Streamlining Key Services your Drug Delivery Device Partner Provides
pharmafile | October 24, 2012 | Feature | Manufacturing and Production | auto injector, autoinjector, final assembly, pen injector, shl group, shl pharma
Extensive project management expertise and logistical control know-how are obviously required when working on a combination product from the concept stage to eventual launch. Cross-functional teams from both the biopharmaceutical company and device supplier must work together for several years to coordinate efforts in a collaborative manner, overcome related challenges and ensure the right steps are taken. Taking into account the number of biologics coming to market and the entry of biosimilars, we see an increasing number of biopharmaceutical companies in need of the same services currently provided across various geographic areas by a broad number of suppliers and specialists.
Over the years, a few early-mover biopharmaceutical companies gained valuable experience producing their own devices, working with the suppliers of devices and by establishing a good rapport with companies providing related services. These early-movers have experienced first-hand the extensive number of pieces within the combination product puzzle that need to be put together to move forward with a device such as an auto-injector.
Some of the choices that need to be made by the biopharmaceutical company include selecting a suitable primary container, filling supplier, regulatory consultants, human factors engineering [HFE] experts, final assembly integrators, and so on – all vital to the successful launch of your device. And the benefits of bringing an innovative device to market clearly make the investments of time, finances, and resources, worthwhile for biopharmaceutical companies.
Of all the choices that need to be made, selecting the right drug delivery device partner should be considered one of the highest priorities. And to support that selection process, visiting potential drug delivery device suppliers, looking at their track record and understanding their company culture are obvious, but it may also be helpful to focus on the following 3 areas:
DEVELOPMENT
Taking a product, such as an auto-injector, from early design and moving it towards being ready for mass production is a complex process. Development involves several stages such as Planning, Design, Engineering and Process Validation. As a project moves forward, having both the design and development teams in the same company is ideal, but not always possible. For example, the mechanical or technical design of the device may come from the device company, but the biopharmaceutical partner may choose to utilize an external industrial design company for appearance of the device. Involving another party may certainly add a new flavor to the uniqueness of the product, but doing so may also slow down the overall development of the device by simply adding to the growing number of voices involved in your project. At the end of the day, there are pros and cons to both approaches.
During the development process a delicate balance exists between providing device design features that fulfill end-user needs and making certain that device design is manufacturable. It is between these two areas that one has to find equilibrium; if they come into conflict with each other, the end-user needs should always have priority over the manufacturing process, so long as it does not affect the safety and effectiveness of the device. Finding a balance is the key. SHL, for example, works closely with customers to develop devices that complement the manufacturing process.
During the development stage we ‘cut steel’ and start to verify the design of the device by performing extensive physical tests such as proving the mechanical sequence of the prototype devices. We review numerous SLA models and other prototypes of device variations for the industrial design and work with patient groups to find a shape for our devices that patients like, but also a shape that can be produced and assembled efficiently. Over the course of the development process we ensure that the design of the device is robust and the functionality is there.
Several factors involved in the development process rely heavily on consistent and effective communication between all parties involved in the project. This is one of the reasons why SHL has chosen to pursue the strategy of maintaining all key capabilities, processes and services needed to develop and produce drug delivery devices in-house. By doing so we enhance speed-to-market and help drive projects forward, especially during the development of any device.
However, it is important to recognize that not all things can or should be brought in-house. At times there is a need to involve experts or consultants for guidance in areas such as: human factors engineering, packaging materials, freedom to operate (FTO) opinions and so on.
CAPABILITIES
Manufacturing advanced drug delivery devices requires an extensive range of capabilities. Tooling, molding, automation, assembly, and metrology are just a few of the many capabilities which are utilized. While maintaining such capabilities in-house is ideal, in some cases, it is just not practical due to the extensive capital investment that a drug delivery device supplier is required to make. In addition to purchasing and maintaining the required machinery, developing the expertise needed to run this equipment at an optimum level is challenging and takes time. For these reasons, some drug delivery device companies, such as SHL, have followed a staged approach to incorporate key manufacturing capabilities ‘in-house’ over several years and many suppliers have been forced to accelerate this expansion in recent years due to an increase in orders and a desire to maintain a sufficient level of capacity.
