The adoption of disposables or single-use technology (SUT) in biopharmaceutical manufacturing is growing rapidly. SUT offers improved flexibility, reduced risk of contamination, and lower overall costs. Bags made from laminated polymers are used widely as disposable containers for the freezing and storage of bulk drug substance (BDS). But if the properties of a BDS require it to be stored at –70 °C, then fluoropolymer (perfluoroalkoxy (PFA) or fluorinated ethylene propylene (FEP)) bottles are the only choice because those materials have…

Antibody–drug conjugates (ADCs) are promising biopharmaceuticals. They combine the high selectivity and affinity to cancer cells with the toxicity of chemotherapeutics in one molecule. ADCs consist of a monoclonal antibody covalently bound by a linker to a highly potent cytotoxic drug. ADC-surrogates contain a nontoxic payload with similar structure and physiochemical properties as the toxic payload of an ADC. Therefore, they can be used as models to develop suitable purification processes or analytical methods. The ADC-surrogate in this work consists…

Avid Bioservices is a full-service, dedicated contract development and manufacturing organization (CDMO) focused on development and manufacturing of biopharmaceutical products derived from mammalian cell culture. Avid provides process development and CGMP clinical and commercial product manufacturing and offers expertise supporting analytical development, qualification, and validation activities. Additional service offerings include cell line optimization, cell culture and feed optimization, product characterization, and stability testing. Avid has 25 years of experience producing a comprehensive range of proteins, including monoclonal antibodies and recombinant…

Developing a long-term manufacturing-ready process for gene therapy and viral vaccine products can be a challenge for a number of reasons. First-in-human trials require developing a process with limited knowledge, and success metrics are unknown (e.g., assays to measure success have not yet been developed). In addition, the components of a treatment are difficult to buy or make, and in many cases, components of a process are rare and exist in very small quantities. Finally, such a process is difficult…

Capsule Delivery Solutions, part of Lonza Pharma and Biotech, is the leader in capsule-based solutions and services, proudly offering Capsugel® products. With the largest production and supply chain footprint in the industry, Capsule Delivery Solutions provides the highest quality and deepest regulatory expertise to its 2,000 pharmaceutical customers, globally. For more information, email solutions@lonza.com, visit www.capsugel.com and follow us on Twitter, LinkedIn, and YouTube. Just fill out the form to view a full PDF and learn more.

Pfizer CentreOne is a global contract development and manufacturing organization (CDMO) embedded within Pfizer. We focus on custom API synthesis, sterile injectable fill–finish, and highly potent oral solid dose; and we are a leading supplier of steroid and hormone APIs and intermediates. For more than 40 years, we’ve manufactured complex compounds for our biopharmaceutical partners, guiding their drugs safely from development through commercialization. The Value of the Embedded-CDMO Model: Your molecule is manufactured in the same facilities that produce Pfizer’s…

For over 25 years, Prometic Bioseparations Ltd (PBL) has produced chromatography adsorbents in batch sizes up to 280 L under cleanroom/good manufacturing practice (GMP) conditions at its Isle of Man (UK) manufacturing site. Following a sustained increase in demand for its chromatography products, PBL made the decision to expand its manufacturing operations to meet the projected future demand. During 2013, designs to expand the plant were developed. Between 2014 and 2017, a major investment focused on the expansion of PBL’s…

Rentschler Biopharma SE — located in Laupheim, Germany — is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company’s clients include innovative biotech companies and major pharmaceutical companies around the world. Rentschler Biopharma has long-standing experience and proven excellence as a solution partner of choice. A top-notch quality management system, well-established operational excellence, and advanced technologies ensure product quality at each development and manufacturing step. Rentschler Biopharma is a family-owned company with over 850…

Environmental monitoring, product quality control, and mycoplasma testing of biopharmaceuticals require anaerobic bacteria monitoring. If the proper environment is not created when performing microbial testing, bacteria will not grow, and a possible contamination could be missed. Any bacterial contamination of biopharmaceutical products can have major negative effects on manufacturing, production costs, and profit margins. A technology that relies on the evacuation and replacement of oxygen in a jar is valuable to the biopharmaceutical industry because it creates a quality-assured anaerobic…

Chinese hamster ovary (CHO) cells are the expression system of choice for the manufacturing of biotherapeutics. They have the capacity to express a range of proteins such as therapeutic enzymes or monoclonal antibodies at multiple gram per liter titers. As expression technologies have developed, obtaining such titers has been achieved mainly through improvements to media and feed. Similarly, the ability to identify high-productivity clones has been streamlined through the use of different selection systems, with metabolic selection being the preferred…