Over the last few years, biopharmaceutical-processing platforms moved from rigid traditional stainless steel to flexible single-use technology. The platforms created the ability to run the process more efficient and with higher agility. The need to evolve from fixed and rigid to flexible and agile systems did not stop with processes, but now shifted focus to facility designs.

Traditionally the facilities built, were product dedicated, large if not convoluted and involved lengthy time-to-run periods. New plug and play, lego format, facility designs are required to be able to create facility flexibility.

The paper will present such plug and play options, production process platforms, which can be employed fast track and with high degree of flexibility. It will scrutinize the options and the feature and benefits of new modular designs, which can be assembled to entire processes or kept as unit operation.

Times are changing, product pipelines are making drug manufacturing processes more complex and at mixed high and low volumes.

The opportunities to add adaptive manufacturing capability, enabled by new ready to use sterile components such as vials, cartridges and syringes, will lead to the manufacturing of drug product in smaller footprints with reduced infrastructure requirements.

These new RTU components have some challenges that require early engagement with the suppliers to ensure success at commercial scale. This presentation will review the challenges of visible particles in new RTU systems and how to partner early and ensure success.

The use of ready to use (RTU) primary packaging materials (PPM) in aseptic filling is gaining popularity among drug manufacturers. To make the change from traditional PPM preparation to RTU on existing equipment can present challenges including process changes, equipment retro-fitting and new handling tools.

Vetter Development Services Chicago is a CDMO offering clinical cGMP aseptic filling for vials, syringes and cartridges and has recently executed this process change in order to use RTU vials on an already existing filling line.

This presentation will discuss the challenges encountered when developing the process and the solutions that were implemented to achieve success.

It will also describe the manual process steps followed to ensure sterility while introducing the RTU vials to the filling equipment. This RTU process has been in effect for just over a year and has been validated via multiple mediafills.

Companies are looking to decrease the time required to bring drugs into clinical trials and also to reduce the capital investment costs. Building a new facility for filling requires a large amount of capital expenditure and also requires a lot of time.

One way to effectively reduce the capital costs and to decrease the time to start up a new facility is through the use of disposables. The use of disposables is highly popular in the Drug Substance process and is gaining popularity in the Drug Product process.

Another method of reducing capital costs and decreasing timelines is by building flexibility into your filling equipment and also outsourcing some of the non-core tasks. The installation of a flexible modular Isolator filling line reduces the capital cost by allowing for one Isolator to be installed for two separate filling lines with the capacity to supply clinical trials and commercial launch material demands.

The presentation will describe the layout of the flexible modular Isolator filling line and how it incorporates the use of ready to use vials.

Prefilled syringes are industry's choice of platform for further innovating your product and adding value. With biological drug products being so complex, a huge amount of consideration needs to be taken regarding delivery method, design of primary packaging, device and analysis of product stability, safety and efficacy.

A system approach is needed because of the interaction between the biodrugs unique features (i.e. viscosity), drug delivery devices, such as autoinjectors, and syringes different geometries and elemental compositions.

All these are critical aspects that need to be carefully evaluated in order to guaranteed an effective, safe and painless injection to the patient.

This paper will highlight how to set critical parameters to fulfill these requirements.

Commercializing products has become more challenging especially when launching complex drugs in a prefilled container and self injection device.

Component design and material selection during development must take into account the drug stability during storage, robustness of the container closure system and intended user requirements to ensure safety and effectiveness of the medicine.

In this talk, we will review component selection strategies being applied by leading companies for multiple drug delivery formats.

It is essential that components used to store and deliver drug products be of the highest quality and designed to support combination product needs.

Prefilled syringes are industry's choice of platform for further innovating your product and adding value.

With biological drug products being so complex, a huge amount of consideration needs to be taken regarding delivery method, design of primary packaging, device and analysis of product stability, safety and efficacy.

A system approach is needed because of the interaction between the biodrugs unique features (i.e. viscosity), drug delivery devices, such as autoinjectors, and syringes different geometries and elemental compositions.

All these are critical aspects that need to be carefully evaluated in order to guaranteed an effective, safe and painless injection to the patient.

This paper will highlight how to set critical parameters to fulfill these requirements.

Auto-injector devices are made up of complex and delicate components which require a well-orchestrated balance in order to perform properly.

