Contract packaging supports pharmaceutical innovation

NASDAQ’s Globe Newswire reported the predicted global growth for the contract packaging sector in April 2017. In the same article, it also explained that updated international regulations that were being introduced required all packaging of pharmaceuticals to be conducted in Class X clean rooms.

This and other regulatory changes like serialisation are driving manufacturers to outsource packaging to contractors that have the relevant infrastructure and expertise to ensure compliance.

In addition, innovation in the types of medication being brought to market is facilitating packaging innovation at a rate and scale that requires costly changes to packaging lines. If drug manufacturers had to overhaul internal production lines on such a scale it would dramatically lengthen time to market, not to mention making the cost of bringing the drug to market utterly unfeasible.

By outsourcing to a specialist pharmaceutical contract packaging firm, manufacturers have access to expert support in meeting regulatory requirements and can bring their latest medical innovations to market more cost effectively.

The challenge of serialisation

The threat posed by counterfeit medication has challenged the industry for years, and regulation to protect people from black market medicines has had to advance to remain effective.

This is what drove the European Commission (EC) to start work to amend Directive 2001/83/EC to address these concerns under the Falsified Medicines Directive (FMD) in 2011.

The updated FMD, the final phase of which will come into effect in February 2019, aims to protect patients by reducing the chance of counterfeit drugs entering an established supply chain. It will introduce a system to track and record legitimate medicines as they traverse from manufacturer to patient.

Under the new directive, manufacturers will have to add safety features to every pack of medication, including a tamper-proof security seal and a barcode. The barcode will allow each pack to be serialised with an individual, random number that will be authenticated before shipping.

This identifying data is going to be stored in a database managed by the European Medicines Verification Organisation (EMVO) and supported nationally by the UK Medicines Verification Organisation (UKMVO).

While this tightened regulation is great for patient safety, it poses interesting challenges to pharmaceutical manufacturers. Not only is there an additional phase to add to the packaging process, which will necessitate changes to production lines, labour and machinery, there is also a dramatically increased data management burden.

Businesses will need to invest in upgrading IT functionality to meet the data capture and sharing requirements of FMD. While this would be a massive capital investment for a manufacturer, if they outsource packaging to a specialised contractor already set up with local and cloud networks to support data transfer they are spared this financial hit.

Staying ahead of the curve

Regulatory compliance alone seems reason enough to be driving growth of contract packaging. However, there are other benefits to manufactures choosing the right contract packer.

An article by Doug Bartholomew on Pharmaceutical Manufacturing in September 2017 states that, “contract packagers are providing much of the innovation in how many new drugs … are brought to market”.

In recent years, medical technology has made some amazing advances. We have seen the development of several new drug delivery methods that are of great benefit to patients, such as auto-administered biologicals and oral thin-film dissolvable medication.

Each of these new types of drug has new packaging, labelling, storage and shipping demands. Contract packaging specialists that make sure they are cognisant of the latest drug technology developments will be able to adapt their systems, processes and production lines to easily accommodate the corresponding innovation in packaging.

For example, many of these new medications rely heavily on packaging that separates required doses or equipment for different steps the patient must follow to take them safely. Additionally, this type of medication is heavily reliant on cold-chain storage and distribution.

As well as new drugs, contract packagers must also be aware of any new trends being driven by pharmacies or end users. For example, the industry is currently experiencing a shift away from large count bottles for tablets and capsules. Instead, the preference is for smaller bottles or personalised medication.

Keep it simple

The pharmaceutical contract packaging sector is truly set to come into its own in the next few years. If businesses in this sector can prove the value on offer to pharmaceutical manufacturers they will free up the sector to invest more funds into drug research and development and drastically reduce the time to market.

However, there are a lot of plates for a packaging contractor to keep spinning to achieve this. Where possible, they need to keep things simple and hassle free. One easy way to do this is to choose suppliers that work with them in a straightforward way.

At Valley Northern, for example, we provide contract packers with materials from bottles, cartons and labels through to the necessary measuring tools, gloves and disposable overshoes to keep everything running. Our straightforward, online customer portals support easy reorders and send automated updates wherever they are needed.

With production often running 24 hours a day in packaging facilities, you need to know there is a reliable service to make sure you never run out of valuable supplies. We even make sure to offer our customers additional warehouse storage, so they can order cartons in bulk and simply request delivery of more whenever they need them — saving space onsite.

It’s a complicated business, but there is no doubt that the pharmaceutical industry is going to become heavily reliant on outsourced packaging. Packaging firms that adapt to stay ahead of changes in the regulatory and technology landscapes will be vital in the advancement of modern medicine by solving challenges that distract drug companies from development of new treatments.