The biopharmaceutical industry is increasingly using disposable single-use systems for both the development and manufacture of numerous vaccines, therapeutic proteins and monoclonal antibodies (mAbs). What devices are available on the market? What advantages do they offer? For which applications? Pemflow provides an overview.
Innovative and easy-to-implement systems
Biopharmaceutical processes are complex and involve numerous steps, including filtration steps. In these industries, requirements in terms of purity, quality and regulatory compliance are extremely stringent. In this demanding context, single-use systems, or SUS (single use systems), offer multiple advantages: reduced capital expenditure, reduced equipment changeover time on production lines. They also provide flexibility in processes.
In processing industries (pharmaceutical products but also food processing) requiring frequent and regular equipment cleaning, SUS make it possible to eliminate lengthy and costly clean-in-place (CIP) and sterilisation-in-place (SIP) procedures.
The validation steps required when using reusable stainless-steel systems also become unnecessary when SUS are implemented.
In the field of research and R&D, SUS allow researchers and process engineers to work with different molecules—antibodies, proteins, vaccines, etc.—within the same installation. This is a significant advantage when transitioning from the laboratory to market for new drugs.
Ready to use, cost-effective and flexible, single-use systems eliminate the purchasing, maintenance and cleaning costs associated with stainless-steel filter housings and remove the need for CIP/SIP procedures.
Controlling extractables
Like any device in contact with a biopharmaceutical product, SUS may potentially release compounds into the product or interact chemically with it, altering its purity, composition and potentially its efficacy, or even rendering it unfit for commercialisation. Controlling the nature, quantity and fate of extractable substances from SUS, which are made of polymers, is therefore a major concern.
It is therefore the responsibility of the manufacturer using them to quantify these elements and their subsequent impact on drug purity. To do so, it is essential that the SUS supplier provides detailed information on extractable substances, which is required for leachables studies.
Using, for example, gas chromatography coupled with mass spectrometry (GCMS) or liquid chromatography coupled with mass spectrometry (LCMS), the supplier can accurately characterise the various components of the SUS for volatile, semi-volatile and non-volatile extractables, across several extraction media and under different time and temperature conditions.
SUS devices in practice: bags, filters and sampling systems
SUS therefore meet a wide range of requirements and constraints: microbial retention, sterility, endotoxin filtration, biosafety, etc. Existing devices are also designed to operate over broad ranges of flow rate, burst resistance, temperature, pressure and pressure drop.
In practice, disposable single-use devices are very diverse in nature. They may include sterile bags, sampling systems, filtration devices (notably filter capsules), tubing, connectors, etc.
2D & 3D sterile bags are used for the storage and transfer of sterile media, intermediates, sterile buffers with a wide pH range, sterile drug substances and formulations.
The storage and transfer of these fluids during and between process steps, as well as between different process areas, is particularly critical. Pre-sterilised disposable single-use storage and transfer systems meet regulatory requirements while preserving the nature, strength, quality and purity of the fluids.
Sterile bags are manufactured from a multilayer polyethylene film that is highly inert to the chemicals and solvents used in the biopharmaceutical industry. They provide an excellent barrier to oxygen, CO2 and moisture.
Single-use aseptic sampling systems, gamma-irradiated, are used for the aseptic sampling of fluids at various stages of pharmaceutical and biopharmaceutical processing. They can address the following needs:
sterile bulk and sterile transfers, vaccine formulation at different maturation stages, fermentation cycles, cell culture from bioreactors.
Multiple tubing options in thermoplastic elastomers (TPE) as well as platinum-cured silicone are available, in a wide range of internal and external diameters to meet all requirements.
Finally, filters, and in particular filter capsules, are especially suitable for prefiltration, microbial load reduction and sterilising filtration.
Focus on single-use sterilising capsules
Filter capsules, also known as monobloc filters, available in various formats and media types, are offered in gamma-sterilised or non-sterilised versions. Ready to use and particularly suited for development and pilot phases where batch filtration is required, they provide ease of use that is highly appreciated by operators.
They are used during prefiltration, microbial load reduction, sterilising filtration and final filtration steps, from sample preparation to larger batch packaging. The filtration unit is enclosed within a filter capsule, limiting installation or maintenance operations and operator exposure. They can be supplied pre-sterilised for immediate use in an aseptic environment.
Find out more about filter capsules
Disposable single-use filter capsules use media made of PES, PP, hydrophilic or hydrophobic PVDF, PTFE, glass microfibre, nylon or charged nylon. Suitable for gas and liquid filtration, they are available in various pore sizes, lengths and connection types, covering a filtration rating range from 0.1 to 20 μm. Available filtration areas vary widely, from small 5 cm² capsules with very low hold-up volumes to filters offering up to 18,000 cm² for large-scale production.
For all filter capsules, inlet/outlet connections may be standard or customised. Capsule filter media are housed in shells made of polypropylene, polyetherimide, polycarbonate, etc.
Hydrophilic membrane capsules made of PES or PVDF are particularly recommended for sample preparation, clarification and microfiltration of cell culture media, both in upstream and downstream operations. Whether for sterilising filtration of pH adjusters, growth regulators, antibiotics or vaccines, these sterilising membranes are compatible with ethylene oxide sterilisation, gamma irradiation and autoclaving.
Hydrophobic membrane filters are used for gas filtration under pressure or as tank vents. Their PTFE or polyvinylidene fluoride (PVDF) membranes reliably remove contaminants and microorganisms in sterilisation applications.
There are also filter capsules specifically designed for higher flow rates. With low protein adsorption, PES and PVDF media offer excellent chemical compatibility and an extremely low level of extractables, both at pilot scale and for larger production batches.
The manufacture of filter capsules must be carried out in a cleanroom (ISO Class 7), under a strict quality management system, to ensure full traceability and consistent production quality for the user. Each capsule must be supplied with an individual certificate of conformity.
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