There are many updates to this area that will further improve efficiency, simplification of processes, accuracy and quality in the industry.
Since the beginning of the COVID-19 pandemic, providers offering contract testing services have seen various changes and improvements to everyday processes. According to Pradeep Phalke, Associate Vice President and Head of Analytical Development at Syngene International Ltd, there are many updates to this area that will further improve efficiency, simplification of processes, accuracy and quality in the industry.
New analytical processes
PharmTech: Are there any new processes involving bioprocessing/testing services that are occurring at the labs?
Pradeep Phalke: Increased digitalization of the processes that otherwise run manually has been one of significant changes during and post COVID-19 pandemic. Simplification and efficiency gain is the outcome, which has helped the CROs/testing service labs in-turn delivering the projects as per client requirements. Another change is the increased familiarity and use of online communication tools. This has helped in reducing the gaps that otherwise may come when working in absence of face-to-face meetings or personal connect. Syngene has successfully implemented tools to digitalize the QMS [quality management software] system, in-turn improving turnaround times as well as regulatory compliance. Efforts are also being put to bring in digitalization in development labs, example use of e-lab notebooks and softwares supporting QbD (quality by design) concept.
Shifts in testing services–analytical testing
PharmTech: Are analytical testing services still benefitting bio/pharma companies in terms of cost savings or efficient development times? If not, what are companies moving towards?
Phalke: Analytical testing services are definitely delivering benefits to bio/pharma companies. [A] successful example of this can be dosage development for FIH (First In Human) clinical trials that [can be delivered] to various small as well as large bio/pharma companies. [Flexible solutions], for example, as a “one stop shop” or modular solution provider/development partner, has helped the smaller and large bio/pharma companies alike. For smaller companies, the advantage is in terms of gaining cost advantage by utilizing established facilities … , whereas for larger pharma companies, the benefit has been in terms of gaining time to deliver discovery projects to clinical trials.
Shifts in testing services–CDMOs/CMOs
PharmTech: How are contract development and manufacturing organizations/contract manufacturing company (CDMOs/CMOs) looking to change testing services soon?
Phalke: Faster turnaround time with accuracy and quality is the requirement when it comes to industry expectations from CDMOs/CMOs. Along with this, regulatory requirements are evolving as the scientific understanding deepens. For example, the requirement to assess risks associated to nitrosamine impurities can be the same as testing the drug products, if required. Understanding the project requirements as well as building up agile systems and processes is the key to successful collaboration between pharmaceutical companies and CDMO/CMO partnership. Apt use of the regulatory approaches, such as phase appropriate quality systems, scientific risk assessment and communication thereof, are key factors for any project at CDMO/CMO.Building up capabilities which cater to the challenges faced by our customers is an approach that Syngene has adopted. An example of this is establishing dedicated testing center for Nitrosamine impurities in newly developed and legacy products.
Looking ahead–stability testing programs
PharmTech: Stability testing programs have been discussed in the past for small-molecule drugs and biologics. Do you see this continuing for the bio/pharmaceutical industry, or is there something else being used instead?
Phalke: Stability evaluation is a mandatory requirement for any pharmaceutical dosage form that is sold on the market or compounds going into any clinical study. This requirement is based on scientific principles, like the Arrhenius equation. It is also an integral part of the pharmaceutical regulatory framework, like ICH [International Council for Harmonisation] Q1 A to Q1 F. The stability evaluation helps predict the shelf life of any product. In the absence of assigned shelf life, the patient may not be sure till what period any medication can be stored or is safe to consume. Along with this, the storage conditions in which any given medication is to be stored. These form an integral part of patient safety evaluation while developing any pharmaceutical dosage form, be it small molecule or large molecule. At the advent of some new tools, such as ASAP prime software, the stability evaluation periods can be reduced with thorough scientific understanding. However, tools like these require detailed and widespread scientific evaluation to gain regulatory acceptance.