By PharmaCompass
2023-06-07
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View Sharp's clinical trial supply & contract pharmaceutical packaging services, including blisters, bottles, sachets, pouches & PFS on PharmaCompass.
What is Sharp and what services does it offer?
Sharp is a global leader in clinical trial supply chain services and contract pharmaceutical packaging, with a history dating back more than 70 years. Sharp provides solutions and support starting from phase I clinical trials and continuing through commercial launch and lifecycle management.
Its network of GMP facilities provides worldwide reach, production scalability, and risk mitigation by validating several identical lines across its network. Sharp comprises two dynamic international divisions, Sharp packaging solutions, and Sharp clinical services. Its 1,600-strong team works from state-of-the-art facilities in the US, the UK, Belgium and the Netherlands.
Sharp provides pharmaceutical formulation development, contract manufacturing, comparator sourcing, primary and secondary packaging with labeling, storage and distribution services as part of its clinical trial supply services. It also offers direct-to-patient solutions, clinical trial technology solutions (Clinteract and Clinventory) with project management as well as gene therapy clinical trial services.
As part of its commercial packaging services, Sharp provides blister and bottle for primary and secondary packaging, oral thin film and transdermal patches along with pouches and sachets (primary and secondary), kitting and gene therapy commercial packaging services. It also offers packaging design services, serialization and aggregation along with project management and commercial packaging.
Along with contract packaging of oral solid dosage forms, Sharp offers packaging services for injectables, such as vial, autoinjector, pen assembly, pre-filled syringe (PFS) assembly, labeling and packaging with small-scale sterile fill-finish capabilities.
Sharp supports integrated clinical trial supply services and commercial packaging services with a broad range of capabilities and deep expertise. It provides both shared production lines and dedicated technologies with suites as per the needs of the customer.
What are some of Sharp's clinical manufacturing services?
Sharp's clinical services division is the world leader in providing innovative clinical supply chain services, with a highly experienced team that can handle all aspects of the client's supply chain.
Sharp assists clients in navigating their journey to market by lowering the risk, time, and complexity of their clinical trials. Its responsibilities include everything from product development and production to clinical supplies packaging, labeling, distribution, qualified person audits, and comparator sourcing. Sharp provides various clinical trial services, which are listed below:
Pharmaceutical Product Development: Sharp assists clients in navigating their formulation development challenges and commercialization problems. It also offers product development services for a wide range of oral solid dosage forms, including immediate, modified, delayed, extended-release, controlled-release tablets and capsules, as well as orally disintegrating tablets (ODTs).
It offers clinical manufacturing of various dosage forms that contain highly-potent compounds, DEA controlled substances (schedule I-V), a combination of multiple APIs and placebos (solid, semi-solid, and liquid dosage forms). It also allows over-encapsulation for double-blind tests with enhanced bioavailability.
Contract Manufacturing: Sharp provides customized clinical manufacturing solutions and a broad range of contract development and manufacturing capabilities for complex dosage forms such as modified release tablets and capsules, including mini tablets, fixed-dose combination products, and powder in sachets.
Sharp ensures the integrity of clients' double-blind studies by designing, developing and manufacturing placebos and trial doses that correspond to the client's drugs and existing comparators, supporting development services and reformulations in phases I-IV. It also provides clinical manufacturing for liquids and semi-solids such as true solutions, nasal sprays, powders for reconstitution or suspensions and gels.
Sharp, in collaboration with innovative sterile manufacturer Berkshire Sterile Manufacturing (BSM), provides clinical scale isolator-based sterile filling of syringes, vials, and cartridges. The use of isolator-based filling technology eliminates the risk of human contamination throughout the formulation and filling processes. Sharp also offers global comparator sourcing, procurement, and blinding to ensure the scientific credibility of clinical trials.
Comparator Sourcing: Sharp not only sources reliable materials, but also delivers integrated services such as packaging and labeling, as well as over-encapsulation of oral solid dosage forms and the production of placebo capsules for study blinding.
Primary Packaging: Sharp is a reliable clinical packaging partner. It provides isolator-based sterile fill-finish, a wide range of primary clinical packaging services, and complementary clinical supply chain capabilities. Sharp is also a cold-chain specialist, handling products at -70°C and conducting secondary packaging and labeling at 2-8°C and -20°C.
