FDA Pharanaceutical Quality Oversight

FDA oversight of drug product quality has in the past been exercised through two key functions: 1) regulatory review of drug applications and 2) inspection of facility compliance with current good manufacturing practices (CGMPs). However, data available to the FDA show that pharmaceutical manufacturing and its regulation, in general, continue to manifest a number of problems:

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Poietis

Poietis develops and produces human, customized tissues using 4D bioprinting for pharmaceutical and cosmetic applications as well as regenerative medicine. Complex 3D tissues are obtained by high resolution Laser-Assisted Bioprinting.

OTHER WHITEPAPERS
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COVID-19 Vaccines Production and Analytical Chemistry Solutions

whitePaper | February 2, 2022

Vaccines work by preparing a person’s immune system to recognize and defend itself against a specific disease.

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Effective solutions for global challenges

whitePaper | April 24, 2023

Despite challenging global conditions, the Swiss biotech industry was able to raise more than CHF 1.33 billion in 2022, with roughly CHF 0.78 billion collected by public companies and the remaining CHF 0.55 billion collected by private companies.

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Establishment of the basidiomycete Fomes fomentarius for the production of composite materials

whitePaper | February 24, 2022

Filamentous fungi of the phylum Basidiomycota are considered as an attractive source for the biotech‑ nological production of composite materials. The ability of many basidiomycetes to accept residual lignocellulosic plant biomass from agriculture and forestry.

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Could DNA be the next big thing in data storage?

whitePaper | August 19, 2021

DNA storage technology is advancing rapidly. Atos is closely monitoring the development of this technology in the hope that future developments will make it a scalable, cost effective and crucially a decarbonized alternative to today’s carbon intensive technologies.

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2022 Global Life Sciences Outlook

whitePaper | January 7, 2022

While valuations for the life sciences sector in this past year have been mixed, the underlying performance and outlook for the sector is healthy

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Bispecific Antibodies Unleashed from Mechanisms to Manufacturing and Strategic Collaboration for Effective Precision Immunotherapy

whitePaper | July 13, 2023

Advances in disease biology have led to the burgeoning development of bispecific antibodies (BsAbs), which are synthetic proteins capable of targeting two discrete epitopes from different antigens. Their bispecific functionality offers promising therapeutic potential such that their applicability to a variety of therapies is being explored.

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Spotlight

Poietis

Poietis develops and produces human, customized tissues using 4D bioprinting for pharmaceutical and cosmetic applications as well as regenerative medicine. Complex 3D tissues are obtained by high resolution Laser-Assisted Bioprinting.

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