Relationships are difficult to navigate effectively. One party often feels the other is taking advantage of the situation. Things are left unsaid. Things that are said are often not meant. Disagreements may occur.
Such is the world of technology transfer for pharmaceutical contract manufacturers.
Technology transfer involves the efficient transition of technical and manufacturing capabilities between separate entities. Developing and manufacturing pharmaceuticals is an exacting process requiring scientific, regulatory and operational expertise within the manufacturing facility for successful commercialization. Transferring technology to another entity adds additional potential obstacles to be overcome.
WDPrx, a pharmaceutical contract manufacturer specializing in liquids including oral solutions, suspensions, syrups and semi-solids, involves a dedicated team of laboratory scientists, production technicians and regulatory experts for each tech transfer project. With different companies involved, each with their own culture and established procedures, detailed step-by-step responsibilities must be developed and agreed to avoid misinterpretation leading to delays.
According to Adam Runsdorf, WDPrx President, “Over the course of 30 years of operation, WDPrx has established a reliable system for technology transfer. From initial contact progressing through large-scale manufacturing and pharmaceutical laboratory testing, our protocol stresses scientific requirements and positive personal interactions with all involved parties to assure successful outcomes.”
The challenges when working with virtual manufacturers are often heightened because there may be a lack of complete historical data about the product involved with the transfer. Some virtual manufacturers may rely on expertise from the contract manufacturer about scale-up and other pharmaceutical development and manufacturing areas to enable a streamlined transition to the production site.
Three Steps For Success
Although each transfer involves a unique set of circumstances, WDPrx follows three general guidelines that help assure a successful tech transfer relationship.
At each stage, the best commercial manufacturing organizations set themselves apart with high levels of communication, accountability, planning and experience.
- Get Acquainted –
Define the elements of a successful project at the start and determine expected final outcomes; develop a checklist; examine original formulations, analytical methods and production methods; review original equipment to confirm whether modification in the new facility is required; examine training procedures to assure clear understanding of individual and team responsibilities
- Develop Trust –
Seek input from previous manufacturer if available to reduce cost and gain information helpful during the production process; analyze documentation for completeness and up-to-date production records; evaluate SOP protocols concerning processing, packaging and cleaning; confirm analytical testing methods meet SUPAC guidelines; conduct packaging line trials and a comprehensive health and safety review; check every process prior to preliminary engineering runs and scale-up
- Complete The Task –
Confirm original success parameters are addressed and resolved; create a support team for manufacturing with direct access to all materials and notes pertaining to the technical transfer; implement a mutually agreed-upon statement of work; regularly consult with original team members to maintain course and keep lines of communication open.
There are many challenges to organizations involved with technology transfer of complex documentation and proprietary procedures. An important factor determining success relies on the ability of both parties to overcome practical and also the inter-relational elements of the project. Many contract manufacturing partners can handle the hard scientific challenges of tech transfer. The most overlooked ingredient to success is the attention paid to the soft emotional skills. Mastery of these soft skills including patience, motivation, empathy and self-awareness can make or break the relationship between technology transfer parties.
The science and the psychology of technology transfer are bridged by frequent and transparent communication throughout the project timeline. Adds Runsdorf, “Delays in the transfer process can occur due to lack of communication, misinterpretation and misperception. Most of these are avoidable with thoughtful and detailed consideration of all parties to overcome challenges and earn client satisfaction.”
For further information about technology transfer at WDPrx – Woodfield Pharmaceutical, LLC, go to: https://www.wdprx.com/contract-manufacturing/development/
WDPrx – Woodfield Pharmaceutical, LLC is a proven and reliable contract manufacturing specialist across a range of delivery methods including oral solutions, liquid solutions, suspensions and semi-solids. Capabilities include Research and Development, Material Procurement, Manufacturing, Process Optimization, Formulation, Pharmaceutical Validation, Pharmaceutical Laboratory Testing and Pharmaceutical Analytics Services.
Contract packaging operations handle liquid and solid-dose configurations.
The modern facility is dedicated to the highest levels of quality pharmaceutical manufacturing. Based in Houston, TX, WDPrx is cGMP compliant and utilizes advanced technology to support full Technology Transfer and System Integration for minimal production down-time.