The implanted biomaterial drug delivery system releases methylprednisolone and reduces inflammation, promoting central nervous system (CNS) repair.
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A report has said that with only 152 CMOs able to manufacture the 7,000 cell and gene therapies in the pipeline, production bottlenecks may occur.
Whitepaper: Considerations in support of achieving successful double blinding and removing bias with over encapsulation
This whitepaper explores critical factors for over-encapsulation success. DBcaps® capsules offer a convenient option for blinding in clinical trials.
The expansion will be specifically designed to manufacture high-potency active pharmaceutical ingredients (HPAPIs) and complex antibody-drug conjugates (ADCs).
The companies and European Commission will soon enter contract negotiations for the supply of their investigational COVID-19 vaccine candidate BNT162b2.
Nine biopharma CEOs pledged to make the integrity of the scientific process and sufficient supply priorities in the development of COVID-19 vaccines.
The Canadian government has agreed that Janssen will supply the country with 38 million doses of its COVID-19 vaccine, while Novavax has agreed to supply 76 million doses if its vaccine.
AUC was used to probe the effect of insulin concentration and the zinc chelating agent EDTA on monomer, dimer, and hexamer formation of USP Human Insulin Standard.
NSF expert Dave Waddington discusses the challenges and benefits associated with remote and virtual GMP audits.
Downstream processing is an integral part of the production process of biopharmaceuticals and contributes quite significantly to the overall productivity and product quality, as well as to processing costs. Melanie Diefenbacher of Genedata provides a comprehensive overview of downstream processes, highlighting several challenges and the importance of investing into automation…
The field of regenerative medicine – an area promising a revolution in 21st century healthcare – has been enabled by rapid scientific advancements in recent years. There is a growing need for a new generation of therapeutic products, made more severe by the global shortages of organs available for transplantations.…
The FDA has released guidance on its compliance policy on reserve samples used in bioavailability and bioequivalence studies.
Two randomised Phase III clinical trials to test mAbs against COVID-19 are now enrolling healthy adults in the US, the NIH has announced.
RNAdvance Viral Kits. High-quality RNA extraction from saliva or swab transport media. Automation ready. LoD demonstrated at 1 copy/μL.