Case Study: Tech Transfer of a 1.0-gram Hygroscopic Powder Sachet

Case Study: Tech Transfer of a 1.0-gram Hygroscopic Powder Sachet

Fri Dec 3, 2021

Introduction

Technology transfer is the hand off of process and product knowledge between development and manufacturing, or from one site to another. The transfer of manufacturing processes, analytical procedures and packaging between facilities or laboratories is an essential part of pharmaceutical development and commercialization today. The role of a CMO is ever evolving and their customers’ demands are driving CMO’s to adapt their services, facilities and technical capabilities to meet current regulatory, quality and consumer requirements.

A technology transfer will take all the existing inputs and outputs of a process or method development activity and transfer that knowledge to a new location or CMO where a manufacturing process or analytical procedure will be validated and performed. A crucial piece to the overall success of a technology transfer or tech transfer, is the process of manufacturing to primary packaging critical path of the pharmaceutical product.

The requirements for tech transfer are mandated by the FDA’s Scale-Up and Post-Approval Change (SUPAC) guidelines.

SUPAC requires that when a drug is made at a new location, every aspect is virtually identical to the drug and the process for manufacturing it at the original location. These include the ingredients, formulation, packaging, manufacturing procedures, testing and equipment train.

Sonic Packaging Industries works with both branded and generic pharmaceutical companies to execute successful technology transfers for their oral, topical and subcutaneous drug products.

 

Meeting the “Tech Transfer” Challenge:

A pharmaceutical company contacted Sonic Packaging with a specific and urgent product need. The project:  Transferring their branded product, an oral antibiotic hygroscopic powder suspension packaged in individual 1.0-gram unit dose sachets, from an existing site to the Sonic Packaging pharmaceutical manufacturing facility.

Sonic’s tech transfer process begins with an assessment of the overall project scope from API to excipients, manufacturing, analytical methods, packaging method transfers, and documentation from our clients. Our Sonic team then develops a detailed tech transfer proposal along with a transfer package that includes a thorough gap analysis and risk assessment. The result of these steps is a comprehensive tech transfer plan and timeline that is submitted to the client.

With all tech transfer projects and critical path pharmaceutical development programs, Sonic Packaging assembles an integrated, interdisciplinary team with our cross functional experts in Operations, CMC (Chemistry, Manufacturing and Controls), Supply Chain, Analytical, Quality, Engineering and R&D. Clear roles and responsibilities of the development group and transfer site personnel are defined and communicated to the client.

Weekly team meetings, shared networking platforms and planned interval reviews of KPI’s and timeline milestones were crucial to keeping the teams on task and updated for the 1.0-gram sachet project.

For our client’s oral antibiotic tech transfer, Sonic needed to ascertain that we had a well understood robust process, corresponding analytical methods, identification of the critical process parameters (CPP) and a well-designed equipment train prior to commencement and execution of the transfer plan. Having over 25 years’ experience in manufacturing and packaging, Sonic easily identifies one of the most important, but often overlooked considerations in a tech transfer project, ensuring our CMO facility is the right fit or match for the client’s project.

Tech transfers require duplication of packaging methodologies and materials used at the original manufacturing site. Sonic’s client had a 1-gram sachet which required a very specific packaging platform with critical product dosage requirements when the patient or medical professional dispensed the package. Sonic duplicated the critical process parameters and protocols, reviewing the existing equipment train and comparisons. SUPAC requires that, within reason, the equipment at the new location is the same size, class, and sub-class as the original CMO

Comparing each production line side by side, be it batching or packaging, in accordance with SUPAC guidelines, enables identification of any potential differences and what effect these differences, if any, have on the identity, quality, safety, purity or potency of the finished pharmaceutical.

As part of the gap analysis for our client’s sachet project, Sonic determined that a specific series of compound blenders were required as well as HEPA filtration and environmental dehumidification   Sonic arranged a reverse purchase of this equipment which enabled the customer to recover their upfront capital over the first 12 months of production.

When outsourcing a tech transfer project to Sonic Packaging, pharmaceutical clients typically come to us with clear specifications for all raw materials. Our clients will often share and engage their existing raw material suppliers with Sonic so the transfer sites can continue to source all the same ingredients from the same active ingredient supplier thereby maintaining the same specification, lead time and cost structure.

 

Tech Transfer Success

To ensure your tech transfer meets regulatory requirements and exceeds timeline expectations you must select a CMO facility that has the infrastructure, resources and knowledge base to develop and execute successfully.

Sonic was able to meet and exceed our clients’ expectations on their 1.0-gram oral antibiotic hygroscopic powder suspension sachet. After a successful FDA submission, the client was able to expand their market share and brand identity within the U.S.

For Sonic’s client, having the process batching, testing and packaging equipment facilities in one location made continuous manufacturing very feasible, reduced supply chain complexity and lowered logistics costs.

Over the first 7 months of production, Sonic Packaging achieved a 10% increase in yield for finished packaged product from batch to batch compared to the client’s internal pharmaceutical facility.

 

Key Takeaways

When a pharmaceutical company wants to outsource or partner with a contract manufacturer, such as Sonic, here are some of the things a client should look for and remember when selecting a CMO for a technical transfer:

• Has the contract manufacturer been successful with prior FDA submissions?
• Do they have experience with successful tech transfers for similar pharmaceutical products?
•    A successful tech transfer works best when there is close communication and complete information sharing among the sponsor, sending manufacturer (previous CMO or plant), and receiving manufacturer.
•    The client and CMO should be clear on the sponsor's business goal, milestones and overall timeline.
• Your CMO must have the regulatory knowledge, robust quality culture and experience to guide the tech transfer pursuant to the current FDA regulations.
• Thorough evaluation of the product specifications and analytical test methods against the current or new USP requirements must be done at the initiation of the tech transfer process.
  
  

About Sonic Packaging

Sonic Packaging Industries Inc. is an ISO 9001:2015-certified contract manufacturing and turnkey packaging solutions provider specializing in single-use and metered dose delivery systems. Plants are FDA-registered for medical device and drug products as well as ISO 13485 and ISO 9001 certified.