whitepaper
Case study: Finding impurities and controlling formations at release
Case study example regarding finding impurities and controlling formations at release.
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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 halts COVID-19 vaccine production at Emergent facility
The FDA has requested Emergent’s Bayview plant be closed and vaccine production halted while the agency investigates potential good manufacturing practice (GMP) violations.
article
Your endotoxin experts
ACCI has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for more than 45 years and has grown to be an internationally recognised leader in endotoxin detection. Find out why they should be your choice in of endotoxin experts in this guide.
video
On-demand webinar: Optimising MALDI-TOF for filamentous fungi ID
Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
webinar
Quality Risk Management tools to improve data integrity in micro QC
12 April 2021 | By Charles River Laboratories
Watch this on-demand webinar with Jordi Iglesias to learn how you can improve the data integrity of your microbiological QC assays.
whitepaper
Whitepaper: Continuous wet granulation and fluid-bed drying
Continuous wet granulation and drying have long been a hot topic in pharmaceutical manufacturing. The QbCon® 1 system solves all existing problems.
whitepaper
Brochure: Integrated bioprocessing
The journey from large molecule to approved biotherapeutic is long, costly, complex, and fraught with risk – yet rewards for success are substantial.
video
On-demand webinar: Highway to clinic: Formulation strategies for improved bioavailability
With the appropriate formulation strategies, the challenges around poorly soluble compounds can indeed be overcome. Reducing development time and ultimately speeding up the route to market.
whitepaper
Whitepaper: EU GMP Annex – sterile manufacturing
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
video
On-demand webinar: Testing disinfectant agents for antimicrobial action on hard surfaces
Disinfectants must be qualified on the surfaces in a pharmacopeial manufacturing environment prior to use in the facility. Building a study with robust parameters and avoiding common pitfalls is critical to avoid negative responses from regulatory agencies.
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Keeping momentum in the life sciences sector
In the wake of the UK’s agreed deal with the EU, Andrew Howard, Deputy Director for Trade, Regulation and Analysis in the Office for Life Sciences, offers advice to those life sciences businesses navigating the transition to a new regulatory landscape.
whitepaper
Whitepaper: Early product characterisation mitigates risks in biologics development
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
video
Video series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 2)
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
video
Video series: The champions of iCON: A collaborative discussion on global turnkey solutions (Part 1)
iCON has improved delivery capacity by standardising the infrastructure for a flexible and readily available drug manufacturing facility.
video
On-demand webinar: Key elements of a sterility assurance program
This on-demand webinar will provide aspects of a sterility assurance program for a pharmaceutical product. Sterility assurance begins at the early stages of product development and follows through the entire product lifecycle.
