August 2013

Biopharmaceutical Product Development

Catalent is your strategic partner for biologic drug development success. We create smart, tailored solutions with our novel SMARTag™ antibody–drug conjugation (ADC) technology, our market-leading GPEx® cell line expression system, expanded biomanufacturing capabilities, and integrated development services to help you get better products to market faster. New SMARTag ADC Technology for Development of Optimized Antibody–Drug Conjugates — Superior Technology for Treatments in Development: Catalent has entered into an exclusive license and comarketing agreement with Redwood Bioscience to offer customers SMARTag…

Downstream Scale-Up Purification of Influenza Virus Using ReadyToProcess™ Equipment

The vaccine manufacturing industry is continuously seeking more flexible and time-saving solutions for a quicker response to pandemic outbreaks (1, 2). For influenza, vaccine is traditionally produced in fertilized hen eggs and purified in fixed steel equipment. Here we describe the scale-up of a downstream purification process of cell-based influenza virus, from a 10 L cell culture to the purification from a 50 L culture using ReadyToProcess single-use technology. Single-use technology reduces the need for time-consuming device preparations, such as…

Georgia, USA

Georgia’s strong and growing fill and finish sector includes access to an extremely talented workforce and world-class global infrastructure for cold chain, logistics and transportation. World-Class Distribution and Logistics Infrastructure Cold-Chain Storage in Georgia 70 cold-chain facilities 90% of the top 25 global third-party logistics providers (3PLs) Operations for four of the top five global public refrigerated warehousing companies Four major US interstates enabling companies to reach 80% of the US market by truck in less than two days Georgia…

Designing Quality into the Product

The ultimate objective in the development of any new therapeutic candidate is the validation of its mechanism of action and therapeutic efficacy in a clinical setting. Three important areas of product development are critical in determining the success of a new drug candidate: manufacturing, safety, and delivery of the product to patients. Early attrition observed during preclinical and initial stages of clinical development fundamentally resides in problems with manufacturing, stability, or safety issues. A Potential Risk for Everyone: The Cost…

Validation of the New Single-Use Freeze-Pak™STS

Figure 1:  Production of biologics — whether for clinical development or large-scale manufacturing campaigns intended to be converted to final drug product — often involves frozen storage. It provides manufacturing process flexibility while enabling long-term product stability. Products are frozen and stored using a number of technologies: stainless-steel vessels, bottles, carboys, and disposable bags. Although single-use freezing bags are a common choice for storing biologics, challenges with durability persist. Single-use bags intended for freezing and storage are often made with…

EcoPrime

Table 1:&#8 LEWA developed its first pulseless pump for liquid chromatography in the late 1970s and delivered its first chromatography system in the early 1980s. LEWA is the leader in supplying pumps used for pilot and industrial HPLC, SMB, and LPLC chromatography worldwide. A customer came to us several years ago requesting a low-pressure liquid chromatography system with a flow range of 20–2,200 L/h. They also wanted the ability to achieve linear gradient from 1 to 99%. We designed and…

Contract Manufacturing with Eastern Advantages and Western Standards

Kemwell Biopharma is a single-source service provider supporting early product development to commercial supplies of biopharmaceutical products. Founded in 1980, Kemwell is a 100% customer-oriented company with expertise in contract development and manufacturing services for pharmaceutical and biopharmaceutical products. Throughout its journey, Kemwell has maintained its pure-play status as a 100% contract services provider. Their core values and work culture being: “Customer Comes First. Always.” Kemwell has been successfully serving Big Pharma customers, including AstraZeneca, Bayer, GSK, Merck, Novartis, Pfizer,…

E. coli Cultivation in a 12L and 120L CELL-tainer™ Single-Use Bioreactor

Although single-use bioreactors are widely applied in the biopharmaceutical industry, microbial cultivation in them is restricted due to limitations in oxygen mass transfer, mixing, and heat transfer. The CELL-tainer™ single-use bioreactor makes use of an innovative principle applying a two-dimensional (2D) rocking motion, thus providing excellent mass transfer, making this single-use reactor very suitable for microbial cultivation at different scales. With a simple pillow-shaped bag without moving parts, the technology is robust and leads to cost savings compared with other…

Affinity Chromatography Applications with Single-Domain Antibodies

Figure 1:  Current downstream processing strategies for recombinant proteins often require multiple chromatographic steps, which may lead to poor overall product yields. Product purification can be especially difficult when a target protein displays reduced stability, has isoforms or misprocessed variants, or needs to be purified from a complex mixture containing a high level of impurities. Through highly specific antibody–antigen based interactions, affinity chromatography brings significant technical advantage to these protein purification challenges. Developed to tackle such challenges, CaptureSelect™ technology is…

Bio on Demand

NNE Pharmaplan has developed a new facility concept called Bio on demand™, which enable facilities to be established in one to two years. The result is a flexible facility that is fully operational and locally compliant, with functioning quality systems. Bio on demand™ involves a high degree of single-use technology to ensure cost-effective production and fast establishment. Facilities based on our Bio on demand™ concept can be delivered globally, but they are primarily intended for growth markets where time to…