Part 5 — The Cost of Getting a Technology Transfer Right

Posted by Norm Fong

Technology Transfer: Want To Get It Right?

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 5 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: Regulatory site audit, legal fees, capital expenditure, MSA, QA, confirmation/demonstration batch

Part 4 — How are Analytical Methods Exchanged in a Technology Transfer?

Posted by Norm Fong

Technology Transfer: Want To Get It Right?

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 4 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: CMO, analytics, analytical method transfer, chemical analytics, validation

Part 3 — The Role of Project Management to Ensure a Smooth Technology Transfer

Posted by Dara Caratao

Technology Transfer: Want To Get It Right? 

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 3 of an in-depth, multi-part series on tech transfer.  Visit our blog page to view additional segments.]

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Topics: CMO, tech transfer, sponsor, RFQ, kickoff meeting, project management

Part 2 — The Ins & Outs of Technology Transfer

Posted by Norm Fong

Technology Transfer: Want To Get It Right? 

[Editor’s note: Success in contract pharmaceutical manufacturing hinges on several critical factors, but chief among them is getting technology transfer right. This is part 2 of an in-depth, multi-part series on tech transfer. Visit our blog page to view Part 1.]

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Topics: CMO, technology transfer, process design, GMP, quality controls, scale-up

Part 1 — What is a Technology Transfer and How to Ensure a Successful Transfer

Posted by Norm Fong

Technology Transfer: Want To Get It Right? 

Current market conditions, as well as a myriad other factors, have increasingly prompted drug developers to establish complex supply chains to ensure the commercial-scale manufacture of the compounds they’ve created. Perhaps one of the most important links in any contemporary supply chain is the one between drug owners and the contract manufacturing organizations (CMOs) they partner with to ensure that supply will meet the demand for their therapies. When it comes to these relationships, success hinges on several critical factors, but chief among them involves getting a highly critical process right: the technology transfer.

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Topics: technology transfer

Implementing a Change Control Process - Part 2

Posted by Anelis Aurand-Araos

At WellSpring, as with any other pharmaceutical manufacturing company, we developed a change control policy to ensure that any proposed changes to product or processes were thoroughly examined before they were implemented, and that no unintended consequences would result. As we are currently reviewing and updating our policy, we felt that sharing our methodology would be illustrative of our process and instructive to others who need better processes. 

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Topics: Change control process, change management, change control committee, QA

Implementing a Change Control Process - Part 1

Posted by Anelis Aurand-Araos

Change control is a systematic approach used in many industries to manage all changes made to a product or process. This is particularly important in the pharmaceutical industry, specifically as it applies to pharmaceutical manufacturing where the complexity of the tasks to be performed during manufacturing, packaging and analytical release testing require detailed documentation of each task. Any changes in how those tasks are performed or managed need to be illustrated and justified through a change control. In Part 1 of a two-part blog, we’ll look at the change control process in general, discuss some of the basic principles and review some of the changes in pharmaceutical development and manufacturing that require following a change control process. In Part 2, we will discuss the steps to implement such a process.

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Topics: Change control process, change management, Quality Unit (QU), RACI

Principles of Technology Transfer

Posted by Norm Fong

In the context of contract drug development and manufacturing, transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacturing sites.” It is the systematic procedure that is followed to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible party.

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Topics: Manufacturing Scale-Up, technology transfer, site-to-site, site-to-CMO, site transfer

Creating a Culture of “Quality Beyond Compliance”

Posted by Anelis Aurand-Araos

If your job is to develop and produce medicines to prevent disease and mitigate suffering around the world, quality is the guiding principle of your business model.

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Topics: quality, Corporate Culture

Canada’s Winning Business and Regulatory Climate

Posted by Sam Ricchezza

Doing business in Canada offers tangible business benefits. In any country, contracting contract manufacturing services requires managing the legal and regulatory aspects particular to that country; fortunately maintaining a commercial relationship across Canadian borders is generally simple and straightforward. Canada offers pharma companies an ideal platform from which to access European and other markets as part of an international business strategy. 

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Topics: CMO Partner, open market, regulation, innovation