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

What Makes a Successful Due Diligence When In-Licensing a Pharmaceutical Product?

Posted by Wellspring Pharma Services

When a company is looking at acquiring or in-licensing a pharmaceutical product, there are a few technical factors that should be carefully considered before the deal is completed.  Navigating through all of the technical documents can be very time consuming and confusing.  The technical parameters that a company needs evaluate can be complex.  You need to glean as much technical information as possible on the manufacturing and packaging process itself as well as from Quality Control, Quality Assurance, Regulatory, and Logistics of a pharmaceutical product.  

You should go into the product due diligence with a detailed checklist to ensure you leave no stone unturned.  The goal, of course, is that you come out of the due diligence process fully aware of all the issues and potential issues of acquiring a pharmaceutical product – new or existing.  We've seen some clients acquire new products thinking everything was great, only to find out, for instance, that their methods were not USP standard methodologies, even though their plan was to market the product as USP standard.

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Topics: Manufacturing Scale-Up

Developing an Effective RFP (Request for Proposal) Process for Your Pharmaceutical Product

Posted by Ron Herman

More and more, pharmaceutical companies are outsourcing the manufacturing and packaging of their products.  With the increased use of Contract Manufacturing Organizations (CMO’s), the need for an effective and well-designed Request for Proposal to effectively communicate your organization’s needs and timelines is essential to ensure you and your CMO are on the same page when it comes to your project needs.  Ron Herman has been advising pharmaceutical companies for many years and has a lot of experience with writing effective RFP’s.  Since we get a lot of questions from our customers about this topic, Ron has graciously agreed to write an article for us and share his experiences with writing effective RFP’s.

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Topics: Manufacturing Scale-Up

What Considerations Should Be Made When Planning A Feasibility Study?

Posted by Wellspring Pharma Services

When developing a drug product, feasibility studies are significant in fine-tuning your processes from the formulation stage to the final production stages. These studies give opportunity to confront potential process variables for either new products or existing. Overall, mapping out a feasibility plan can improve inefficiencies in the process and equipment train. To start, clear objectives of the project must be clearly identified, and from there, a series of experiments must be put into place to test out what pre-existing issues may be present. In the absence of potential issues, it should identify the critical processing factors that coalesce to consistently manufacture and reproduce a quality product.

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Topics: Manufacturing Scale-Up

How Much Does It Cost To Make A Pharmaceutical Tablet Product?

Posted by David Watt

Pharmaceutical companies frequently ask us this question: how much does it cost to manufacture a pharmaceutical tablet? The real answer is: it depends on many factors. We need to truly understand the detailed specifics of the pharmaceutical company’s objectives and requirements for the product, with respect to manufacturing, packaging, testing, and regulatory submission in order for us to address cost in an intelligent and realistic manner.

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Topics: Manufacturing Scale-Up

5 Key Factors That Contribute To Price Differences Between Tablets And Creams In Drug Manufacturing

Posted by David Watt

Pharmaceutical companies frequently ask us this question when they have a multi-dosage form portfolio they want us to provide a quotation or scope of work on. The answer to this question is multi-faceted in that there are a number of questions with regard to materials, process, and testing requirements that need to answered.   

Armed with those answers, we can examine and factor the responses into a determination of the commercial cost to develop either a tablet or cream process.

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Topics: Manufacturing Scale-Up

What Can Project Managers Do To Ensure a Smooth Start to a Pharmaceutical Product Technology Transfer?

Posted by Dara Caratao

A prospective client often asked, "What can we do on our end to ensure a smooth technology transfer to your contract manufacturing facility?" Getting asked this question is great, because ultimately, a contract manufacturing facility will rely on key insight from the client in terms of what is expected for their technology transfer.

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Topics: Manufacturing Scale-Up

How Much Does It Cost To Make A Pharmaceutical Product?

Posted by Wellspring Pharma Services

Pharmaceutical companies frequently ask us this question: how much does it cost to make a pharmaceutical product, such as a tablet, capsule, cream, lotion, gel, ointment or oral liquid? The real answer is: for any of these types of products, it depends.

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Topics: Manufacturing Scale-Up

What Does It Cost To Perform A Technology Transfer?

Posted by Wellspring Pharma Services

Whether it be to augment your manufacturing capacity or provide resources for commercial manufacture and launch, you have been looking for a Contract Manufacturing Organization for some time, and ask: what is the cost of a technology transfer?

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Topics: Manufacturing Scale-Up

What Is The Difference Between a Glatt and a GEA-Niro Fluid Bed Granulator / Dryer?

Posted by David Watt

Many clients will come to us and have a specific type of fluid dryer that they’re using at their own facility or the facility at which they get their product manufactured. Typically, the fluid bed dryer will either be manufactured by Glatt or GEA Niro. A common client concern we address involves moving from one brand of FBG/FBD to another. The big question is – what are the main differences between these brands of equipment?

The correct answer is - there really is no difference between them. GEA Niro and Glatt are two different both world leading manufacturer’s of similar types of processing equipment for the production of powders, conglomerates and granulates. Basically, it’s more of a company preference than a performance choice.

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Topics: Manufacturing Scale-Up