Failures within auto-injector devices have lead to costly product recalls as well as delays in product commercializations.

Stalled device activations, long injection times, foreign particle contamination, and improper dosings are all symptoms of undetected problems during the production life cycle.

Many factors are required to be analyzed which may necessitate the use of advanced statistical and data mining tools in order to correctly identify the root of the problem.

This presentation outlines recommended methodologies for root cause investigations including required sample sizes, types of tests and their efficiency, and introduces new tools for use in statistical analysis.

As the race for biosimilars, new biologics and other self-injected drugs is on, many pharma companies build up portfolios of drug candidates many of them requiring a self-injection device for successful market launch.

This presentation provides an introduction into the field of self-injection devices and explains the main requirements and technologies for the different therapies.

The important device categories and features are presented and the interaction with the glass primary packaging will be explained.

Further the presentation gives an outlook on the trends for self-injection devices.

Equipment flexibility is one of the key challenges for the facilities of the future, which manufacture a new generation of pharmaceuticals with small volumes, a high degree of complexity and a high unit price.

The customer expects maximum flexibility from equipment manufacturers to consistently be in the position to react to new product and batch requirements in a timely manner.

Machine manufacturers need to act on such trends with sophisticated and flexible solutions. The central challenge when developing a multi use processing line is the handling of different containers such as ready-to-use syringes, vials and cartridges on a single machine.

A further challenge is the different stoppers, shapes and materials. OPTIMA pharma will present various stoppering methods and innovative engineered solutions integrated in a single multiuse filling machine and highlight the pros and cons of the different systems.

Following the trend to smaller batch sizes in the Pharmaceutical field a new kind of liquid filling equipment has emerged which addresses the need for high flexibility, short change-over times for reduced down time between batches, and the capability to process different kind of containers on the same filling machine.

The small scale filling systems can be used in conventional clean rooms as well as in isolators and they are optimized for the use of a disposable product path.

These machines in combination with single use kits and Ompi EZ-Fill nested syringes, vials, and cartridges, allow reduced time to market and short validation cycles.

RTP systems are now widely use in the pharmaceutical industry mainly on the final filling market. Those systems are principally used for the introduction of small sterile components (e.g., syringe stoppers) delivered in bulk into an aseptic filling line.

Even if these systems are compatibles with a large range of components needed during a filling process, these limitations exclude the major component for a filling line.

Our patented STERIPASS® system allow the use of RTP technology for the transfer of large components such as tubs/nests, trays, tools, large bulk components through an opening zone of 245mm(w)x175mm(h).

This presentation will introduce you this new RTP system Steripass®. We will present you technical features of our concept, the improvements vs the state of the art of this market, user benefits and an example of application via the EZ- Ecopack project.

Pharmaceutical manufacturers are faced with a competitive environment, while having to ensure patient safety through high-quality and absolutely reliable products. Also, they have to support healthcare providers who administer the pharmaceuticals. Last but not least, there is a growing trend towards patient self-injection.

When it comes to primary containers for injectables, customized labels with integrated functionalities can add value to the prod-uct by optimizing processes in healthcare practice and increasing drug safety as well as patient safety and user comfort.

In addition, sophisticated labeling solutions have to be eas-ily integrated into the pharmaceutical manufacturer’s dispensing processes.

Intelligent label designs for injectables are optimally tailored to the specific application and primary container.

New and unique approaches to adapt security technologies to primary packaging meet current anti-counterfeiting challenges. Costefficient and eco-friendly label-integrated safety devices for pre-filled syringes protect healthcare personnel from needlestick injuries. 

Lyophilization of parenteral drugs has gained application over the recent years. This preservation method extends the shelf life of products and prevents chemical interaction between aggressive product and glass.

With the increased demand for lyophilized products the interest for automated inspection of these products has gained more attention. 

The main challenge in automated inspection of lyophilized products is not detecting the defects, particulate matters or cracks in the glass wall, but rather avoiding false rejection of acceptable product variations to maintain a reasonable yield.

In this talk we will cover recent developments in detection of particulate matter.

More specifically, we will focus on new methods for detection of glass chucks, becausethese fragments are typically challenging to differentiate from a glossy/shiny cake surface. Finally, we will discuss the application of hyper spectral imaging to facilitate better separation between product and foreign materials.