Tooling and automation are two areas that deserve special attention by biopharmaceutical companies as these capabilities are sometimes outsourced by device suppliers. Tooling is a significant expense in any drug delivery device program and lead times must be planned for carefully. For high volume projects multiple sets of tooling are needed for production, safety stock and risk mitigation. The intellectual property of new devices must be protected by strictly controlling who has access to these tools and related drawings. Taking tooling in-house is very costly for device suppliers, but can really help control quality and timeline concerns. In addition, having a capability like automation internally means that a device company can quickly build robust and flexible solutions for assembling and testing devices even while the design for the device is still being finalized. Certain tasks can be done in parallel and this will increase response times.
Metrology is another area that is vital to having a successful device project. For example, the dimensional precision of components is critical to ensuring a device can be properly assembled and that it functions as intended. Some devices have as few as 3 components, while others have more than 45. Metrology study for drug delivery devices is a specialized skill and related training is paramount as it takes years to develop a certain expertise in this field. For high volume projects where greater metrology utilization is needed, biopharmaceutical companies should ensure that their suppliers have enough of the right equipment, adequate numbers of well-trained staff and the resources to avoid potential bottle necks in this area.
Spring production may be one of the last capabilities that people would think of ever in-sourcing, but in many ways the spring is the primary driver to successful injections performed by most auto-injectors. Some devices have 3 springs, each with their own unique requirements and some very specialized. If springs are too powerful they can cause breakage, if not powerful enough injections can stall. Certain springs are ideal for dealing with highly viscous biologics, others are more suited to ensuring that a more consistent force is achieved and that completeness of injection is not an issue because no one focused enough attention on this component. In addition to springs, there are several other metal components crucial to the functionality of a high-end drug delivery device. Ideally, these metal parts should be produced in-house in order to maintain optimum control and quality.
FINAL ASSEMBLY
Once the sub-assemblies of a device are produced the next step is integrating them with the biologic-filled primary container to create a completed combination product. Biopharmaceutical companies basically have three options to consider at this stage: do final assembly themselves, outsource to a third-party, or find a drug delivery device partner that can provide this service.
In response to customer requests to provide final assembly of combination products, many device suppliers, including SHL, offer final assembly, labeling and packaging services for devices to pharmaceutical and biotechnology companies. In the case of SHL, a specialized company was established as SHL Pharma, streamlining the production and distribution process for SHL Medical products, improving end-product quality and speed-to-market for customers. By integrating an additional piece of the supply chain, SHL can now offer a full one-stop-shop experience, from product design to distribution. Utilizing our in-house automation expertise to produce customized assembly and test equipment is a significant advantage that helped SHL when setting up SHL Pharma operations in Florida, USA.
From a quality and regulatory point-of-view, final assembly facilities should be ISO13485 certified and registered with FDA as a drug establishment, qualified to handle and distribute pharmaceutical products. Additionally, they should conform to all other regulatory requirements for medical device and pharmaceutical packaging and distribution, as per 21 CFR Parts 820, 210 and 211. The staff involved at this level will have both drug and device expertise to help ensure the safe production of the combination product.
In addition, when a project will soon enter the final assembly stage there are a number of new considerations that also must be addressed , such as types of packaging, labeling, Instructions For Use [IFUs], inserts and more. Protective packaging not only holds the device for shipping, it helps to protect it if designed properly. Clear IFUs will also help to ensure that end-users know how to use your combination product properly. Drug delivery device suppliers should independently, or in cooperation with external experts, be relied upon for guidance in these areas.
INSPIRING INTEGRATION & THE WAY FORWARD
Enhancing the convenience and ease of administering biologics is a proven strategy for biopharmaceutical companies to augment product differentiation and to compete in an increasingly competitive market. As patients become more familiar with various types of drug delivery devices they will expect suppliers of these devices to continue to innovate and to take their true user needs into consideration. Biopharmaceutical companies that proactively partner with experienced drug delivery device suppliers will be able to ensure that such needs are met and that projects can be completed on time.
The term “inspiring integration” is used internally at SHL to remind our staff of the importance of continually improving, and strengthening the in-house capabilities and services that we can provide to our biopharmaceutical partners. Controlling the number of companies, suppliers and individuals involved in the design, development, production and final assembly of your combination product will result in improved communication, enhanced time to market and stronger control of the supply chain.
Related Content
Novartis secures US rights to Adamis’ epinephrine auto injector
Novartis has penned an agreement with Adamis Pharmaceuticals to commercialise and distribute the latter’s epinephrine …
FDA unveils guidelines to help generic medical device versions reach the market
The scandal surrounding Mylan’s price-hiking of its flagship EpiPen epinephrine auto-injector was the news of …
SHL brings innovation to Pharmapack Europe 2017
As a forward-looking company with extensive knowledge and experience, SHL delivers solutions for today on …
