Pharma & Biopharma Manufacturing
We seek to understand the goals you have for your drug and then provide the solutions that will help you overcome your development and manufacturing challenges. With the right products, services, and guidance we can help you improve process economics, accelerate time to market and mitigate production risks.
Whether you are manufacturing the therapies of today or the cures of tomorrow, we look forward to putting our years of expertise to work for you.
Our broad range of GMP products covers pharmaceutical raw materials for the development and manufacturing of solid, semi-solid and liquid dosage forms for small and large molecules. Additionally, we offer a portfolio of drug delivery compounds (DDCs), as well as solutions for solubility enhancement and controlled release.
Speed up your raw material qualification process and benefit from our application know-how and regulatory support consisting of the comprehensive Emprove® Dossier Library.
Ultrafiltration & Diafiltration
Ultrafiltration & diafiltration are important steps throughout bioprocessing to increase capacity, concentration, and recovery. Increasingly, single-pass tangential flow filtration (SPTFF) is being implemented in continuous or intensified processes to reduce in-line volumes.
Our industry leading TFF portfolio includes filters, hardware, and systems for a range of high value applications and demanding processes that require unbeatable performance and consistency.
Chromatography Systems for Bioprocessing
Downstream purification in bioprocessing includes one or more chromatographic separation steps to purify your molecule and remove impurities. Our broad chromatography portfolio includes resins, membranes, columns, and systems that work seamlessly together to simplify your workflow from process development to production scale.
Backed by unparalleled applications expertise and comprehensive support, we provide the confidence you need to tackle any chromatography challenge in your downstream process to increase productivity and improve efficiency.
Viral safety is a critical aspect of biologics production and relies on the principles of "prevent, detect and remove" to assure viral safety of drugs for patients. Preventing contamination of upstream cell culture processes relies on sourcing and testing raw materials and different technologies to remove viral contaminants. Downstream purification includes steps that either remove or inactivate viruses to provide the clearance required to assure viral safety.
Our viral clearance portfolio includes the virus filtration solutions, chemicals, holders and systems you need to assure reliable viral safety for your production process.
Clarification & Harvest
Clarification steps prepare your bioreactor harvest material for downstream purification by reducing the levels of impurities and particulates. Selecting the right separation technology depends on the properties of your fluid stream, process scale, and downstream processing steps.
Our clarification portfolio has options for every process and encompasses the filters and holders, pretreatment solutions, and hardware & systems you need to achieve efficient, robust, clarification to maximize success of your downstream operations.
Our Bioprocessing systems include an extensive range of products to meet your unique manufacturing needs. From single-use to multi-use, upstream to downstream, our portfolio of bioprocessing systems has a solution to support every step of your manufacturing journey.
Sterile Filtration & Bioburden Control
Bioburden control in pharma and biopharma processes is critical to assuring the microbial safety of drugs for patients. Bioburden reduction and sterilizing filters are integral components of all bioburden control strategies. Our broad portfolio of membrane filters offers options for efficient processing of every pharma and biopharma stream; from cell culture media through process intermediates to final sterile filtration. Our membrane filters offer the highest level of sterility assurance, are available in different formats, and are supported by comprehensive documentation packages to meet your compliance needs.
Robust fluid management systems mitigate the risk of process contamination. By combining our portfolio of single-use and multi-use systems, we can support your process needs. Our single-use portfolio includes assemblies, mixers and systems for large volume transport and storage. For multi-use facilities we provide stainless steel connectors, valves and mixers. A range of sterile connectors ensure closed connection and disconnection and our sterile sampling systems provide a reliable option for process monitoring.
Bioprocessing Cell Culture
Critical for the development and production of biotherapeutic products, cell culture for manufacturing requires scalable products that are traceable and pure yet economically sound. We are deeply committed to providing you with robust products to meet your mammalian cell culture needs. Our highly validated, optimized products, including upstream chemicals, supplements, chemically defined cell culture media, bioreactors and clarification filters, coupled with decades of expertise, provide convenient solutions to even the most complex challenges. We support you to maximize performance, speed, process economics and reduce risks, ensure business continuity and accelerate progress of drug candidates.
Buffer & Media Prep
Buffer and media preparation play a critical role in manufacturing operations affecting process efficiency, safety, and yield. Our comprehensive portfolio of high-quality cell culture media, buffers, and pH adjusters are supported by extensive, easily accessible, quality documentation packages to support risk assessments and meet your compliance needs.
Our single-use mixers are ideally suited for buffers and media prep and offer options for gentle mixing of protein and shear sensitive products as well as hard to dissolve materials and buffers. These mixers increase flexibility and production capacity by reducing start up time and minimizing process down time.
For bioburden control, our portfolio of time tested bioburden reduction and sterilizing filters can meet the buffer and media filtration needs for every process while our virus retentive filters offer an additional level of biosafety assurance for more critical applications.
Bioprocessing & Formulation Raw Materials
Process chemicals are key components for biopharmaceutical manufacturing. High-quality products, comprehensive documentation, and superior customer support facilitate your efforts in qualification, risk assessment, and process optimization to make your process development and manufacturing a success. Satisfy your regulatory requirements via our Emprove® Program
for the full range of products spanning the entire biomanufacturing process.
We provide industry-leading production know-how and comprehensive regulatory support for high-quality active pharmaceutical ingredients (APIs), backed by nearly 200 years of experience. Our commercial and late-stage APIs, as well as advanced intermediates, are primarily manufactured and purified at our cGMP site in Arklow, Ireland. The 64,000-square-meter facility includes extensive processing equipment, milling capability, testing laboratories, and state-of-the-art fractional distillation equipment. We have the resources and technical expertise to support you with new process evaluation, product registration and filing, process development and validation, technology transfer, reference standard synthesis, and regulatory filing support.