whitepaper
Whitepaper: EPIQ – Solution Brief
EPIQ is a single platform for Quality, Document, and Learning Management. It offers integration across departments for a seamless quality management.
List view / Grid view
QA/QC
news
EMA revises guidance on nitrosamine impurities
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
news
Establishing quality assurance in personalised preparations
A paper has highlighted a drug product quality assurance programme for personalised preparations, including application of a preventive or corrective measures (CAPA) system.
news
Determining accurate estimation of true endotoxin concentration
Research suggests that performing LAL gel clot tests and narrowing the dilution range can provide good estimation of endotoxin concentration in pharmaceuticals.
whitepaper
ebook: Key biomarkers of immunomodulation
Altasciences has published an ebook sharing comprehensive information about testing biomarkers of immunomodulation as part of your drug development program.
news
Autonomous PAT with digital twin integration reported
Autonomous biologics manufacturing with process analytical technology (PAT) “opens up a new frontier for aqueous two-phase extraction (ATPE)" in this sector, according to research.
article
The evolution of AAVs in cell and gene therapy
AAV development for cell and gene therapy in 2023 is being impacted by manufacturing and regulation challenges, however advancing technologies offer opportunity, according to leaders in the field.
news
QMS market to value nearly $4b by 2030
Research predicts the pharma quality management systems (QMS) market will grow significantly in the next several years and is projected to value $3.97 billion by 2030.
news
How can PAT help advance biologics manufacturing?
Lonza’s Associate Director of R&D has offered insight on implementing process analytical technology (PAT) into biologics manufacturing using real-world examples.
webinar
Determining the right regulatory pathway for your drug
12 July 2023 | By Altasciences
Understanding the different regulatory pathways available is critical to getting your drug to market as quickly and safely as possible.
whitepaper
ebook: Accelerate the development of your small molecule
Altasciences’ Proactive Drug Development can accelerate the development of small molecules by up to 40%, from lead identification to clinical POC.
video
Video: The EU Annex 1 Good Manufacturing Process (GMP) updated requirements
How the GMP requirements affect the manufacturing of sterile medicinal products from European Member States and products imported from outside Europe.
news
PDA revises report on glass container manufacturing
Parenteral Drug Association (PDA)'s 2023 technical report on nonconformities in glass containers during pharmaceutical manufacturing represents best practices for identification and classification.
article
Recommendations and considerations for bacteriophage therapy usage in clinical settings
Phage therapy holds great promise as a new therapeutic option in the face of increasing antimicrobial resistance, but sound clinical data remains a stumbling block to its application. Here, Snehit Satish Mhatre from Eurofins Biopharma Product Testing outlines key considerations to address when designing clinical trials.
news
ISO publishes standard on bacterial endotoxin testing
Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.
