Clinical Services | Primary & Secondary Packaging

Overview of clinical packaging & more on contract packagers offering primary & secondary packaging & labeling clinical services for drug products.

Q1. What is pharmaceutical clinical trial packaging?

Pharmaceutical packaging is defined as the collection of different components which surround a pharmaceutical product from the time of production until its use. Clinical packaging includes the packaging of clinical trial material (CTM). Unlike commercial pharmaceutical packaging, clinical trial packaging will never hit the shelves of retail stores. Clinical packaging is for research purposes only, so aesthetics take a slight backseat as compared to functionality and usability, which are of primary importance.

When it comes to packaging clinical trial material (CTM), one must use biocompatible primary packaging materials which are eligible for specific approvals and submissions. For example, oral solid investigational drug products such as tablets and capsules require primary packaging across different phases of clinical trials to be as efficient and compliant as possible.The complexities of clinical trial packaging services centre on the risks associated with numerous products being packed for different markets and clinical sites.

For effective clinical trial packaging, one should understand the global regulations, the inner workings of clinical trial protocols and fundamentals in ensuring the right packaging strategy is adopted for every pharmaceutical product. In this sector the primary considerations when designing primary and secondary packaging are functionality and usability since the pharmaceutical packaging materials are for research purposes and not for attracting consumers. The clinical trial packaging market for the clinical trials industry was valued at $44.3 billion in 2020 and is expected to reach $47 billion in 2021.

Deciding to embark on a clinical trial is a huge investment for pharmaceutical companies. It is sometimes beneficial to outsource clinical packaging pharma services to contract packagers. There are various contract packagers which have primary packaging capabilities and can offer clinical trial packaging services from small phase I studies that require a very limited number of packs, through to mega phase III clinical trials requiring an almost commercial-scale approach to packaging.

Contract packaging organizations for clinical trial material (CTM) are increasingly handling biologic drugs and parenteral drug products, which have more stringent packaging requirements than other drug forms. These organizations may offer extensive, global primary and secondary clinical trial packaging services, clinical supplies distribution and logistics, labeling, kit assembly and supply needs for clinical trials .

Furthermore, pharmaceutical contract packaging companies with secondary and primary packaging capabilities may provide a range of pharmaceutical packaging pharma services including primary and secondary packaging solutions as well as support services through the life cycle of drug products. Contract clinical pharmaceutical packaging service providers may also offer a range of innovative clinical packaging services including but not limited to primary and secondary clinical packaging services, clinical labelling, quality control, coding, serialization and aggregation.

Q2. What range of primary and secondary packaging solutions can one expect from clinical contract packagers?

As noted above, clinical trials are a huge investment for pharmaceutical companies. One way of strategically negating unexpected costs is to ensure that clinical supplies are prepared, packaged and shipped to clinical trial sites more efficiently. There are various contract packagers who can offer highly efficient clinical trial primary and secondary packaging services, clinical supplies distribution and logistics from small phase I to mega phase III trials, etc.

Clinical trial materials are packed for research purposes only, therefore drugs for clinical supplies escape the need for the same aesthetics associated with commercial packaging. Contract packaging organizations for clinical trial materials are increasingly handling all types of drug products including oral and parenteral-based drug products as well as biologic drugs. Contract packagers provide primary and secondary clinical packaging services and may also offer labeling & supply services and other primary and secondary packaging solutions for clinical trial supply management.

Some Clinical Primary and Secondary Packaging Solutions:

Clinical Primary Packaging Services

A primary packaging system is the material that first envelops a product and holds it. This material is in direct contact with drug products and can have an effect on the product’s shelf life. The main purpose of clinical primary packaging solutions is to protect and/or preserve, contain and inform the consumer about the drug product they contain.

Primary packaging services include bottling, multi-dose blistering, blistering with cold and thermoform capabilities, etc. Examples of primary packaging materials are ampoules, vials, blisters, bottles, sachets, strip packs, syringes, prefilled syringes, IV containers, etc. Primary packaging can be done in HDPE or glass bottles and blister packaging may be available in PVC/PVDC/Alu and Alu/Alu depending on requirements.

Clinical Secondary Packaging Services

A secondary packaging system goes outside the primary packaging and is used to group primary packages together. It provides the packaging that holds together the individual units of primary packaged goods, often grouping them into multipacked units. Secondary pharmaceutical packaging is thus not designed to hold the drug itself.

Typically, the level of packaging a consumer will see first is the secondary pharmaceutical contract packaging which makes the appearance of secondary packages very important. Secondary packaging services involve labelling, artwork design, translation services, randomization, label printing, patient kit assembly, cartons, boxes, shipping containers, injection trays, etc.

Contract packagers that have primary packaging capabilities along with secondary packaging capabilities may provide clinical trial packaging materials such as wallets, cards or child resistant boxes for oral and parenteral-based drug products. The desired clinical packaging solutions can be designed according to the protocols of a clinical trial project.

Q3. What are the considerations for clinical trial labeling and packaging in the industry?

Labeling is very important in pharmaceutical packaging. Clinical labeling is a crucial part of packaging clinical trial materials (CTM). Labels for clinical trial packaging require the same degree of batch-to-batch consistency demanded from raw materials. Designers of pharmaceutical clinical packaging solutions must collaborate with regulatory personnel and engineers on their team to gather a list of symbols and text necessary for all labeling.

As the demand for drug development increases, pressures will continue to mount. Without the right clinical trial labeling and packaging materials, one could risk the success of a clinical trial. Lack of consistency in labeling also carries the risk of biases that could inadvertently affect the trial. Therefore, following certain considerations for primary and secondary clinical packaging services like labeling can be beneficial.

