CPL success story: From tech transfer to FDA approval
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CPL success story: From tech transfer to FDA approval

27 Jul 2021

Sponsored by CPL Sponsored by Visit Company
CPL success story: From tech transfer to FDA approval

From flexibility and manufacturing capacity to cost savings and specific expertise, there are so many reasons pharmaceutical companies both big and small choose to work with contract development and manufacturing organisations (or CDMOs). After selecting a CDMO, many projects entail a technology transfer of the product from one site to the CDMO for further activities. But no outsourced project can excel without a smooth technical transfer process, and choosing a CDMO with a track record of success is key to stopping thorny handovers from overcomplicating and delaying your project.

One CDMO with a strong history of success is CPL. The Canadian-based company has more than thirty years of experience helping global pharmaceutical companies develop, manufacture and package non-sterile liquid and semi-solid formulations. Customers typically approach CPL for a range of product needs, whether it’s to manufacture a commercially approved product or to support the development of a new, innovative formulation from the early concept phase all the way through clinical trial studies and regulatory filing.

Ultimately, customers leverage CPL’s capabilities and facilities to address their gaps and fill a need without having to make significant investments of time and money in people, facilities and equipment. CPL’s years of experience delivering projects from start to finish (and everywhere in between) means the team has handled a significant number of technical transfers, and according to CEO Ken Paige, this expertise is something it can bring to its customers.

“We anticipate the key issues we’ll need to address when somebody transfers a commercial product to us, and we’ve got the expertise, facility and equipment to ensure we make those commercial transfers happen in the most expert and expeditious way, with the least risk,” Paige explains.

A CPL case study

CPL’s strategic decision to focus on the non-sterile liquid and semi-solid dosage form makes the Canadian company a top choice of partner for customers developing these products. That’s why, when a company needed a CDMO to support the product development and clinical supply of a complex nasal spray product, CPL was the perfect partner for the project.

After a highly competitive process involving months of meetings and due diligence, CPL was awarded the project due to its experience with the dosage form. Crucially, CPL had the necessary manufacturing capacity, flexibility, knowledge, and creativity to transfer the product into its operation and develop a robust manufacturing process to produce a top quality product at commercial scale. CPL’s willingness to work with the company hand in hand, and thus build a long-term relationship that would support the customer’s future requirements, was another key decision factor.

CPL’s product development team began the technical transfer from another CDMO – a company that had been working on the project previously but who lacked the expertise to support the process development and provide commercial product supply.

Many pitfalls and issues can arise during the product development process, and an experienced team is required in order to foresee and avoid or mitigate these. Throughout the tech transfer, CPL identified several formulation challenges, and developed a workable, long-term solution that significantly improved the way the product was made.

Transferring between development and commercial production stages is another critical step where problems can arise and risks are high. This is often experienced by companies who outsource development and manufacturing to separate companies, rather than leverage the full-service capabilities of a CDMO like CPL. Because CPL’s development team and commercial operations team work from the same location, the two teams were able to collaborate closely to ensure a seamless transition.

The product itself had a complex filling and packaging process which required certain equipment that neither the customer nor CPL had at the time. As a result of its long-term partnership with the customer, CPL recognised the opportunity to co-invest in a new filling line to ensure consistent commercial supply. Under the agreement, CPL managed the equipment vendors and oversaw the installation, layout, and qualification of the equipment within its facility, which freed up the customer to focus on their clinical trial and regulatory demands. With the successful installation of the new filling line, CPL was ready to meet the nasal spray’s complex packaging requirements and prepare for commercial launch.

However, the product also had difficult testing requirements that needed to be met. CPL’s analytical expertise and experience working with nasal spray products enabled the company to develop robust testing methods and utilized specialised testing equipment to provide consistent and repeatable product testing.

The manufacturing process improvements and new filling equipment allowed the customer to prepare the product application to the FDA for approval. During this process, CPL and the customer undertook multiple process and packaging validation studies in support of an optimised regulatory approval timeline. Additionally, CPL prepared to host the FDA for a Pre-Approval Inspection which was ultimately successful and allowed the product to launch according to plan.

When the product received FDA approval, CPL was positioned to support its launch. The company’s commitment to always ensuring the highest levels of product quality and regulatory approaches ensured a successful commercial launch and an excellent product, creating the perfect foundations for a longstanding relationship with the customer.

To find out more about CPL’s commercial manufacturing and product development expertise, go to www.cplltd.com to learn more or to contact them to discuss your project details.

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Development of topical semi-solid products and significance of Critical Process Parameters (CPP) studies

The semi-solid dosage form is comprised of creams, gels, ointments and lotions. These are typically multi-phasic formulations and are made of complex structural elements. The complexity of the dosage form means that there is a high risk of failure during formulation planning and manufacturing scale-up. To reduce this risk, careful consideration of a range of Critical Process Parameters (CPPs) is a necessity. Heating ranges, mixing speeds, and kettle geometry, for example, are each of vital importance.

Contract Pharmaceuticals Limited (CPL) is an experienced CDMO dedicated to the research, development, manufacturing and packaging of topical semi-solid and liquid pharmaceuticals. In this recorded webinar, Chetan Chure, Manager of Formulation Development at CPL, shares his advice on the development of topical semi-solid products. Taking a scalability perspective, the webinar focuses on the importance of integrating CPPs into the selection of ingredients, manufacturing processes, and equipment.

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