Authors
Latest:
Trends Affecting Biopharmaceutical ManufacturingAlmost half of pharmaceutical industry profits continue to come from biopharmaceuticals.
Latest:
Predicting Viral Clearance at Your BenchtopViral contamination is an inherent risk during the manufacture of therapeutic products such as antibodies, vaccines, viral vectors, and plasma derivates.
Latest:
Advancing Cell & Gene Therapy Expansion processes with the Appliflex ST Single-use BioreactorIn this podcast, we will talk about advancing Cell & Gene Therapy expansion processes. A shift from traditional static and shaken cultivation conditions to a stirred controlled environment is taking place within this industry. Various applications will be discussed where the AppliFlex ST single-use bioreactor have enabled advances in process development.
Latest:
Perceptions and Considerations for Adopting Closed ProcessingThe combination of modular facilities and closed processing offers significant advantages in the production of biopharmaceuticals and is becoming a compelling option for manufacturing.
Latest:
Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
Latest:
Impact of Scalable Freeze/Thaw Cycling on Protein Stability & Structure**Wednesday, October 27, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST** Freezing and thawing at scale of API and BDS biologics is not routine and should be handled with the consideration given to any critical unit operation. This webinar highlights key protein related quality challenges associated with freeze methods. Optimization thorough model freeze/thaw studies are presented.
Latest:
Pharma Services Sector Poised for Continued Growth and ConsolidationThe CRO market will see greater consolidation by both financial buyers looking to consolidate smaller players and larger CRO players wanting to expand into value-added specialty service areas.
Latest:
The Essential Ingredient in any Sponsor-CRO Partnership: TrustTo build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.
Latest:
The Impact of SARS-CoV-2 on Biomanufacturing OperationsThis article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.
Latest:
Streamlining Method Transfer Across Global SitesThis article discusses standardized analytical method-transfer kits that have been developed to streamline method transfer and site certification at Eli Lilly. Use of these kits has been proven to improve overall efficiency and to reduce cost and time requirements for method transfer.
Latest:
On the Brink of Commercialization: How do we bring ground-breaking cell and gene therapies to market faster?Tue, Sep 27, 2022 2:00 PM EDT | 11am PT | 2pm ET | 7pm BST Many novel cell and gene therapies (CGTs) are now entering the commercialization stage but, as developers look to recoup investment and quickly deliver life-saving therapies to the patients that need them, they face a myriad of challenges. In this webinar, learn how advanced therapy medicinal product (ATMP) platforms, using single-use systems, are delivering streamlined, efficient and cost-effective manufacturing solutions in this dynamic sector.
Latest:
Rapid Monitoring of Critical Quality Attributes Using Octet® BLIOctet® BLI systems reduces CQA assay development and run time enabling fast and efficient analysis. Learn how BLI is utilized across a range of CQA applications.
Latest:
Final Thoughts and Looking Forward: The Future of Pandemic PreparednessSustained investment, technological innovation, and collaboration are essential to future pandemic preparedness.
Latest:
Top 10 Cleanroom Problems That Can Be Prevented via Preventative MaintenanceCleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.
Latest:
New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483sThe authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.
Latest:
A Harmonized Approach to Performing a Risk-Based Audit Trail ReviewThe IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
Latest:
Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical TrialsThe authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.
Latest:
Quality, Risk, and Regulatory Drivers Behind Fully Connected Continuous Manufacturing™ (FCCM™)Biomanufacturing has relied on largely unchanged processes for decades, but today’s complex molecules require a smarter approach. Sundar Ramanan, PhD, MBA, Chief Quality Officer at Enzene, explains how fully-connected continuous manufacturing™ (FCCM™) enables this shift by integrating real-time monitoring, automation, and contamination control.
Latest:
Considering a Coating Technology as an Alternative to Silicone OilA coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.
Latest:
Elements for a Sustainable Environmental Monitoring ProgramAsking why things are done a certain way will help make an accurate assessment of an organization’s EM program, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, and Zachary S. Anderson, global market segment lead—Sterility Assurance, Nelson Laboratories.
Latest:
Therapeutic Delivery for Brain-Related ConditionsAt BIO 2024 in San Diego, John Dunlop, PhD, chief scientific officer at Aliada Therapeutics, sat down for an interview with BioPharm International to discuss the firm’s MODEL platform and its potential impact on therapeutic delivery for brain-related conditions.
Latest:
Subjectivity in Quality Risk ManagementThe authors discuss subjectivity in the ICH Q9 (R1) guidance document.
Latest:
Development Strategies for Cell and Gene Therapy MethodsThe increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
Latest:
Development Strategies for Cell and Gene Therapy MethodsThe increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.
Latest:
Connected Software Solutions Streamline Biopharma MS WorkflowsThe integration of modern software tools can make the acquisition and analysis of MS data more efficient, accurate, and compliant.
Latest:
Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical TrialsThe authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.
Latest:
How a Lack of Critical Thinking is Hindering Regulatory ComplianceWhy critical thinking must be applied before technology to ensure regulatory compliance.
Latest:
Strong Quality Culture: A How-To for Busy ManagersBuilding employee participation and forming good habits contribute to a company-wide quality culture that pays off.
