Technology transfer processes for hormonal gels require an efficient yet thorough plan, executed by skilled professionals. Finding the right contract manufacturing partner is essential. Decades of experience in technology transfers have given Orion a clear view of critical success factors that help customers reach commercial launch for their product – on time and on budget.
There are many things to consider before your hormonal gel product can be validated and commercialised. When choosing a manufacturing contractor, you’ll want a trusted partner that treats your product with the same care as you do. The technology transfer should result in a market launch, with a product of the right quality, and a process that is successfully scaled-up, validated and approved on time and on budget. So how do you get there?
During its 50 years of global experience in manufacturing hormonal semi-solids and liquids, Orion has learnt to tailor-make processes for each customer’s needs, while ensuring that they meet the regulatory standards of all the necessary global regulatory bodies. And, most importantly: the trust of customers.
Arnaud Grenier, Head of Pharmaceutical Development, Responsible for CMC Drug Product Development at Bazell Pharma, has worked with Orion in several technology transfer projects, including those of hormonal gel products, as a customer.
“At Orion, there is a deep will to achieve a successful product and to have it manufactured commercially,” says Grenier. “We have full reliability and confidence in Orion’s team.”
Through years of experience, Orion has identified four critical factors that ensure a successful technology transfer for hormonal products:
Factor #1: Get the right expertise on board
To ensure a successful technology transfer project, the contract manufacturing partner needs to gather a team of competent professionals from multiple fields of expertise.
“A technology transfer project must have an extensive team of experts aboard”, says Leif Väre, Senior Project Manager at Orion. "We always assemble a dedicated team for each customer and project. We do not only need to have the right people but also involve them at the right time. That makes a project more cost-efficient.”
In most cases, this means assembling a team that includes both pharmaceutical, technical, analytical, as well as packaging material and project management experts. Technology transfer usually requires specific process development and scale-up to reach commercial production scale. As a global provider of pharmaceuticals with extensive R&D in-house, Orion is able to offer contracting clients strong expertise in pharmaceutical process development and scale-up.
“What I appreciate about Orion is that they are not just waiting for you to tell them what to do: they are actively proposing. This really is teamwork, and if they see there is a way to make something more robust or simpler or faster, they will propose it,” says Grenier, who has previously worked with Orion in hormonal gel technology transfer projects, and currently cooperates with Orion in the Amzell AMZ001 project, which is in Phase 3. “You truly see the commitment and motivation of Orion in moving the project ahead to have it commercialized,” Grenier states.
Factor #2: Ensure the right technology and capacity for your product
Production of hormonal gels requires special production facilities that are safe for the operators and tailored to the needs of customers’ products:
“It’s very important for us to have the technology to modify scalability and capacity. We always plan processes and tune our production lines based on each product’s needs”, says Päivi Soininen, Team leader of the Commercial product development and lifecycle management team at Orion. Soininen’s team is responsible for process development and industrialization of new products.
On its Turku site, Orion has an ATEX classified hormone-dedicated manufacturing department that enables efficient and safe production. “Hormonal products are never handled in the same space as other products. Having tailor-made equipment and departments dedicated for them is crucial,” Soininen underlines.
Factor #3: Keep safety & compliance in mind from the start
To deliver a quality product means keeping all parts of the production chain per regulations. From operators to end-users, complete safety of the process and the product must be ensured.
“Safety is the top priority. With our safety capabilities, we can treat strong, potent active substances and hormones in our facilities,” says Soininen. “Safety for us is of twofold: both keeping our operators safe, and also ensuring a safe product for the end-user.”
When it comes to compliance, you want your manufacturing partner to understand the specific requirements of each market your product will be launched in. During its four decades of operation, Orion has gathered experience of all global markets – save for Antarctica – and its manufacturing sites are regularly audited by all major regulatory bodies, including USFDA and EMA as well as Japanese, Russian and Brazilian officials.
“I know that in case we would do something wrong or miss something, Orion would be working on the background and would correct and react on the matter,” says Grenier.
Factor #4: Stellar project management and continuous communication
A technology transfer for hormonal gels is a multifaceted project full of precise details and complex solutions. Tying it all up depends upon seamless cooperation and strong project management.
“Being solution-oriented is our strong suit,” analyses Väre. “Building trust with the client with active communication is imperative for us. Through our experience, we have learned that especially in the early stages of a project, open dialogue and thorough preparations are key. They lead to quality.”
Technology transfer service providers must be capable of adapting to fast-paced changes and solving unexpected problems – often under a tight schedule. You want your contract manufacturing partner to provide the best possible support.
“These projects are always about humans. The feeling you get with people. And I have to say that it has always been very easy and simple with people from Orion,” says Grenier.