Organizations recognize the growing need for control of the entire cold chain as the changing global scenario requires highly efficient processes and flexibility.
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality.
Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Some companies, especially those with limited experience in the biopharmaceutical industry, may find themselves unprepared when it comes to beginning the search.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
In today’s changing industry, it is critical we consider several factors about cell culture bioprocessing and the impact they will have on the future of patient treatment.
Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.
Current trends in drug development point toward a growing number of therapies that are targeting smaller patient populations. As the batch sizes required to manufacture clinical and commercial supply of these therapies are smaller than in the days of blockbuster medicines, the equipment and processes for manufacturing have had to change as well, creating challenges for smaller pharmaceutical companies. Rethinking aseptic filling from technology to process to service while meeting shifting market demands will help all participants in the pharmaceutical industry, and ultimately help the smaller patient populations who need targeted therapies.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices — choices that can be conflicting or present differing advantages.
When it comes to clinical supplies, the journey is every bit as important as the destination and the price of failure is high. This paper discusses how supply logistics are changing and contains examples of how Fisher Clinical Services is deploying flexible solutions to ensure secure, efficient and cost-effective passage of clinical supplies.
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