hot topics and the latest research developed by our thought-leaders.

ARTICLE	ARTICLE: Repurposing Vaccines for Intranasal Development
E-BOOK	E-BOOK: Flexible Contingency Outsourcing Solutions
WEBINAR	WEBINAR: Quality Control Strategy for Vaccine Development - Rapid Response Strategies
WEBINAR	WEBINAR: Repurposing Products for Inhaled Delivery - Rapid Response Strategies
ARTICLE	ARTICLE: Good Practice for Pharmaceutical Remote Audits
ARTICLE	ARTICLE: Mitigating Risks in Pharmaceutical Batch Release - Enabling contingency sourcing for analytical supplies
WHITE PAPER	WHITE PAPER: Biophysical Characterisation of Tocilizumab

BROCHURE	BROCHURE: Biopharmaceutical Services
BROCHURE	BROCHURE: Pharmaceutical Services
WHITE PAPER	WHITE PAPER: Biophysical Characterisation of Tocilizumab
WHITE PAPER	WHITE PAPER: Monitoring of Glycosylation Analytical Approaches for Antibody-Based Therapeutics
Article	Article: Intranasal Delivery of Biologic Therapeutics and Vaccines
ARTICLE	ARTICLE: Biosimilar Characterisation and Immunogenicity
ARTICLE	ARTICLE: Characterization of Bispecifics
ARTICLE	ARTICLE: Monoclonal Antibody Structural Characterization Challenges
ARTICLE	ARTICLE: New Approaches to Bioassay Design
ARTICLE	ARTICLE: Physicochemical Properties of Liposomal Advanced Drug Delivery Technologies
PUBLICATION	PUBLICATION: Pharma's Almanac Expert Discussion: Technology Developments Impacting Industry
REPORT	REPORT: Current Analytical Approaches to Biophysical Characterisation in a Regulatory Environment
REPORT	REPORT: Designing a Strategic Science-Led Quality Control Program for Peptide Therapeutics
WEBINAR	WEBINAR: Evolution of a Cell-based Assay
WEBINAR	WEBINAR: Monitoring Glycosylation Using Site Specific Approaches
WEBINAR	WEBINAR: Strategic Development of Characterisation and Quality Control Programs for Therapeutic Peptides
WHITE PAPER	WHITE PAPER: GMP Flow Cytometry - Applications, Considerations and Challenges
WHITE PAPER	WHITE PAPER: Strategic Partnerships with Contract Laboratory Organisations
WHITE PAPER	WHITE PAPER: Mitigating Risks in Pharmaceutical Batch Release

WORKSHOP	WEBINAR: Exploring In Vitro-Only Bioequivalence Pathways for Generic Nasal Suspensions
WEBINAR	WEBINAR: The Fundamentals of Inhaled Product Testing
WEBINAR	WEBINAR: Design Verification Testing (DVT) of Metered DPIs
ARTICLE	ARTICLE: Repurposing Vaccines for Intranasal Development
ARTICLE	Article: Intranasal Delivery of Biologic Therapeutics and Vaccines
ARTICLE	ARTICLE: In Vitro Bioequivalence for Pulmonary and Nasal Delivery
ARTICLE	ARTICLE: Nebulised Drug Development Considerations
ARTICLE	ARTICLE: Overcoming Challenges for Inhaled Biologic Development
WEBINAR	WEBINAR: Repurposing Products for Inhaled Delivery - Rapid Response Strategies
WEBINAR	WEBINAR: Advanced Analytical Techniques for Testing Orally Inhaled and Nasal Drug Products
WEBINAR	WEBINAR: Formulation and Manufacturing Approaches for Nasal Drug Products
WEBINAR	WEBINAR: Formulation Strategies for Orally Inhaled and Nasal Drug Products
WEBINAR	WEBINAR: Stability Programs for Orally Inhaled or Nasal Drug Products

