The commercial prefilled syringe line at Cook Pharmica can process up to 600 syringes per minute, 36,000 syringes per hour, or 70 million syringes per year. The automated, high-speed syringe line is fully enclosed in a barrier isolator to provide the highest level of aseptic processing available by removing the human element from the entire process. With the ability to operate in smaller batches or full-scale campaigning, the prefilled syringe line is capable of bridging clinical programs into commercial production.…

Mesenchymal stem cells (MSCs) are an attractive target for clinical study as therapeutic agents. However, current multilayer flatbed culture-expansion paradigms are cumbersome, time consuming, and typically limited in the ability to monitor cell characteristics during the growth process. We have used the Mobius® CellReady 3-L bioreactor in combination with microcarriers and human mesenchymal stem cells (hMSC) as a model. Following expansion, we have comprehensively compared the characteristics of cells grown in the bioreactor with those grown in standard two-dimensional (2D)…

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…

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,…

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…

Technology transfer (TT), the transfer of technical know-how from a product sponsor company to a contract development and manufacturing organization (CDMO), is the cornerstone of a fruitful working relationship between the parties. It is critical for successful advancement of the sponsor’s product development and commercialization efforts. Having worked with more than 100 clients over 14 years, PCT has performed nearly as many TT programs, underscored by the key success factors listed below. Communication: Upon establishing a collaborative sponsor– CDMO staff…

CRM197 is a nontoxic mutant of diphtheria toxin containing a single amino-acid substitution of glutamic acid for glycine. CRM197 is a well-characterized carrier protein used in a number of approved and highly successful conjugate vaccines including Pfizer’s Prevnar® pneumococcal vaccine, a multibillion-dollar franchise; HibTiter® (Haemophilus influenzae b) vaccine, and Novartis’ Menveo® meningococcal vaccine. Traditionally, CRM197 is produced by fermentation of a Corynebacterium diphtheriae C7 (β197) tox (–) strain, which secretes it into the culture supernatant. It is then recovered after…

Identifying the most appropriate contract manufacturer that is most likely the best match for your lead pharmaceutical candidate is a true challenge. Rentschler is a biopharmaceutical manufacturer with over 35 years proven track record. Focused on mammalian cell lines, our experience covers the development, production, and aseptic filling of recombinant proteins such as cytokines, enzymes, monoclonal antibodies, and fusion proteins in compliance with international GMP standards (EMA/FDA). We don’t just claim to be reliable and experienced; our many successful projects…

Richter-Helm has more than 25 years of experience in the development and good manufacturing practice (GMP)-compliant production of a wide range of biopharmaceuticals, including recombinant proteins (e.g., cytokines, growth factors, antibody fragments, surface antigens) plasmid DNA microbial vaccines (e.g., attenuated whole cell vaccines). Customized Solutions Richter-Helm offers customized solutions for all steps in biopharmaceutical projects through contract development and manufacturing services featuring Development of production strains (Escherichia coli, Pichia) Establishment of MCB/WCB Development of fermentation (1 to 1,500 L) and…

Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than two decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offers a broad variety of integrated services including innovative expression systems, process development, scale-up, and production of recombinant products derived from microbial systems and mammalian cell culture in state-of-the-art facilities. Our expertise is based on numerous projects successfully performed in collaboration with our customers. Currently, Sandoz is…