news
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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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.
news
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...
whitepaper
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.
whitepaper
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.
news
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...
whitepaper
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.
news
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)...
whitepaper
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.
whitepaper
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.
product
Paul DiMarco introduces BioSpectra as your provider of critical small molecule excipients and APIs
BioSpectra offers US based, custom GMP manufacturing of small molecules...
product
Martine tells KLK OLEO’s story in a nutshell
KLK OLEO offers polysorbates, glycerine, MCT oils and more for pharmaceutical applications...
article
Wickham Laboratories: Drawing on deep technical expertise
Wickham Laboratories draws on deep technical expertise, backed by decades of global experience, when identifying challenges and providing solutions for a broad range of products and testing scenarios.
article
Eurofins: The largest scope of global services. The sharpest focus on data integrity.
Eurofins BioPharma Product Testing’s facilities deliver the world’s most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.
article
Charles River: Accugenix® microbial identification and strain typing services
Accugenix ® microbial identification and strain typing services, from Charles River, offer unparalleled accuracy in identifying microbes.
webinar
Take control of your impurities testing
5 October 2018 | By PerkinElmer
The control of impurities plays a crucial role in Pharma QA/QC and can be divided in 3 main buckets: Organic, Inorganic and Residual Solvents. On this webinar we are focusing on analytical techniques used for control of Inorganic impurities and Residual Solvents...
