Re-thinking Aseptic Filling – Innovations for Pharma’s Challenging Requirements

Introduction

The challenges for aseptic filling operations in support of pharmaceutical product development programs continue to mount. Smaller run volumes, ever increasing varieties of drug types, higher standards of quality and precision, a variety of dosage forms, and more pressure to reduce development times are just a few of these demands. Pharmaceutical contract service providers with injectable fill-finish operations and associated supporting industries must proactively drive the changes necessary to meet these challenges. This webinar discusses several technological advancements and a new service model that can provide enhanced flexibility, responsiveness, and dependability needed to meet these industry demands for aseptic filling.

Injectable Filling – Pharmaceutical Product Development Requirements and Gaps

Major challenges and gaps exist in current contract service aseptic filling capabilities and can often be frustrating to industry personnel in positions within C-Levels, Pharmaceutical and Product Development, CMC, Manufacturing, Process Engineering and Technology Development, Procurement, Purchasing and Supplier Management functions. These challenges include:

• Increasing number of smaller product volumes – higher numbers of targeted treatments for smaller patient populations
• Shortage of small volume fill services – large CMOs/CDMOs want large volume product manufacturing opportunities
• Continued pressure to reduce time to market
• Continued pressure for more precision (e.g. fill volumes) and higher quality standards (e.g. less particulates)
• Simultaneous development of multiple drug products
• Requirements for a variety of dosing forms – vials, syringes, cartridges
• Long lead times for filling
• Drugs that are expensive, scarce, and can’t tolerate much line loss

These pressures and needs are causing pharmaceutical companies to look for greater flexibility from injectable fill-finish operations. CMOs and CDMOs are being called on to adapt accordingly.

Re-thinking and Innovation

By re-thinking current aseptic filling practices, and then identifying and applying innovative new technologies and new service models, contract service providers can meet these challenges and requirements.

Service Model

<align=justify>Armed with the advantages of innovative automation and materials handling capabilities, an aseptic filling service provider can establish a specialized service model in providing efficient, small volume runs with shortened lead-times. Fill volumes of several thousand pieces can be performed in a single shift (depending on fill volume per unit) including set-up and clean up for the next run. The use of pre-qualified automated process set-up parameters and standard component material presentations allows efficient product changeovers. Innovative supply chain practices can be implemented to manage product pathway parts, container components and tooling allowing reduction of traditional lead- times. With additional services such as formulation development for clinical trials, the filling service provider can be more flexible and responsive to client needs.

Technical Innovations

In the realm of aseptic filling, there are several innovative technologies and technical approaches that once applied, will enable CMOs and CDMOs to meet the challenges. There have been recent advancements in the design approach to aseptic filling processes with some novel features. These advancements are the result of re-thinking existing processes, reviewing lessons learned and applying new, innovative ideas and technologies.

Filling platforms such as the SA25 Aseptic Filling Workcell from Vanrx Pharmasystems Inc., now offer completely integrated processing to manufacture dosages in vials, syringes and cartridges in a single, compact system. The SA25’s ability to adapt to a variety of dosage forms and batch sizes results in minimal downtime for product changeover. This high level of adaptability is achieved by utilizing specially designed automation tools integrated within a closed isolator system. These systems offer improved product quality and precision.

The use of nested components (vials, syringes, cartridges, stoppers and caps) simplifies material flow within the system. In addition, the nested components configuration eliminates sources of particulate due to the absence of tooling and machinery for vibratory bowls, accumulators, and conveyors used in traditional systems.

Pre-sterilized, plastic press fit vial closures can also be procured in standard, nested matrix formats from well-known and respected suppliers. These components allow the vial stoppering and capping process to occur without ever leaving the sterile environment of the isolator.

The use of pre-sterilized, disposable product contact path materials (e.g. bags, tubing, sterile connections) reduces material cross contamination, and speeds product changeovers by eliminating extensive system cleaning.

Summary

In response to changes in the pharmaceutical market, CMOs and CDMOs must provide new service models that accelerate drug development times for drugs made for smaller patient populations. This webinar will explain how Singota Solutions has created a service model that integrates new technologies for aseptic fill-finish with upstream and downstream support services. The resulting model benefits pharmaceutical companies looking to increase speed to market and flexibility for either clinical or small volume commercial injectables.

Speakers

Brent Lieffers, Senior Director of Operations, Singota Solutions

Brent Lieffers in the Senior Director of Operations at Singota Solutions. Brent has 24 years of Pharmaceutical industry experience, spanning from API manufacture through final drug product packaging, in operations ranging from small clinical to large commercial scale production. His roles in multiple startups have included regulatory submission preparation, technology transfer, equipment expertise, process optimization, process investigations, and both regulatory and client inspections. Prior to joining Singota Solutions in 2013, Brent was the Director of Manufacturing at a large parenteral formulation/fill/finish facility.

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John Harmer, Director of Sales, Vanrx Pharmasystems

John Harmer is the Director of Sales for Vanrx Pharmasystems. After more than 25 years in the Pharmaceutical industry, he has experience in just about every aspect of drug development and manufacturing. In addition to aseptic filling, John has worked in API production and process development, device development, clinical trial logistics, and regulatory submissions for novel therapeutics. John understands the timelines and challenges of the drug development process and is a valuable technical resource for Vanrx’s customers.

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