Considerations for Clinical Trial Labeling:

- Cold-chain and Pharmaceutical Packaging Integrity

For biologic drug products, cold-chain storage and transportation are crucial parts of the pharmaceutical packaging design. Although indicators could warn a patient of potential damage to a product, the aim of pharmaceutical cold chain solutions is to maintain the supply chain so that a package arrives without any damage.

- Serialization of Labeling for Clinical Trial Material (CTM)

The FDA requires serialization of labeling for clinical trial materials. The most important consideration for serialization is protecting dose anonymity in a blinded or double-blinded clinical trial.

- Blinding of Clinical Trial Material (CTM)

Customers typically receive clinical trial drugs from suppliers with the packaging often being ‘blinded’ by alterations or redesigns to ensure that patients can’t spot any differences. This is an important factor to consider in clinical trials to compare the effectiveness of two different drugs without any biases.

- Selection of Adhesive Materials

Choosing the right label format for a clinical trial is just one piece of the puzzle. One also needs to select the best adhesive material using appropriate clinical trial labeling and supply services.

- Tamper-evident Labels

Tamper-evident labeling and packaging also plays a major role in clinical packaging. It’s imperative that the clinical trial team of any organization ensures that clinical labeling and clinical packaging aligns with all regulations and industry standards while facilitating the best possible patient outcomes.

- Late-stage Customization

It is vital to keep late-stage customization strategies in mind when designing patient kits and labeling during clinical trials.

- Clinical Trial Study Size

The size of a clinical trial (i.e. the number of patients along with the necessary dosing) determines the required supply of clinical trial material (CTM) and other pharmaceutical products. To accommodate a clinical trial’s needs, its enrollment rate should be considered.

Contract pharmaceutical packaging organizations have the ability to handle phase I to phase III projects. They can offer a wide range of clinical packaging services and clinical trial packaging and labelling services with high levels of accuracy, meticulous inspection and QC oversight.

Clinical trial packaging and labelling pharma services include label design, printing, and application, patient kit assembly, blister packaging, carding, small lot bottling, high-speed bottling, etc. Contract packagers may also offer options such as traditional clinical packaging and labelling services as well as on-demand and direct-to-patient packaging services.

Q4. Which are the leading pharmaceutical companies offering clinical packaging services?

Various contract packagers, CMOs and CDMOs which have primary and secondary packaging capabilities may offer clinical packaging services, labeling & supply services, clinical supplies distribution and logistics, bottle filling and blister packaging services for the pharmaceutical and biotechnology industry. From design through distribution, contract packagers may offer a full range of cost-effective clinical primary packaging solutions along with secondary packaging services to protect materials across the entire pharmaceutical supply chain.

Pharmaceutical contract packagers may provide clinical packaging solutions for oral and parenteral-based drug products amongst various other formulations. They can meet one’s needs for clinical packaging services along with commercial primary and secondary packaging solutions. The leading companies offering pharmaceutical clinical packaging services are noted below:

Sharp - Pharmaceutical Packaging Services for Clinical Trials

Sharp serves pharma and biotech clients by offering clinical trial services including clinical primary packaging solutions, clinical manufacturing and formulation development, etc.

Catalent - Clinical Packaging and Labelling Services

Catalent offers labeling assistance for clinical trial material (CTM) and regulatory label review for US, EU, Israel, Eastern Europe and Russia, Canada, Australia and New Zealand, Asia Pacific and Latin America.

Eurofins CDMO - Primary Packaging Solutions

Eurofins CDMO can provide clinical packaging services and commercial primary packaging services for non-sterile solid forms (capsules, tablets) in HDPE bottles or blistering in class C rooms. They provide bottle filling from 15 to 600mL with several options for caps.

Neuraxpharm - Bottle Filling Solutions

Neuraxpharm offers the development, manufacture and control of generic pharmaceutical specialties, both for Neuraxpharm and other laboratories, performed at its Lesvi facilities in Sant Joan Despí, Barcelona, Spain.

Mikart - Clinical Packaging Services

Mikart has primary and secondary packaging capabilities and offers cartoning and tray packaging for physician samples, RX and OTC trade packages and clinical trial material (CTM). They offer labeling & supply services, clinical services and can package bottles, blisters and pouches into a wide range of carton and tray sizes.

Fisher Clinical Services - Clinical Packaging Services

Fisher Clinical Services runs the world’s largest clinical packaging operation. Whether your trial is a small phase I or a multinational global phase III trial, Fisher Clinical Services offers clinical packaging and labelling services through their primary and secondary clinical packaging capabilities.

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Quotient Sciences supports drug product supply for phase III clinical studies and commercial supply. It offers clinical and commercial packaging of blisters, bottles and tubes.

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Mikart offers cartoning and tray pharmaceutical packaging for physician samples, RX & OTC trade packages and clinical trial material (CTM). It can package bottles, blisters and pouches into a wide range of carton and tray sizes to meet your needs.

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Douglas CDMO develops, manufactures, and packs various dosage forms, and provides regulatory support for international distribution.

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Douglas CDMO has a dedicated team of experts specializing in both clinical and commercial packaging. Its clinical trial packaging capabilities include blistering, bottling, liquid, suppositories, and ovule filing.

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Renejix leverages its world-class secondary and primary packaging services for clinical to commercial scale products. Its secondary clinical packaging & labeling services include automated wallet sealing, patient kit design, cold room packaging, etc.

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Biopharma Group

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