Final preparation of manufactured biopharmaceutical drug products and vaccines involves formulating the active ingredients, whether derived from biotechnology, chemical synthesis or plasma purification, with any additional materials needed to present the material to the patient.
Pall provides a broad range of products that safeguard drug and vaccine products during these final operations so that the finished product, whether filled in vials, blister packs, form-fill-seal packs, pouches or syringes is free of particulate and bioburden.
At the final stage of the process, it is critical that the product is not altered by the filters used, and attention is paid to choosing filters that minimize both leaching of extractable filter materials into the product and adsorption of drug formulation components onto the filter. Recirculation of product through the filter back into the feed tank may be used to ensure that if there is any binding, it is saturated before filling begins. Pall’s Technical Services team is available to assist with filter selection and adsorption studies.
Sterilizing filtration and filling of sterile aseptic-filled drug products and vaccines is subject to close regulatory scrutiny. Pall maintains close contact with regulatory agencies and thought leaders to ensure Pall® filters and their uses confirm with regulatory expectations for Good Manufacturing Practices (GMP).
Use of Allegro™ Single-use Systems, including Allegro biocontainers with integrated tubing, manifolds, integrity test connections and filters provides a convenient way of handing the storage and final preparation of product prior to filling.
Additionally, Pall provides a number of additional components, such as disposable filling manifolds, and technical support and services to qualify and trouble shoot the final process.
Formulation may involve the final concentration and diafiltration of the product into a buffer that is suitable for injection. Pall® Tangential Flow Filter systems are incorporated into the formulation and filling suite for this purpose.
This final, critical process is typically carried out in clean rooms or isolators, where monitoring for contamination is a regulatory requirement. Pall® Pharmaceutical QC products play a vital role here.
Highly potent products, including many hormones and cytotoxics, require containment of all processing equipment to ensure operator safety. Pall offers a range of contained filter housings, GBK Containment Systems, for this purpose.
The final presentation form of the product may require a filter to be included in the hospital, doctor’s office or patient packaging so that the product is protected at the point of administration or where final formulation occurs in the pharmacy. Some products such as eye drops and nasal preparations require filters incorporated into the bottle. Pall has many customers who use our OEM service for these specialized filtration applications.
The final dosage delivery form of the drug may require a filter to be packaged with the product, for use in the hospital, pharmacy, doctor’s office or by the patient. These filters practice enable the product and patient to be protected at the point of administration or where final formulation occurs in the pharmacy. Pall has many patient-protection filters and product development services for these specialized filtration applications. View OEM materials and devices.