ARTICLE	ARTICLE: Physicochemical Properties of Liposomal Advanced Drug Delivery Technologies
ARTICLE	ARTICLE: Assessing Critical Quality Attributes of Viral Vectors
BROCHURE	BROCHURE: Biopharmaceutical Services
BROCHURE	BROCHURE: Pharmaceutical Services
CASE STUDY	CASE STUDY: Addressing Key Attributes of Viral Vectors
CASE STUDY	CASE STUDY: Determining the Proportion of DNA-Packaged and Empty Capsid Populations by Cryo-TEM in Adeno-associated Viruses
PUBLICATION	PUBLICATION: Eliminating Residual Impurities Starts with a Strategic Plan
REPORT	REPORT: Cell Therapy Analytics and Manufacturing 2019
VIDEO	VIDEO: GMP CryoTEM Services: Supporting the development of safe and effective advanced therapies
VIDEO	VIDEO: Cell and Gene Therapy Analytical Development Services
WEBINAR	WEBINAR: Comparison of qPCR and ddPCR methods for Residual DNA Analysis
WEBINAR	WEBINAR: Optimising Protein Impurity Analysis for AAV Capsids
WHITE PAPER	WHITE PAPER: Strategic Partnerships with Contract Laboratory Organisations
WHITE PAPER	WHITE PAPER: Mitigating Risks in Pharmaceutical Batch Release

ARTICLE	ARTICLE: CMC Considerations for mRNA Based Therapeutics
ARTICLE	ARTICLE: mRNA Analytical Development and CMC Support
ARTICLE	ARTICLE: Physicochemical Properties of Liposomal Advanced Drug Delivery Technologies
BROCHURE	BROCHURE: Biopharmaceutical Services
BROCHURE	BROCHURE: Oligonucleotide Development Support Services
BROCHURE	BROCHURE: Pharmaceutical Services
CASE STUDY	CASE STUDY: Determination of Melting Temperature for Oligonucleotide Duplexes using NMR
CASE STUDY	CASE STUDY: GMP Batch Release of Oligonucleotides - Identification Testing by Accurate Mass and MS/MS Sequencing
CASE STUDY	CASE STUDY: Oligonucleotide Identification, Assay and Impurities
PUBLICATION	PUBLICATION: Highlighting Oligonucleotide Characterization Techniques
REPORT	REPORT: Analytical Challenges: Characterisation of Oligonucleotide Therapeutics
WEBINAR	WEBINAR: Development of a QC Strategy for Vaccines (Digital TIDES Week 2020)
WEBINAR	WEBINAR: Comparison of qPCR and ddPCR Methods for Residual DNA Analysis
WEBINAR	WEBINAR: CMC Considerations for mRNA-based therapies
WHITE PAPER	WHITE PAPER: Analytical Strategies for Quality Control of Oligonucleotide Therapeutics
WHITE PAPER	WHITE PAPER: Strategic Partnerships with Contract Laboratory Organisations
WHITE PAPER	WHITE PAPER: Mitigating Risks in Pharmaceutical Batch Release

ARTICLE	ARTICLE: Physicochemical Properties of Liposomal Advanced Drug Delivery Technologies
ARTICLE	ARTICLE: Assessing Critical Quality Attributes of Viral Vectors
BROCHURE	BROCHURE: Cell and Gene Therapy Services
CASE STUDY	CASE STUDY: Addressing Key Attributes of Viral Vectors
CASE STUDY	CASE STUDY: Determining Full Versus Empty Capsids in AAV's with Cryo-TEM
VIDEO	VIDEO: GMP CryoTEM Services: Supporting the Development of Safe and Effective Advanced Therapies
WEBINAR	WEBINAR: Current Analytical Approaches to Advanced Delivery Systems
WEBINAR	WEBINAR: Optimising Protein Impurity Analysis for AAV Capsids
WHITE PAPER	WHITE PAPER: Strategic Partnerships with Contract Laboratory Organisations
WHITE PAPER	WHITE PAPER: Mitigating Risks in Pharmaceutical Batch Release

BROCHURE	BROCHURE: Pharmaceutical Services
FACTSHEET	FACTSHEET: Nitrosamine Analysis in Medicines
ARTICLE	ARTICLE: The Importance of Aligning a Pharma Audit Scope with the Correct Standard
ARTICLE	ARTICLE: A Strategic Approach for Nitrosamine Impurity Screening in Drug Products
ARTICLE	ARTICLE: Physicochemical Properties of Liposomal Advanced Drug Delivery Technologies
WEBINAR	WEBINAR: Analytical Approaches for Identification and Quantification of Impurities In Pharmaceuticals
WEBINAR	WEBINAR: Characterization and Quantification of Known & Unknown Substances by NMR
WEBINAR	WEBINAR: Extractables and Leachables Studies for Process Materials and Container Closure Systems
WEBINAR	WEBINAR: A Hi-Res Accurate Mass Spectrometry Validated Method for Nitrosamine Analysis
WHITE PAPER	WHITE PAPER: Strategic Partnerships with Contract Laboratory Organisations
WHITE PAPER	WHITE PAPER: Mitigating Risks in Pharmaceutical Batch Release
ARTICLE	Article: Identification and Quantification of Potential Epoxide Genotoxic Impurities

