Upstream Processing

Antibodies, Bioassays, and Cells

It’s no surprise that immunochemistry forms a broad and solid basis of biopharmaceutical analytical laboratory work. Immunochemicals include antibiotics and antigens, nucleic acids and nucleotides, enzymes, lipids, antioxidants, probes and dyes, and proteins and peptides. Available from companies such as Advanced Immunochemical, Immundiagnostik, Lampire Biological Laboratories, and Rockland Antibodies and Assays, their many uses include antibody isotyping and fragmentation. Adjuvants, buffers, assay kits, target biomolecules, and phage-display systems support those applications. Because background and off-target effects complicate the study of…

Protein Scaffolds

The recent success of monoclonal antibodies (MAbs) as therapeutic agents to treat cancer, multiple sclerosis, rheumatoid arthritis, and other chronic inflammatory and autoimmune disorders (Table 1) has catapulted these once difficult-to-develop molecules to the forefront of modern molecular medicine (1, 2). The size of the global MAb market in 2008 was valued at almost US$28 billion. Industry analysts predict that the size of the MAb market will grow to almost $68 billion by 2015, with the largest growth occurring in…

Evaluation of a New Single-Use UV Sensor for Protein A Capture

As the adoption of single-use systems continues to expand beyond bags and tubing to complete process steps, a full range of sensing technologies will be needed to complement the resulting varied single-use applications. Single-use sensors must meet or exceed the performance of traditional sensing technologies in areas such as accuracy, response time, ease of use, control system integration, process compatibility, regulatory requirements, and cost. Single-use flow-through process sensors are currently available for pressure, temperature, flow, and conductivity. Here, we report…

Vendor Voices: Flexible Manufacturing

One strong take-away message from BPI’s flexible facilities supplement (December 2012) is that there is no single road to achieving a flexible manufacturing process. The ability to quickly modify a unit operation, process line, or entire facility to accommodate change certainly depends on several factors. Flexibility is no longer exclusively linked to single-use systems for one specific operation. It connects facility design, staffing models, and revamped technologies. Vendors and suppliers are hearing first-hand what the industry wants in flexible operations.…

Process Optimization of Biosimilars Production Using NMR Profiling

With a compound annual growth rate potential of ∼52% during 2010–2015 (1), the global biosimilars market represents a significant driver in biologics development and manufacture. Increased competition, quality-by-design (QbD) directives, and rising costs are compelling biosimilars manufacturers to search for advanced technologies they can use in optimizing production processes to remain competitive and maximize new opportunities. Here, we discuss biomanufacturers’ needs for robust, standardized cell-culturing procedures that comply with QbD directives. We also describe an effective new NMR-based bioanalysis technology.…

Rapid Detection of Pandemics

A Coronavirus — like severe acute respiratory syndrome (SARS) — is back in the headlines. On returning from a trip to Saudi Arabia in summer 2012, a Qatari national was struck down by a mystery respiratory illness. Because of inadequate diagnostic capabilities, the patient was transferred from Qatar to London for intensive-care treatment and diagnosis. The UK Health Protection Agency (HPA) confirmed infection with the same Coronavirus strain discovered by a Dutch team following the death of a Saudi national…

A High-Yielding, CHO-K1–Based Transient Transfection System

Biotherapeutics have emerged as effective treatments for many diseases. It’s estimated that every year hundreds of new biotherapeutic candidates enter development (1). Stable transfection of host cells to establish high-producing cell lines is the approved method for generating clinical-grade recombinant biologics. However, biotechnology companies needing to speed up their developmental timelines are increasingly relying on material generated using transient transfection (1, 2). Unlike stable gene expression (SGE) that requires several months of laboratory and process work, transient gene expression (TGE)…

Analysis of Bacterial Biomass Growth and Metabolite Accumulation

Mathematical modeling has been widely used in microbiology and biotechnology for several decades. The main objective of modeling is to find optimal conditions for microbial growth and biosynthesis of useful metabolites. We modified the well-known equation of Perth–Marr (1) — proposed to calculate the energy consumption of a substrate— to analyze the energy consumption by cells for growth and viability maintenance. Our study includes that theory along with our own development. Our initial modeling work was carried out with Yersinia,…

Screening Yeastolate Raw Material Used in Insect Cell Culture Media

Insect cell culture is widely used as an industrial platform in recombinant protein production for research and diagnostics (1, 3,4,5). Many commercial yeastolate products are intended as nutritional supplements for not only insect cell culture, but also for mammalian cell culture and bacterial fermentation applications (6,7,8,9,10,11,12,13,14,15). Yeastolate plays an important role in modern biological production because it can be very effective in promoting insect cell growth and enhancing production of recombinant proteins. The product is known to contain amino acids,…