Lab Services Ramping up
From complex generics to small molecules, no slowdown in sight for labs
In the wake of the COVID-19 pandemic, the significance of laboratory services has been brought to the forefront like never before. These facilities have served as the backbone of public health infrastructure, facilitating diagnostics, monitoring, and research critical for managing and combating the spread of infectious diseases. With funding and innovation programs almost back to pre-pandemic levels, US pharma firms will be looking for the best lab partners to fully leverage their healthy R&D pipelines, as poor laboratory practice yields compliance issues, increased downtime, and delayed product introductions.
As the drug pipeline broadens with the post-pandemic recovery, pharma firms need more early-stage partners to formulate drugs and have their products meet FDA requirements, before thinking about large-scale manufacturing. Beyond diagnosis, laboratory services are crucial for monitoring disease trends and epidemiological patterns. By analyzing data collected through testing and surveillance programs, laboratories provide valuable insights into the prevalence, transmission dynamics, and geographical distribution of diseases. This information is indispensable for public health authorities in devising targeted interventions, allocating resources effectively, and implementing preventive measures to curb disease spread.
Regulators tend to keep pharma executives on their toes. As technologies change, regulations change. Not only is the pharmaceutical industry amongst the most regulated sector, but it is one where regulatory changes are frequent and numerous. Maintaining regulatory compliance is key to patient safety, and this starts in the lab. Trends in FDA-drug approval suggest a recent shift in the way drugs are formulated, particularly when it comes to the development of combination products. For both cost and efficiency purposes, pharma firms have favored reformulating existing drugs rather than restarting the chemistry process completely to create entirely novel ones. Mike Radomsky, CEO of lab contractor CMC Pharmaceuticals, expanded on the development of innovative dosage forms in the API space: “There is growing interest in combination products that incorporate multiple active ingredients into a single formulation.”
“We are seeing a need for modular/flexible facilities that can make small-scale runs of diverse drug products that may be personalized. We are also seeing some overlap with medical devices and drug products, which could prove to be a new frontier, with combined therapies to treat different types of ailments and diseases.”
Arthur Kesisyan, Sector Lead Life Sciences, AtkinsRéalis
The emergence of novel pathogens – caused by endemic factors such as population aging or exogenous ones like climate change – pose a constant challenge to global health security. Laboratory services serve as early warning systems, capable of rapidly detecting and characterizing emerging infectious threats. By leveraging advanced molecular techniques, such as whole-genome sequencing, laboratories can identify new pathogens, track their evolution, and assess their potential for causing widespread harm. India-based ZIM Pharmaceuticals is currently developing “New Innovative Products (NIP)” using its proprietary technology platforms, including molecules that may be crucial to respond the emergence of new pathogens. Anwar Daud, managing director, said: “Topics to monitor will be changing disease profiles and the emergence of ‘cures’ for chronic conditions like diabetes.”
As biotechs secure funding and advance their drug development programs, the demand for lab services is only expected to increase. Laboratories will remain key to providing formulation development, stability studies, and process scale-up services to ensure that the drugs arriving on the market are safe for public health.
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