Complete combination product team in place with new associate
The development of combination products is speeding up, and many pharmaceutical companies view the “diagnostic or therapeutic products that combine drugs, devices, and/or biological products” (as defined by FDA) as a key part of their new product pipeline.
In many cases, firms are dusting off their older drugs and generating new intellectual property around a new delivery technology.
The most common types of combination products are pulmonary inhalers (eg, dry powders or pressurized aerosols), injection systems (e.g. pen injectors and auto-injectors), and infusion systems (e.g. ambulatory syringe pumps delivering continuous subcutaneous drug delivery).
Other types include nasal sprays, creams, eye drops, and ear drops.
There are many reasons behind the rapid development of combination products.
For the pharma companies is it most probably related to the rise of biosimilars as well as the need for differentiation, and maintaining interesting products despite long product lifecycles. But also the shift towards increased decentralization of patient treatment, convenience and patient administration are all important factors contributing to increasing focus on combination products.
The consequence of this is that the two sister-industries, medical device and the pharma industries, to some extent are converging – and they require dedicated focus and knowledge of R&D, RA and QA issues in relation to combination products.
Combination products require combined expertise
At Medicologic it is clear that the shift towards combination products not only implies converging functionality but also convergence of knowledge and regulations. “Actually what we are experiencing is that combination products are putting a lot of pressure on the people involved in developing these new devices”, says Michael Funder, CEO. The reason behind this is related to regulatory/QA requirements as well as the complex engineering aspects of combining a device and a drug.
First of all, there are very different regulations in place that need to be interpreted. Secondly, these regulations are undergoing dramatic changes that need to be closely monitored. Often, the difference between regulatory requirements for devices and drugs is underestimated by the people involved.
And finally, the R&D work involved is rather complex. It can be difficult to bridge the expertise needed for creating the required drug delivery performance in a certain medical device. Michael Funder mentions dosing mechanisms as an example of a crucial part of the success for a new combination device, which can be quite tricky – and some pharma companies tend to underestimate this.
New resources in Medicologic
That is also why Medicologic has decided to upgrade on combination product engineering resources.
Jacques Jonsman, PhD, a skilled combination product developer with many years of experience for leading med-tech and pharma companies, is now an associate of Medicologic and clients can now expect a strong team ready to work on of combination product challenges.
Jacques brings a number of important competencies to Medicologic. In particular he has experience with:
[divider margintop=”1″]Knowledge and testing is crucial for success According to Jacques, if you don’t have the experience with combination devices – you are bound to fail the first time or make major mistakes that inevitably will result in longer time to market. “Many people think you just add a drug to a device, but it is more complicated”, says Jacques. According to Jacques Jonsman the truth is that regardless of whether you are coming from the device or pharma side, you are going to meet completely new challenges.
Combination products should be a strategic consideration
When speaking with key industry players, it is clear that we are only at the beginning of a business trend. This is something which is high on the strategic agenda for Medicologic and according to Michael Funder, CEO at Medicologic, it should also interest not only engineers, regulatory and quality personnel – but should be high on the management agenda. “We believe this is a strategic choice and should be part of the future planning for most senior management people in medical device and pharma companies”, he says.
According to Michael Funder, the next years will see more standardization and consolidation when it comes to drug delivery standards for OEMs. “This will become a huge part of the industry in its own – and that is why we now have strong resources in place for R&D, RA and QA to support our clients across different kinds of devices. We have a really positive outlook for the future and with the capabilities in place we welcome any challenge our clients might have”, he finishes.
Examples of challenges in developing combination products *
Container Closure System
Devices are often considered a part of or the entirety of a container closure system (CCS). Per FDA Guidance for Industry-Container Closure Systems for Packaging Human Drugs and Biologics, “A container closure system refers to the sum of packaging components that together contain and protect the dosage form.
This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product.” This critical distinction is important as the vials, ampules, bottles, or molded components a company uses to house a drug must be tested with the drug and be considered a “whole” throughout the product development process.
Drug product integrity and effectiveness are additional aspects for why CCSs need to be thoroughly tested against edge-of-failure conditions. Any potential breach of a CCS for a sterile product, parenteral, or injectable could introduce byproducts, toxins, impurities, or other foreign materials that could impact the drug product stability profile; the drug product could be less effective for the targeted disease state, adverse reactions could manifest due to the foreign materials or degraded product, or a combination of these two could happen. The CCS must allow for the product’s integrity throughout the supply chain until the end of expiration.
The device can have a significant impact on product performance. First, the device is the primary user interface, controlling the user portion of how the drug is delivered. Human factors engineering and industrial design should influence this portion of device development. The device is the means by which the drug is pressed, extruded, inhaled, or otherwise “delivered” to the patient. Requirements that establish the position of the drug – prior to delivery, the delivery path, the method of delivery activation – all impact how much (volume) and at what rate (time) the drug enters the patient.
The drug formulation may impact how the drug moves, interacts with, and is delivered through the device. Some formulations may be sensitive to molecular shearing and require slow, laminar delivery through the device, while other formulations (especially inhalers) may have high static charges that attract to plastic, requiring device materials that dissipate static electricity.
Additionally, some formulations need to be developed with the intent of the device and sterilization method in mind. Some substances, especially peptides, are extremely heat labile, where protein molecules can break apart, degrade, or get altered into a new form with high impurity profiles that can become toxic if administered.
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