New eBook: Managing Risk and Ensuring Success With a Contract Manufacturing Partner

Posted by Wellspring Pharma Services

Any long-term commercial relationship, especially between a drug innovator and its CMO, requires a number of things to remain sound: ongoing dialogue, common expectations, milestones and metrics, responsiveness, secure data access and more. With time, these relational and transactional exchanges build a collaborative bridge that pushes risk out and business success into these highly technical and complex relationships.

The question remains though, how do you get there from here?  How does a prospective drug innovator successfully and strategically assess prospective partners to ensure a long-term and successful relationship?  If you are reading this, chances are good you are pondering the same thing.  To help gain wisdom and insight, we’ve gathered together a sampling of the collective knowledge of both leading Pharma manufacturing experts and our staff here at WellSpring Pharma Services.  In this eBook, we will examine an offering of “best” advice on how to create a successful CMO partnership right from the beginning.

First Thing's First: What Makes a Successful Due Diligence When In-Licensing a Pharmaceutical Product?

In this eBook, we will explore what should go into a sound due diligence of a product acquisition 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.

What Are Feasibility Studies And How Are They Used?

Now that you have acquired a pharmaceutical product you need to develop a feasibility plan to facilitate a site-to-site technology transfer or continue on a development pathway.  A feasibility study is probably the single most important consideration in the development or technology transfer of a drug product. It’s where we begin to elucidate the formula, the process, the equipment train; where we identify the upfront variables that must be reckoned with.  A good feasibility plan should clearly state the objectives of the project and will entail a series of experiments to determine what preexisting issues may exist. In the absence of potential issues, it should identify the critical processing factors that coalesce to consistently manufacture and reproduce a quality product.

How Does FDA's Process Validation Guidance Simplify a Technology Transfer, especially for legacy products?

The technology transfer of a process, whether it is from R&D to commercial manufacturing or to another site or contract manufacturing organization (CMO) is a critical step in the lifecycle of any drug product.  In this eBook, we will explore a practical approach that addresses this complexity and propose to discuss and summarize the diverse factors required to describe the process, establish the control strategy and specify the acceptance criteria to successfully transfer a legacy or newly acquired process to another process train and satisfy the new guidance.

Ultimately, it’s simple - the better the Technology Transfer and Validation process is managed, the better its outcomes and your pharmaceutical product will be.

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Topics: E-Book, confirmation/demonstration batch, qualification, Process Development, best practices, pharmaceutical manufacturing

WellSpring Pharma Services is a full-service provider of pharmaceutical contract manufacturing and packaging outsourcing solutions for solids, semi-solids, and non-sterile liquids. WellSpring offers full-service contract cGMP manufacturing, packaging and analytical testing services from a single FDA inspected and Health Canada licensed facility.

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