ARTICLE	ARTICLE: Biomarker Development & Validation
BROCHURE	BROCHURE: Bioanalysis Services
BROCHURE	BROCHURE: Biopharmaceutical Services
FACTSHEET	FACTSHEET: Trace Metals Bioanalysis and Biomarker Quantification
FACTSHEET	FACTSHEET: Biomarker Development and Validation
WEBINAR	WEBINAR: Innovations in Bioanalytical or Immunogenicity Technologies
WHITE PAPER	WHITE PAPER: Technologies to Measure Immunogenicity
WHITE PAPER	WHITE PAPER: Bioanalytical Quantitative Determination Of Pegylated Species In Human Plasma By NMR
WHITE PAPER	WHITE PAPER: Strategic Partnerships with Contract Laboratory Organisations
WHITE PAPER	WHITE PAPER: Mitigating Risks in Pharmaceutical Batch Release

WEBINAR	WEBINAR: Design of Robust and Sensitive Extractables and Leachables Studies
WEBINAR	WEBINAR: Extractables and Leachables Studies for Process Materials and Container Closure Systems
WEBINAR	WEBINAR: Biocompatibility - The Importance of Extractables & Leachables Testing
WHITE PAPER	WHITE PAPER: Extractables and Leachables Strategies for Pharmaceutical Production Tubing
WHITE PAPER	WHITE PAPER: Extractables and Leachables Strategies for Transdermal Delivery Patch Products
WHITE PAPER	WHITE PAPER: Glass Containers for Pharmaceuticals - Delamination and Interaction Studies
WHITE PAPER	WHITE PAPER: Trace Analytical Methods and Techniques for Testing Extractables and Leachables

INFOGRAPHIC	INFOGRAPHIC: Top 5 Considerations for Outsourcing Stability Storage
ARTICLE	ARTICLE: An Introduction to Inhalation Drug Stability Studies
BROCHURE	BROCHURE: cGMP Stability Study Services
INFOGRAPHIC	INFOGRAPHIC: GMP Stability Storage and Testing
WEBINAR	WEBINAR: Outsourcing Stability Studies to Contract Laboratories; Optimizing Success
WEBINAR	WEBINAR: Stability Programs for Orally Inhaled or Nasal Drug Products
WEBINAR	WEBINAR: Design of Biopharmaceutical Stability Studies
WHITE PAPER	WHITE PAPER: Outsourcing Stability Studies to Contract Laboratories - Keys to Success
WHITE PAPER	WHITE PAPER: Pharmaceutical Stability Contingency Storage and Disaster Recovery

ARTICLE	ARTICLE: Analyzing Leachables from Plastics
WHITE PAPER	WHITE PAPER: Trace Analysis Methods and Techniques for Testing E&L
WHITE PAPER	WHITE PAPER: E&L Testing - An Introduction and Strategies in Current Practice
WHITE PAPER	WHITE PAPER: Elemental Impurities: A Guide to Risk Assessment and Testing
WHITE PAPER	WHITE PAPER: Outsourcing Stability Studies to Contract Laboratories – Keys to Success

LINK	LINK: Healthcare, Pharmaceutical and Cosmetics Auditing Solutions
ARTICLE	ARTICLE: Pharmaceutical Supply Chain Remote Audit Best Practice
INFOGRAPHIC	INFOGRAPHIC: 5 Key Steps to a Successful Healthcare Industry Supplier Audit
ARTICLE	ARTICLE: The Importance of Aligning a Pharmaceutical Audit Scope with the Correct Standard

BROCHURE	BROCHURE: Pharmaceutical and Healthcare
BROCHURE	BROCHURE: Toxicological Risk and Safety Assessments
WEBINAR	WEBINAR: Considerations for Deriving Health-Based Exposure Limits for Active Pharmaceutical Ingredients - Recorded June 21, 2018

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