Adopting Smart Development Strategies
External expertise is beneficial in helping companies select the right tools at the right stages of development to ensure success.
Application of F Charts in Continued Process Verification of OSD Forms
This article introduces a control chart technique using F statistic for continued process verification of oral solid dosage forms.
Reformulating Success
There are many benefits of employing a reformulation strategy, but companies must also overcome a variety of challenges too.
Analyzing Extractables and Leachables in Single-Use Systems
Standardized risk assessment and analysis protocols facilitate the comparison of processing equipment components.
Improving Sterility Using Blow-Fill-Seal Technology
BFS technology can help maintain sterility during the biologics manufacturing process.
Electrochemistry for API Synthesis
Numerous benefits will eventually lead to large-scale applications in pharmaceutical manufacturing.
Shining a Light on Lipid Nanoparticle Characterization
Using an orthogonal approach to lipid nanoparticle analysis can increase the odds of project success.
The Future of Drug Delivery for Biopharmaceuticals
Some of the greatest advancements in drug delivery are related to disposable delivery devices, vaccine adjuvants, and wearable pumps, according to Nicholas W. Warne of Pfizer.
The State of Contamination Control
Various advances in contamination control are being utilized to reduce the chance pollutants contaminate a drug product.
Biologic Standards in the Pharmacopoeias: An Update
Awareness of recently implemented—or ongoing—advances by the pharmacopoeias can help biotherapeutic manufacturers remain compliant with current requirements.
Choosing the Right CDMO for CGT Programs
Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.
The Future of Pharmaceutical Environmental Monitoring in Europe
A blended approach to newly revised regulatory guidance to inform environmental monitoring programmes is essential.
Growth in Cell and Gene Therapy Market
Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.
A Royal Tribute
Pharmaceutical Technology Europe pays tribute to the role Her Majesty Queen Elizabeth II had in promoting innovation within life sciences.
Securing Europe’s Critical Entities from Cyber Attacks
Under the revised NIS-2 Directive in Europe, pharma companies will need to be proactive in safeguarding their digital assets.
Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
FDA backs joint reviews, common research policies, and modern production methods around the world.
Industry’s Best Secret
One can only learn the secrets of "fight club" by attending its meetings.
Regulatory Compliance Versus Real Compliance
Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, addresses the difference between regulatory compliance and real compliance.
Ergonomic, Safety-Focused Blenders
ROSS Ribbon Blenders are a customizable solution designed to minimize risk and maximize productivity.
Inorganic DNA Replication Enzyme
The new inorganic pyrophosphate from Canvax is intended for use in RNA IVT reactions.
Continuous Granulator with Integrated Dryer
L.B. Bohle’s QbCon 1 is intended to meet all quality requirements for long granulation processing time.
Next-Generation Synthetic Biology Workflow Platform
Codex DNA’s BioXp 9600 system is designed for the automated synthesis of synthetic biology workflows.
Optimizing Quality
The 1VQ papers advocate for the idea that certain post-approval changes should be streamlined and expedited.