4 The Pii Formula, Tech Transfer, December 23

4 The Pii Formula, Tech Transfer, December 23

Pii Formula

As 2023 comes to a close, The Formula takes a look back at the most beguiling aspects of drug development: scale up and tech transfer. According to Blue Hatch Consulting, a failed tech transfer will at best result in delays to product sales and increased costs, and at worst may lead to 483 notices, warning letters, loss of reputation, and most importantly an impact on the health of potential recipients of the treatment. Find out here how to manage a scale up when you have limited and expensive API. Learn what to look for in your CDMO partner as you embark on a tech transfer. And, see how Pii’s tech transfer plans ensured two drugs met their milestone product launch. The Formula wishes you a safe and happy holiday season, and we look forward to receiving your questions and feedback in the new year at urana@pharm-int.com.

Main Feature: Managing the Challenges of Small Batch Formulations

It is critical that a drug’s formulation and process are well understood for manufacture at the required scale. A risk-based investment in understanding small scales can prevent costly issues later during scaling development. Read here to learn how to identify the best CDMO to help de-risk dosage form scale up.

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CDMO Insights: 10 Qualities Your CDMO Should Have for a Successful Oral Dose Tech Transfer

CDMOs offer to support pharmaceutical companies in their OSD development. As you seek a CDMO partner, consider these 10 attributes that can ensure a successful, faster, and cost-effective OSD tech transfer.

Project Feature: Successful Tech Transfer Plans Ensured On-Time Launches for Two Sponsors

Pii’s formulation and MSAT teams worked with drug sponsor clients to achieve successful and on-time tech transfers by identifying processing and production failures. Read More

Q and A

Q&A: Do you have a question for the Pii scale up and tech transfer teams?

Submit your questions to us at urana@pharm-int.com and see them answered in a future edition of The Formula.

Cindy H. Dubin, editor of The Formula

Cindy H. Dubin is an award-winning journalist who has been reporting on the bio/pharmaceutical industry for more than 20 years. Her published work includes formulation development, manufacturing, drug delivery, QA/QC, cell and gene therapy, and more.

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