Labeling and Secondary Packaging: Sharp provides a comprehensive range of rapid and scalable labeling and secondary packaging services across all formats, spanning the whole lifecycle of a client's investigational medicinal product (IMP).
Sharp also supports cold-chain labeling and packaging from 2-8°C to -70°C. It has a design and logistics team to assist clients in addressing the challenges of blinding the products that are ready for trial. Sharp's clinical labeling expertise can help customers efficiently package clinical trial IMP for patients from any region. It designs and prints multi-language clinical labels for customers all around the world.
Storage and Distribution: Sharp provides customized and regulatory guidance on the storage, distribution and on-time delivery of clinical trial materials around the globe. Sharp has strong cold-chain capabilities, including ambient, chilled, and ultra-low frozen storage and distribution, as well as approved temperature monitoring devices.
Direct-to-Patient Solutions: Sharp provides global distribution services and is ready to meet clients' requirements for direct-to-patient clinical supplies. A decentralized clinical trial approach brings specific considerations for optimizing the clients' distribution chain for direct-to-patient clinical trials.
Clinical Trial Technology Solutions: Sharp has created a suite of clinical trial solutions to help clients manage their trials more effectively. Sharp has expertise in successfully managing patient interactions and drug supply during clinical trials, thanks to its considerable experience in providing clinical IRT (Interactive Response Technology) services.
Sharp is designed to successfully handle patient interactions and drug supplies for clinical trials. Clinventory offers all the benefits of the IRT's clinical trial supply chain management, but without the additional costs of subject randomization and management.
Gene Therapy Clinical Trial Services: Sharp collaborates with clients to bring their gene therapies efficiently and safely through clinical trials. Based on its experience and capabilities in small-scale supply and clinical trial supply services, Sharp is ideally positioned to support clients with dedicated solutions for their gene therapy trials.
What range of contract commercial packaging solutions does Sharp offer?
Engineered to deliver on time, in full, and to the highest quality, Sharp has established itself as a reliable partner for pharmaceutical and biotech packaging. Sharp has an exceptional global reputation for designing, serializing and manufacturing innovative, cost-effective compliance packaging for even the most complex products.
Sharp's list of extensive services comprises blister packs, bottles, pouches, and stick packs, but its expertise extends far beyond every stage of contract development and manufacturing to design and delivery. Its mission is to provide unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industries.
The various commercial packaging services offered by Sharp are listed below:
Bottles (Primary and Secondary): Sharp specializes in pharmaceutical oral solid dosage form bottling and packaging services, offering extensive expertise and flexibility to ensure product stability. With its state-of-the-art facilities and advanced equipment, Sharp can handle a wide range of bottle and solid oral dose shapes and sizes. Its precise equipment, coupled with in-line fill sensors and check weighers, guarantees accurate fill count for the packaged drug products. By providing comprehensive packaging solutions, Sharp ensures that pharmaceutical products are packaged efficiently and maintain their quality throughout the process.
Its bottle packaging services include component sourcing, carton printing and in-line cartoning or bundling, extensive onsite engineering and validation support, serialization and aggregation, and strict quality control to ensure that clients' drugs are packaged to the highest standards.
Blisters (Primary and Secondary): For over 65 years, Sharp has been a leader in the blister packaging of pharmaceutical oral solid dosage forms. Sharp is a market leader in pharmaceutical oral solid dose blistering due to its extensive expertise, understanding of global regulatory and compliance challenges, and comprehensive capabilities.
Sharp assists clients in choosing the best blister pack format, material and methods based on their drug specifications. The packaging design team at Sharp uses cutting-edge software and technology to provide extensive services, ensuring the clients' drug packaging is both patient-friendly and visually appealing in the market.
Engineering Services: The engineers at Sharp are dedicated to continuous innovation and exploring new approaches that bring value, improve operational efficiencies and reduce risk. Whether a client chooses to leverage Sharp's labeling and packaging line equipment or require a custom-designed packaging line, its engineers offer expert guidance and recommendations for both common and challenging packaging requirements.
Injectable Packaging: Sharp provides customized packaging services specifically designed for injectable products, catering to both small and large-volume batch sizes. With a focus on flexibility, Sharp can deliver swift launches across multiple countries from its injectable centers of excellence in the US and EU.
