Quality Testing Product: Palltronic Flowstar IV instrument Applications: Filter integrity testing Features: The Palltronic Flowstar IV integrity test instrument is designed for speed and accuracy in laboratory and cleanroom operations. It offers up to date networking and automation options. Lightweight, ergonomic, and developed in accordance with both GAMP and 21 CFR Part 11, the instrument is supported by detailed qualification documentation and worldwide technical and aftersales support. Contact Pall Corporation flowstar@pall.com www.pall.com Anion Exchange Product: Toyopearl Q-600C AR anion-exchange resin…
Author Archives: BPI Contributor
IBC’s 24th International Antibody Development and Production
Antibody Development and Production is regarded as the most comprehensive event that delivers industry best practices across the spectrum of upstream and downstream processing. By attending, you will learn how companies are developing the latest molecular assessment approaches to optimize manufacturability and product quality and how they are applying smarter and faster tools for rapid process development. Industry leaders will assess the state of the industry and offer solutions to overcome the current capacity issues as they work towards their…
Global Marketplace
Inline Sampling Product: STA-PURE fluid sampling Applications: PAT sampling Features: Gore’s sampling system can be directly connected to 25-mm Ingold ports. Previously, such sampling required the use of TC adapters and O rings that can leak or get stuck in vessel ports. The STA-PURE solution uses a high-purity, highly compressible platinum-cured silicone adapter integrated with a single valve device. A single-use silicone sleeve is attached and presterilized with the device. When the valve body is inserted into a vessel port,…
Biopharmaceutical Development and Production Week
IBC’s Biopharmaceutical Development and Production Week covers today’s critical issues from all angles to provide you with a deeper understanding of the forces affecting your company and driving the bioprocessing industry. Customize your learning and networking experience with access to 700+ bioprocessing professionals under one roof 103 presenters to share strategies and lessons learned 45 exclusive case studies five shared plenary sessions two exhibit halls with >60 supplier companies. Together, these five conferences deliver the latest technical and scientific approaches…
Accelerating Bioassay Transfer in a GMP Environment
Most products in discovery by pharmaceutical companies today are biopharmaceuticals. Made by living organisms, these are typically large–molecular-weight products that rely on their secondary and tertiary structure for therapeutic effectiveness. Synthetic small molecules and biopharmaceuticals both require analytical verification for release, but only biopharmaceuticals require functional potency assays for investigational new drug (IND), biological license application (BLA), and new drug application (NDA) submissions. Those activities often require elaborate transfers of diverse, biological, product specific assays that carry greater chances of…
Using In Vitro Assays for Therapeutic Enzyme Characterization
A number of biopharmaceuticals are enzymes that act in vivo on high-molecular substrates. It can be a challenge to develop in vitro methods for accurately assessing their biological activity. Interest is also developing in using enzyme kinetic parameters as product quality attributes under the quality-by-design (QbD) initiative. Among biotechnology therapeutics, the conventional method of expressing potency is in units/mg of biopolymer. For enzymes, a unit of activity was defined in 1958 by the International Union of Biochemistry and Molecular Biology…
A Modular Approach to Facility Validation
Biopharmaceutical manufacturers are striving to maintain productivity and profits while controlling increasing costs. Historically, validation has been seen as an expensive, non–value-added necessity to gaining regulatory approval to manufacture. Less often is it seen as a key element of an overall quality management system (QMS) that supports the safety, quality, and efficacy of end products for patients while also providing invaluable knowledge and experience for enhanced process control and management. When fully integrated with a QMS, a modular validation platform…
Strategies for Implementing a BPC in Commercial Biologics Manufacturing
Biopharmaceutical manufacturers use a range of bioprocess containers (BPCs) during the production and storage of biopharmaceuticals. Plastic bags, bottles, flasks, and carboys are all types commonly used in bioprocessing (1). A suitable BPC must be able to maintain aseptic integrity and be constructed of materials that will not harm product efficacy and/or purity. The trend of “single-use” or “disposable” BPC technologies in the biopharmaceutical industry enables greater flexibility and better use of production facilities that are increasingly designed for multiple…
Fifth Annual Biopharmaceutical Manufacturing and Development Summit
According to a recent industry survey published in Pharmaceutical Manufacturing, the top three goals of most biopharmaceutical manufacturing companies are to improve in these areas: manufacturing agility, capacity use, and internal quality management. Close on the heels of those top three are improved alignment of internal goals with those of business partners, improved on-time delivery, and reduced inventory. The BMD Summit is the best forum to gain the data and consultation you need to enable you and your interdisciplinary team…
Global Marketplace
Disposable Component ID Product: Single-use tubing and molding components Applications: Biopharmaceutical manufacturing Features: The industry wants reliable identification of components in single-use products. AdvantaPure addresses that with identification solutions that include the AdvantaLabel molded silicone labeling system, PET process-equipment tracking, and GammaTag gamma-irradiation–sterilizable RFID tags. The new DocuLink identification product (patent pending) will soon be launched to provide users a way to reference batch, lot, and validation documentation after installation of a molded-silicone manifold. Contact AdvantaPure www.advantapure.com Hydrophobic Interaction Product:…