A winning pediatric dosage formulation

Sponsored by Cambrex

March 6, 2019

A US-based global biopharmaceutical company known for its successful anti-infective products for adults was looking to reformulate the product into an age-appropriate dosage form for young children and pre-teen patients.

The adult formulation was well established, as was the small scale pediatric formula development, when the customer began to look for a contract manufacturing partner to manufacture dosage forms for children up to age 12.

Maintain the equipment train

Screen Shot 2019 03 01 at 2.36.09 PMThe customer established a list of criteria for selecting a CDMO partner. Among its operational priorities, it identified:

  • Maintaining as closely as possible the train of equipment used to manufacture its adult and adolescent formulations
  • Proven blending, compression, and coating capability, particularly of micro-tablets and oral granules
  • Ability to handle a variety of batch capacities: engineering, design of experiment protocol, clinical batch, registration, and validation; scaling to commercial production runs
  • International regulatory and significant commercial operational expertise
  • Expertise in cleaning requirements for low-dose formulations

The customer also wanted the CDMO to be flexible, responsive, and cooperative, and to engage in communications at the highest levels of the organization. In addition, they requested to be onsite during manufacturing to address any issues in real time.

Cambrex initially emerged as a candidate because its 226,000 sq.ft. GMP facility in Québec, Canada features the necessary equipment to handle a range of batch sizes, from 10kg to 900kg. In addition, Cambrex has in place all the quality systems to support the registration of the customer’s product in multiple markets worldwide, including the US, Canada, and throughout Europe.

Invest for the win-win

Cambrex was selected because it demonstrated flexibility, responsiveness, and cooperation. As a result, Cambrex ultimately received multiple pediatric formulation projects from the customers, in part because it was willing to make modifications and invest in new equipment to mimic the manufacturing process train for the adult formulation. For one of the projects, the customers contributed to a major investment in equipment components and modifications in the process train to more effectively contain the active ingredient.

“We were handling high value API for each batch, so having an efficient transfer system for the API and blended powder was very important

to not only transfer the product completely but also to contain the product,” said Maryse Laliberte, General Manager at Cambrex’s Québec facility.

When it was discovered that aqueous coating would not handle the necessary taste masking, Cambrex and the customer worked together to fund additional modifications to two manufacturing suites within Cambrex’s facility to allow for solvent coating of the tablets using explosion-proof technologies and new solvent coating machinery.

“It’s a win-win situation because for us, we are getting a new capability with the new XP coating, and on their side, because it was not something they could find anywhere else, they are now able to achieve the full process all at Cambrex Mirabel, including the alcohol coating for two of the pediatric products at one site,” Ms. Laliberte said.

On track

Cambrex’s collaborative approach extends to clear, joint goal setting to achieve milestones and enable the customer to file regulatory submissions within stated deadlines. The projects are all on track and Cambrex has met all of its commitments to the customer because of

manufacturing schedule flexibility, quick turnaround with documentation, sharing best practices, and drawing from the customer’s product knowledge to allow for a smooth process.

“We have been able to turn around and make the batch, or change the batch size, and deliver the product, as needed, on the days they have requested,” said Ms. Laliberte. “If our customers need to work on a fast- track project, we are equipped and we have the team to deliver.”

Measuring success

Cambrex is measured by the customer against key performance indicators based on the speed of its execution, compliance with quality systems (Cambrex’s and the customer’s), the quality of its work, and its ability to resolve issues quickly and with transparency.

The customer has been so pleased with its relationship with Cambrex that it has deemed the CDMO its main pediatric manufacturer and has extended the products placed at Cambrex for other adult formulations/products.

“They see us as an extension of them, not only as a service provider,” Ms. Laliberte said of the customer. “We have built a relationship where both teams – theirs and ours – exchange best practices to achieve the goals of both companies.”

Download the Cambrex case study