news
FDA clarifies activities during US government shutdown
The FDA has clarified what it can and cannot do in light of the ongoing US government shutdown meaning a lapse in funding during the period...
List view / Grid view
Manufacturing
news
Blood pressure and heart medication recalled by MHRA in UK
The MHRA have announced another sartan-containing drug product over fears that it is contaminated with the carcinogen N‑nitrosodiethylamine...
news
Deloitte finds Pharma returns on R&D reach new low
Deloitte has found a sharp decline in the returns on investment from top pharmaceutical companies, with returns at almost half of what they were in 2010...
news
Correcting minority underrepresentation in MS clinical trials
Minority underrepresentation in clinical trials for drugs to treat MS has led to doctors being unable to make informed decisions when prescribing...
article
Expert View: Beyond API monitoring: in‑line Raman spectroscopy for bioprocess monitoring and control
The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1
article
Expert View: What ADC evolution means for manufacturing
The evolution of antibody-drug conjugates (ADCs) is a spectacular example of how global research can sculpt a new technology. Years of molecular and cell biology, conjugation chemistry and immunology progress has enabled a cytotoxic agent paired with a tumour-specifi c antibody to become mainstream cancer therapy.1 Today, advances continue, explains…
article
Issue 6, 2018
In this issue: Navigating roadblocks to clinical success: decision-making from molecule to clinic, Raman spectroscopy for the qualitative analysis of falsified and substandard medicines, and an overview of risk assessments for elemental impurities: implementation of ICH Q3D guidelines.
news
Ensuring supplier and compounded drug quality
It is paramount that manufacturers and their suppliers ensure that the quality of compounded drugs are high, by preventing risks of contamination...
webinar
Integrated pharma manufacturing – It works
14 December 2018 | By ACG
This webinar focuses on the benefits of integrated pharma manufacturing using examples of integrated processing and packaging solutions. The webinar will also highlight the key advantages of choosing a single pharma solutions provider for all manufacturing needs...
news
Data integrity and compliance with drug current good manufacturing practices
The FDA has provided guidance on data integrity and compliance; two areas extremely important for pharmaceutical businesses and manufacturers to adhere to...
whitepaper
Application Note: Microbiological considerations in cleanroom validation
Contamination, microbiological or otherwise, is a key safety concern in the development and manufacture of all pharmaceuticals and medical devices.
whitepaper
Whitepaper: A high-quality Raman microscope can be recognised by these five criteria
90 years ago Chandrasekhara Venkata Raman and Kariamanickam Srinivasa Krishnan first documented "A New Type of Secondary Radiation," which then became known as the Raman Effect [1, 2]. Raman spectroscopy is based on this effect and is used for qualitative and quantitative analysis of the chemical components and molecules of…
whitepaper
Application Note: Focus on the fundamentals
Fundamentals. The drab cousins of the headline grabbers like AI or Pharma 4.0. But focusing on them can be the investment that offers the most long-term rewards for companies in terms of risk mitigation, cost reduction and improved overall agility. In pharmaceutical packaging and labelling, the key fundamental is the…
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.
