Effectively Managing Data In Process Development
Addressing data management challenges during drug development calls for a deeper understanding of the shortcomings of today’s methods and the factors you need to consider when adopting a solution to overcome them.
Process Considerations For Closed Connected Processing
Closed connected processing poses new challenges with respect to process development, planning, and execution. This white paper reviews the benefits and challenges with closed processing and connected processing. By giving examples for the implementation of closed, connected processing in large-scale manufacturing, you will be able to explore and assess options that work for your objectives.
Lessons Learned Executing A Closed Connected Processing From Start To Finish
Biomanufacturing is under increased pressure to adapt to market demands, such as reducing costs and bringing life-saving therapies to the people who need it faster. We performed an evaluation of biomanufacturing technologies, which can potentially improve efficiencies, and offer our findings as additional data for consideration when adopting these methods. Read our recommendations from our execution of a closed and connected mAb process from design considerations to scale-up, including the small-scale modeling that directed our process at manufacturing scale.
Getting Your Investigational Drug Regulatory Ready
Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.
Upstream Platform For Continuous Lentiviral Vector Production
Process scalability, lot-to-lot consistency, and the cost and supply of high-quality plasmid are some of the constraints that have made manufacturing of LVs challenging. Here, we demonstrate a high-yield LV production process, using animal-derived component-free (ADCF) media and reagents, where multiple or continuous vector harvests could be obtained from a single batch.
Quantification Of Vector Genomic, Residual DNA In Gene Therapy Vectors
Bringing cell and gene therapy drugs to market requires improvement in many areas, including analytical testing methods, which are used to determine the safety, strength, and purity of viral vectors.
Enabling Fast, Appropriate Drug Product Supply For Phase 1 Clinical Trials
Without the ability to move smoothly from lab concept to manufacture to delivery of GMP clinical supplies to patients, critical milestones could be missed, delaying funding commitments from investors.
Product Development For An Oral Solid Dosage Using Continuous Manufacturing
A thorough evaluation using several small-scale studies should be completed to help determine whether continuous or batch manufacturing is the best fit for your product.
NMR And Mass Spectrometry In Pharmaceutical Development
In this article, the ability of nuclear magnetic resonance (NMR) and mass spectometry (MS) to characterize product composition is demonstrated using detailed examples.
Analyzing Product Formulation Using Raman Spectroscopy
There are several advantages to using Raman spectroscopy for product quality control along with optimizing the percentage of carbamazepine in an amorphous material produced by hot melt extrusion. Compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world all containing the same API itraconazole.