Authors
Latest:
From Design to Qualification: Creating the Most Efficient Single-Use FacilitiesThrough collaboration and transparency, engineering and automation companies can achieve great efficiencies and success for their customer by integrating intelligent design into a facility.
Latest:
Right the First Time: Bioreactor Scale and Design TranslationThe authors give an overview of scaling approaches and present good scaling practices for the biopharma industry.
Latest:
Media Selection Made Easy: Selecting the Best Media for Your Aseptic Process SimulationMedia fill tests ensure the safe production of parenteral drugs. Learn factors to consider when selecting media for aseptic process simulations including US and European regulatory requirements and eser requirement specifications for equipment and instruments. Tuesday Sept. 29, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST On demand available after final airing until Sept. 29, 2021.
Latest:
Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging ParvovirusesA series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.
Latest:
Helium Leak Detection Technology for Today’s High-Risk PharmaceuticalsThis article will discuss pharmaceutical package testing specifically Helium leak detection technology and how it solves cold supply chain challenges of today’s high-risk pharmaceutical products. This article also addresses the importance of phase appropriate leak testing from manufacturing through product lifecycle.
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:
Comparability in Accelerated or Stressed Stability Studies Using a Quality RangeA statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study.
Latest:
Brazilian Regulation of Biosimilar Products: What Is Important to KnowThis article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.
Latest:
The Optimal Metric of Space-Time YieldSpace-time yield is a critical metric for comparison of upstream biomanufacturing processes and can be useful in reducing commercial production costs.
Latest:
Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
Latest:
Enhancing Process Validation for Sterile Liquid and Freeze-Dried FormsAFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
Latest:
Your Voice in Biopharma's Digital Shift: Manufacturing & Tech Adoption SurveyAt a critical turning point in the adoption of digital tools across the bio/pharma industry, we want to hear to industry professionals on where things actually stand.
Latest:
The Future of Manufacturing, Safety, and CollaborationThe panel highlights the need for continued research, collaboration between stakeholders, and a strategic approach to leveraging mRNA's capabilities to address unmet clinical needs.
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:
Mechanistic Hypothesis of Toxicity: Driving Decision Making in Preclinical TranslationMechanistic toxicity hypothesis is essential in guiding decision-making and predicting toxicities during the preclinical stages of drug development. The authors highlight the growing importance of integrating advanced technologies like mass spectrometry imaging into toxicology to enhance preclinical translation, foster innovation in therapeutic development, and ultimately improve drug safety and efficacy.
Latest:
Getting to the Root of the Matter for Bio/Pharma Quality IssuesBio/pharma can learn ways to prevent recurring events and ineffective CAPA from the nuclear power sector.
Latest:
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical TestingSponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
Latest:
Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug DevelopmentExtrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
Latest:
Michael J. Hennessy: MM&M 40 Under 40 AwardMichael J. Hennessy Jr., president and CEO of MJH Life Sciences™, parent company to BioPharm International, named to MM&M’s second annual 40 Under 40 list.
Latest:
DuPont Innovative Solutions: Addressing the Challenges of Biopharmaceutical ManufacturingWebinar Date/Time: Wednesday, April 2, 2025 11:00 AM EST
Latest:
Solving for Speed in Translational CMCWebinar Dates/Times: May 23rd 2023 8am PST | 11am EST | 5pm CET
Latest:
Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science- and Risk-Based StrategiesMany biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
Latest:
Phase-appropriate Compliance for Cell and Gene TherapiesUnderstanding how to apply phase-appropriate GMPs is crucial for achieving successful regulatory approval.
Latest:
CPHI Annual Survey Finds Global Pharma Resilient with India the Chief Beneficiary of Macro ChangesThese results will provide insights from more than 250 global pharma executives, including discoveries such as pharma confidence dipping below the record scores of 2022, although it has remained extremely resilient despite wider macro uncertainly, according to the press release.
Latest:
Cryogenic Cold Solutions are Enhancing Vaccine Efficacy & YieldsPaper examines how cryogenic cold-temperature solutions are gaining favor versus traditional mechanical refrigeration methods in the manufacturing, storage, and distribution of vaccines due to their enhanced efficacy, stability and yield.
Latest:
Selecting an Off-Site cGMP Storage ProviderThis whitepaper explores the importance of safe cGMP pharma product storage, highlighting challenges CDMOs face with inventory bottlenecks and delays. It examines off-site cGMP storage benefits, including cost savings, flexibility, and compliance, while addressing key factors for maintaining product safety and accessibility.
Latest:
Using Anion Exchange Membrane Adsorbers to Ensure Effective Virus Clearance of Challenging ParvovirusesA series of minute virus of mice spiking studies were performed with a monoclonal antibody product and small-scale AEX membrane adsorbers to evaluate a range of critical processing conditions.
