Subscribe to our Newsletters !!
Fermentation is a natural method which is applied
The year 2024 has been momentous for the pharmaceu
The human metapneumovirus, more simply referred to
Indegene, a digital-first life sciences commercial
Alembic Pharmaceuticals Limited (Alembic) announce
'Simplicity' seems to be the perfect word to descr
Dear Readers, Welcome to the latest issue of The Magazine
Any pharmaceutical product that is intended for human consumption must be proven safe, effective, and of high quality, and this can be guaranteed through analytical testing. However, such testing procedures are faced with a myriad of challenges, especially with changing technologies and regulatory requirements.
Analytical testing regimes have also been made problematic with the introduction of biologics, biosimilars, and complex monoclonal antibodies, which express new global complexities.
These nanobodies have complex footprints and often require high-tech characterization. Conventional techniques have failed to cope with the sensitivity and specificity requirements of these advanced molecules.
FDA and EMA and other organizations across the globe have raised the bar when it comes to analytical testing requirements. Apart from these factors, companies have to contend with multiple requirements, safeguard asset verification and show compliance with the guidelines. Making it through these stringent requirements usually means heavy spending on resources and expertise.
The analytical data volume of tested molecules is spiralling and so is the difficulty in assuring accuracy, traceability and integrity. Legacy data systems are hampering several organizations and this puts their compliance at risk.
Pharmaceutical companies are under pressure to fast track development with lower costs. One bottleneck might be analytical testing that is at least multistaged and multitechnique oriented. The dream of speed, cost and quality is quite difficult to achieve.Talent Pool Gap
In the fast-paced environment of Asistria new analytical methods have also created a need for a great deal of skilled personals. But there exists a gap in the quantity of trained manpower who can use tools like mass spectrometers, NMR, and HPLC.
Emerging technologies are revolutionising analytical testing by making more efficient and precise testing options available. For example, the use of UHPLC provides more resolved samples and shorter processing time than older equipment. Moreover, NGS and high-resolution mass spectrometry models will be able to investigate more intricate biological systems.
Constructing advantages into processes with minimal human interaction is reducing repetitive work and human error in analytic labs. Also, AI is augmenting in data analysis with tools that can anticipate and provide insights instantaneously. Such developments not only improve accuracy but also speed up the time taken to make decisions.
Data management challenges faced in laboratories today are being addressed by the modern LIMS (laboratory information management systems) and the modern ELN (electronic laboratory notebooks).
This means data security is achieved, compliance is streamlined, and interoperability is easy, thus boosting operational effectiveness.
A company that views the challenge to always adopt modular testing structures may find it easier to meet changing demands. These types of structures allow the incorporation of the specific analytical methods required for particular purposes, and hence reduce the time and resource costs while still being compliant.
Workforce development is fast becoming the most sought- out investment strategy to reverse the skill gaps. Firms Are setting up training programs and working with universities for their workforce to embrace new technologies and changing legislation.
A big pharmaceutical company is now able to characterize a monoclonal antibody better thanks to the use of advanced mass spectrometry techniques. The use of AI -based software shortened analysis time to a 40% at the very least, allowing for faster movement to clinical studies.
A medium-size biotechnology company has automated its quality control instead using robotic manipulators of samples and analyzing them through AI. This not only enhanced the consistency of the data but cut down 25% of the workforce costs.
It is crystal clear that Industrial Analytical Testing is undergoing changes as appreciated technology evolution is ushering in new possibilities on a whole new scale. But issues must be solved in a more global way, including sophisticated technologies, qualified staff and foresighted investments. Given that the pharmaceutical business now aims at heights previously reached only in fantasy, we would be looking at a future for analytical testing that is collaborative, offers scope for creativity and is flexible. By breaking barriers, the field will push boundaries further in future and will contribute significantly in years to come towards safeguarding the safety and efficacy of life-saving therapies.
