Wellspring Pharma Services

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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Recent Posts

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.

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

Bordering on Myth: Controlled Substances and the Canadian Border

Posted by Wellspring Pharma Services

There is a common misconception that controlled substances won’t be allowed to cross the Canadian border, thus preventing some pharmaceutical products from being produced by Canadian contract manufacturing facilities. We need to move past this fallacy. There are many proven ways to manufacture controlled substances in Canada, provided the products are in compliance with import/export regulations in their home nation. Even if the substance is banned in Canada, Canadian regulators permit such commerce to proceed with minimal bureaucracy and legal red tape.

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Topics: production, CMO Partner, exports, open market, imports

What Is The Difference Between Method Verification And Method Validation?

Posted by Wellspring Pharma Services

Clients have come to us in the past asking "We need 'method validation'.” Sometimes they'll use the term “validation” or “verification” but it seems apparent they're not really clear on what the difference is between the two. For the most part it’s not that well-known that method validation is a much more rigorous process. What’s really needed, more likely, is the establishment of a verification regime that assures analytical methods perform reliably, accurately, and precisely for its intended application.

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Topics: Quality & Regulatory

Good Manufacturing Practice: The DNA of Pharmaceutical Quality

Posted by Wellspring Pharma Services

Good Manufacturing Practices or GMP's are the pharma industry’s fundamental guidance set up by regulatory authorities to describe what is necessary to manufacture safe, effective drugs. Essentially, GMPs (referred to as current Good Manufacturing Practices or cGMPs in the U.S.) provide a framework of manufacturing best practice standards that pharmaceutical processors are compelled to adopt and incorporate into their drug-making processes.

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Topics: Quality & Regulatory

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

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

What Are My Options For Reducing My Pharmaceutical Product Manufacturing Costs?

Posted by Wellspring Pharma Services

We’re often presented with the challenge of reducing the manufacturing costs of a pharmaceutical product. There are several avenues to take in reducing your product costs - so let's take a look at a few areas that can be re-evaluated for potential savings.

Look At Your Individual Raw Material Costs, And How They're Supplied

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Topics: Quality & Regulatory

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

How Do You Choose The Right Contract Manufacturer For Your Pharmaceutical Product?

Posted by Wellspring Pharma Services

Pharmaceutical companies face a critical decision in choosing the right contract manufacturer for their product's success and ultimately for their company’s performance.

While price is an important consideration, there are many other factors to consider, and in our experience, we have found that it may come down to a lot more than who can manufacture most economically.

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Topics: Quality & Regulatory