Monday, November 2, 2015

Cell Therapy Manufacturing Best Practices from PCT

This article is the second in a series of weekly posts featuring cell therapy news and articles as reported by BioProcess International Magazine. 

By: Leah Kinthaert

In the October 15 issue of BioProcess International, a group of industry thought leaders consisting of Bob Preti, Ann Daus, Cenk Sumen and Brian Hampson from PCT - Caladrius were asked to give their opinions on the most successful strategies for manufacturing in the cell therapy industry.

Best practices for commercial cell therapy manufacturing
The team states that implementing DbD or Development by Design, consisting of these facets: quality, cost of goods, scalability and sustainability (picture above), will "provide significant cost and time advantages as a cell therapy moves along in its clinical process".

Compliance at cell therapy manufacturing facilities
A foundational state of compliance entails that people, facilities, systems and processes are unified in compliance, and that a QTF or quality task force is created  which includes "representatives from manufacturing, operations, and quality groups, with different areas of industry experience." They caution cell therapy developers not to wait to worry about quality until something has gone wrong - such as delays or regulatory actions - but to have the QTF in place from the beginning.

Develop QTPP early
The team gives another strong message about preparation when it comes to QTPP or quality target product profile. As with QTF, waiting to develop a QTPP can lead to problems.

Strategic Commercial Manufacturing Plan
One last acronym they recommend is a SCMP or strategic commercial manufacturing plan. Keeping with the theme of planning the future to avoid potential problems, a SCMP needs to include: "an evaluation of a developer’s current manufacturing processes; an analysis of those processes for areas of potential optimization and improvement; and a practical, implementable strategy to take a process from its current state to a future, commercial-ready state while reducing risks." You can read the entire article here.

PCT - Caladrius in the News: 
In his opening remarks at the BioProcess International Conference Cell Therapy Pre-Conference Symposia, Chairperson Kurt Tisler showed a map of the US with a handful of companies on it. The map included "Cell Therapy CMO Options in the US" and PCT was one of only 3 private companies and another handful of institutions that were options for Phase III in cell therapy. The map gave a striking picture of just how much those companies are in the forefront of cell therapy manufacturing. The past two months have been eventful for this industry leader, with news on multiple fronts. What follows is a brief run-down of noteworthy news about this organization.

PCT supporting IRX's development of IRX-2
PCT is providing IRX "with personnel and dedicated clean room capacity within its current cGMP infrastructure and pursuant to EU cell therapy manufacturing standards.” Caladrius is the only cGMP-compliant cell therapy manufacturing provider that has facilities on both the East and the West Coasts. Additionally they are the only one to see a client's cell therapy product receive approval from the FDA for commercial sale.

PCT has entered into a collaboration agreement with Sanford Research to develop CLBS03
The initial focus will be the execution of a clinical trial to evaluate the safety and efficacy of CLBS03 in adolescents. The Phase 2 study has an open and active IND; subject enrollment is expected to commence the first quarter of 2016.

NIH's National Cancer Institute gives $300K in funding, with a potential $2 million to follow
This will fund the first phase process optimization of Caladrius' therapeutic agent targeting tumor-initiating cells. The $2 million in funding is to be expected in June 2016 if both the government and Caladrius agree to proceed at the conclusion of the first phase.

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