Sharp specializes in cold chain storage, temperature and light-controlled packaging, serialization, and specialty distribution. It offers comprehensive contract pharmaceutical packaging services for a wide range of injectable devices, including vial labeling, autoinjector and pen assembly, labeling and packaging for pre-filled syringe (PFS), cartoning and kitting as well as small-scale sterile fill finish.
Sharp also provides packaging design services for injectable products. Its global design team works in collaboration with clients to understand their product specifications and propose the most suitable solutions for vial, pre-filled syringe (PFS), and autoinjector packaging for drug launches and sampling programs.
Sharp offers a wide range of solutions for autoinjector or pen devices, available at its packaging facilities in the US and EU. Sharp has the capability to design and run a dedicated line for autoinjector or pen devices. It can also handle the labeling and packaging requirements for various pre-assembled autoinjector and pen devices currently available in the market.
Sharp enhances its core packaging services by offering essential capabilities for biotech drugs. These include packaging design, cold chain storage, packaging in temperature and light-controlled environments, serialization and specialty distribution.
Sharp offers scalable vial labeling and packaging services through its team of experts and best-in-class packaging systems. Sharp is an industry leader in assembly, labeling, and packaging and has extensive experience delivering pharmaceutical and biotech pre-filled syringe (PFS) packaging solutions from its facilities in the US and EU.
By leveraging its technical expertise and unique capabilities, Sharp can accelerate the market introduction of client's injectable formulations. Through its partnership with Berkshire Sterile Manufacturing (BSM), Sharp offers a seamless and comprehensive range of high-quality, end-to-end clinical manufacturing, contract manufacturing, packaging, and distribution solutions for injectables. BSM is a specialized contract manufacturer that utilizes a unique 100% isolator-based sterile fill-finish system in its production lines, delivering complete sterile assurance and unparalleled quality in formulation development and filling processes.
Serialization and Aggregation: Sharp is an industry leader in serialization. Its serialization and aggregation services guarantee adherence to stringent global regulations designed to improve the security of the drug supply chain and safeguard patients.
Kitting: Sharp offers a comprehensive range of customized kitting solutions for biotechnology, pharmaceuticals, and medical devices industries. These solutions are designed to efficiently package multiple components into a single, self-contained package.
Design Services: Sharp's team of design engineers, structural engineers, and graphic designers, with their knowledge of regulatory and supply chain challenges, position the company as a market leader in the design and delivery of secondary pharmaceutical packaging.
With years of experience in developing innovative packaging, Sharp's designers provide expertise in brand development, existing artwork modification, FDA submission requirements, marketing studies, 3D rendering (3D printing), child resistant/senior friendly compliant packaging design, packaging samples, tray design, and shipper and pallet design.
Oral Thin Film and Transdermal Patches (Primary and Secondary): Sharp specializes in the primary and secondary packaging of oral thin films and transdermal patches. It offers specialized packaging services through quality processes, and has extensive expertise in die-cutting and pouching sublingual and oral dissolvable films, as well as transdermal drug delivery systems.
With decades of experience in contract pharmaceutical packaging, Sharp possesses comprehensive capabilities and is supported by quality operations and project management expertise. This enables Sharp to provide the best packaging solution to protect specialty drug format.
Pouches and Sachets (Primary and Secondary): Sharp provides expertise in pouch and sachet filling for a wide range of products, including solid dose, powder, thin film, and transdermal patch formulations. With a robust assembly of form, fill and seal technology, Sharp offers extensive capabilities in pouch/sachet packaging, supported by its commitment to quality operations and project management expertise. By utilizing its precision-engineered technology, Sharp offers various sealing techniques for 4-sided pouches, weight verification as well as labeling and printing directly onto sachet material.
Gene Therapy Commercial Packaging: As a leading commercial packaging provider with 70 years of experience handling complex pharmaceutical packaging requirements, Sharp is well-equipped to deliver specialized services tailored to meet the requirements of its clients. It offers the best blend of both clinical and commercial expertise, ensuring that gene therapies reach patients who need them. Gene therapies, unlike traditional therapies, follow patient-led 'demand chains' that require a whole new approach to supply chain support.
What is the difference between primary and secondary packaging? How does Sharp handle the complexity of pharmaceutical packaging?
