Dear Partners,

Necessitated by the unprecedented situation created by Covid-19, several industry events and tradeshows across the world have been postponed or stand cancelled. While we were looking forward to meet you, we at Piramal Pharma Solutions have had to take several precautionary measures to protect both our employees and customers, worldwide.

As we move forward in these extraordinary times, we want to assure you that that we are operational by taking the right safety measures and abundant precautions to ensure that we continue to support you and your patients.

While all of us are working remotely for now, you can schedule a discussion with us and we would be glad to help ensure you meet your pharmaceutical development and supply needs and thereby, your clinical and commercial timelines.

Please feel free to reach out to us at:

Our best wishes to colleagues, friends and family.

Best Regards,
Piramal Pharma Solutions

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Biotech firms often have tight timelines to prove the concept of their NCE. As a result, modern clinical development pathway requires rapid manufacturing of the “first Kilo”.

The procedures typically available to CMOs for early phase manufacturing are laboratory-based processes, which are designed to manufacture a few grams. The goal at this stage is not to generate a long term economically feasible process, but to deliver high quality material in a safe and efficient manner. Key to this is responsiveness and adaptability in the Process Development laboratory. However, by necessity, little attention has been paid to analytical methods, isolation procedures or process safety upon scale-up.

The recommended approach with these types of projects is to try and initiate as many concurrent activities as possible. Process chemistry, analytical methods, process safety and regulatory requirements  have to be in place when the process is scaled under cGMP.  Typically, first run through of the chemistry is used to generate both data and samples in the following areas.

During the process, a variety of activities need to be executed within a short timeframe and require close and frequent communication between the teams involved (R&D, Analytical and Production). The activities include addition of new analytical methods, tracking impurities and volatiles and designing strategies to control them, as well as identifying and addressing process safety concerns.

The culmination of all these activities are the “typicals” or process representative reactions. These are mock production runs, carried out in R&D laboratories or R&D kilo labs, which are similar to cGMP production, but with analytical involvement.  Data generated from these runs forms the basis of R&D development report, which is in turn used to generate MBR for GMP manufacturing in the plant. Further,  analytical methods are used to generate material specifications which are transferred to the QC team with guidance from the QA team. Finally, the close interaction and support from all teams is the key to ensure successful manufacturing of this ‘first kilo” in a timely manner.


Posted in Newsletters on Jan 02, 2017