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Nemera at Interphex 2019
Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generics industries.
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Good Manufacturing Practice (GMP)
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
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Whitepaper: Digital transformation in QA/QC labs
With international regulatory agencies calling for pharma companies to properly manage data integrity issues to ensure GMP compliance, Abbott Informatics demonstrates how their STARLIMS solutions can provide support for numerous systems.
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European Pharmaceutical Review Issue 2 2019
This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
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Flyer: API commercialisation
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long-term API technology development and commercialisation needs.
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Biotechpharma to expand process development and GMP manufacturing capacity to 5,000 L
Biotechpharma UAB will expand its existing manufacturing facility by adding a new line of bioreactors
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FDA identifies hundreds of devices affected by sterilisation facility closures
FDA has launched a notification system where device manufacturers and users may notify the agency of any shortages or related supply issues stemming from sterilisation facility shutdowns...
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Whitepaper: Head-to-head comparison of hydrogen peroxide and steam sterilisation
The pharmaceutical industry is increasingly using different sterilisation technologies rather than steam sterilisation. This increase is driven by the need for sterilising thermo-labile products or areas that cannot be dimensioned as a pressure vessel (barrier systems such as Closed Restricted Access Areas or Isolators), under “softer” conditions.
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Flyer: Biologicals drug substance and drug product
Eurofins CDMO provides a full suite of drug development services encompassing development of the bioprocesses, formulation screening, analytical development, pre-clinical testing, sterile and non-sterile bio-manufacturing of clinical trial batches and orphan drugs.
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Almac Group extends personalised cancer vaccine production facilities
The Almac Group, a CDMO serving the pharmaceutical and biotech sectors globally, is expanding its Edinburgh Technopole facility to allow scale-up of its personalised cancer vaccine activities...
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Application Note: Biologic drug identification at fill and finish
The rapid increase in demand for biopharmaceuticals presents manufacturers with unique challenges to ensure quality and regulatory compliance while maintaining supply and production capacity.
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Five more countries to join EMA-FDA mutual recognition
The US FDA has announced that it will confirm the capability of five more countries to carry out good manufacturing practice (GMP)...
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Whitepaper: Ten things you should know before contracting a custom synthesis project
Companies often need to arrange for the synthesis of test substances to support research and development efforts.
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Whitepaper: The impacts of Brexit on the bio/pharmaceutical industry
On 23 June 2016, the decision was made on the European Union referendum for the United Kingdom to withdraw from the European Union.
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Paul DiMarco introduces BioSpectra as your provider of critical small molecule excipients and APIs
BioSpectra offers US based, custom GMP manufacturing of small molecules...
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Martine tells KLK OLEO’s story in a nutshell
KLK OLEO offers polysorbates, glycerine, MCT oils and more for pharmaceutical applications...