Effective packaging plays a vital role in the pharmaceutical industry. It ensures the protection of the drugs during storage, sale, shipping, and use. The packaging of pharmaceutical products also depends on the type of drugs, considering potential reactions between the drug and its packaging. The packaging protects the contents from any external factors, such as physical, chemical, or biological influences that could potentially alter the properties of the products.
In the pharmaceutical industry, packaging differs from drug to drug and is classified into primary and secondary packaging.
Primary Packaging: Primary packaging is the packaging in direct contact with the product. It is often referred to as retail packaging or POS (point-of-sale) packaging. The main purpose of primary packaging is to preserve the product and inform the consumer. Examples include ampoules and vials, pre-filled syringes (PFS), IV containers, blister packs, etc.
Some of the most common types of primary pharmaceutical contract packaging are:
Secondary Packaging: Secondary packaging refers to the packaging that protects the primary packaging, such as cartons, boxes, shipping containers. Secondary packaging is important for several reasons, including physical and barrier protection, brand exposure, easy product handling, ensuring regulatory compliance and the safety of the patients. Additionally, it facilitates the transportation of goods from the manufacturer to the end user.
Secondary packaging includes vital information such as ingredients, manufacturer details, warning, and the type of medicine. Secondary packaging offers several benefits, including streamlining the shipping process and reducing the risk of damage during transportation.
The various types of secondary packaging include, but are not limited to the following:
Cartons
Plastic Crates
Boxes
Trays
Bundles & Wraps
A drug product is carefully formulated to ensure the maximum therapeutic benefit. However, when the drug product interacts with its packaging, there is a possibility of it being chemically altered, which can potentially diminish its therapeutic benefit.
Pharmaceutical and biotech companies face several challenges when it comes to packaging. These include ensuring proper handling and transportation of the products, retaining the medicinal qualities of the products, providing important information related to medication, incorporating scannable codes for effective inventory management, addressing child-safety issues, adopting eco-friendly packaging solutions, accommodating new biologics, promoting sustainability, preventing counterfeit products, and promoting awareness and education among medical practitioners and consumers.
In addition to these challenges, some regulatory requirements like anti-tampering measures, adherence to multi-layered labeling regulations, and compliance with pharmacopeia standards to cater to the global market, play a crucial role.
Sharp offers various packaging solutions to address the above mentioned challenges faced by the pharmaceutical industry:
Sharp ensures product stability by providing the best commercial scale packaging solution for drug products. Using highly precise equipment, Sharp can handle the full range of bottle and solid oral dose shapes and sizes. It uses in-line fill sensors and check weighers to confirm fill count accuracy.
Its bottle packaging services encompass component sourcing, carton printing and in-line cartoning or bundling, comprehensive onsite engineering and validation support, serialization and aggregation, and strict quality control, to ensure that drugs are packaged to the highest standards.
Extensive expertise, a thorough understanding of global regulatory and compliance challenges, and comprehensive capabilities has established Sharp as a market leader in pharmaceutical oral solid dose blistering. Its packaging design team uses cutting-edge software and technology to provide comprehensive services that ensures the packaging of a drug is patient-friendly and that the product stands out in the market.
Sharp specializes in cold chain storage, packaging in temperature and light-controlled environments, serialization, and specialty distribution. Sharp offers contract pharmaceutical packaging services for a wide range of injectable devices, including vials, autoinjectors, pen assembly, pre-filled syringe (PFS), etc.
Sharp's global design team collaborates with clients on their product specifications, proposing the best packaging solutions for vials, pre-filled syringes (PFS), and autoinjectors for drug launch and sampling programs. Sharp offers a diverse range of customized kitting solutions for biotechnology, pharmaceuticals and medical devices, that require the packing of multiple components into a single self-contained package.
With a focus on quality processes, Sharp specializes in providing packaging services, Sharp has extensive expertise in die-cutting and pouching sublingual and oral dissolvable films and transdermal drug delivery systems. Backed by decades of experience in contract pharmaceutical packaging, Sharp combines comprehensive capabilities with quality operations and project management expertise to deliver the best packaging solutions for protecting specialty drug formats.
For gene therapy products, Sharp provides commercial packaging solutions that include batch sizes as small as 1 vial, just-in-time or better on-demand processes, fast turnaround times for packaging, labeling and distribution as well as cold, ultra-cold or even cryogenic storage.
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