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Smart biomaterial drug delivery system could improve CNS injury recovery
The implanted biomaterial drug delivery system releases methylprednisolone and reduces inflammation, promoting central nervous system (CNS) repair.
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Few CMOs equipped to manufacture cell and gene therapies, finds study
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.
Whitepapers/App Notes/Posters
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.
news
$65 million expansion to HPAPI manufacturing facility
The expansion will be specifically designed to manufacture high-potency active pharmaceutical ingredients (HPAPIs) and complex antibody-drug conjugates (ADCs).
news
Pfizer and BioNTech may supply EU with 200 million doses of COVID-19 vaccine
The companies and European Commission will soon enter contract negotiations for the supply of their investigational COVID-19 vaccine candidate BNT162b2.
news
Biopharma pledges to uphold scientific integrity in COVID-19 vaccine development
Nine biopharma CEOs pledged to make the integrity of the scientific process and sufficient supply priorities in the development of COVID-19 vaccines.
article
Cannabinoid series: growing and extracting APIs
Michael Sassano from Somai Pharmaceuticals and Solaris Farms discusses the US and European markets for growing and extracting cannabinoids for the pharmaceutical industry.
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Canadian government strikes deals with Janssen and Novavax for 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.
Whitepapers/App Notes/Posters
Whitepaper: Characterising insulin as a biopharmaceutical using Analytical Ultracentrifugation
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.
video
On-demand webinar: An update on remote and virtual auditing
NSF expert Dave Waddington discusses the challenges and benefits associated with remote and virtual GMP audits.
article
Overview of workflows and data approaches in bioproduction – an industry perspective
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…
article
Regenerative medicine: a manufacturing overview
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.…
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FDA releases guidance on bioavailability and bioequivalence study samples
The FDA has released guidance on its compliance policy on reserve samples used in bioavailability and bioequivalence studies.
news
Two Phase III trials in US to evaluate efficacy of mAbs against COVID-19
Two randomised Phase III clinical trials to test mAbs against COVID-19 are now enrolling healthy adults in the US, the NIH has announced.
Whitepapers/App Notes/Posters
Data sheet: Viral RNA extraction from saliva and swab samples
RNAdvance Viral Kits. High-quality RNA extraction from saliva or swab transport media. Automation ready. LoD demonstrated at 1 copy/μL.