Infringement is the unauthorized copying of patented subject matter. Infringement can be either direct or indirect (e.g., induced or contributory), and the issue becomes complicated when the patented subject matter relates to methods. To illustrate, consider the fictional J.P. Jones, PhD, who has developed a burgeoning business in the bioinformatics field by dividing the practice of patented methods amongst several actors. Dr. Jones encouraged medical practitioners to augment their diagnostic resources by utilizing his for-profit laboratory to perform specific DNA analyses. The diagnostic methods collectively being followed by the clinicians and the independent laboratory were patented by another company, but in dividing performance of the method steps among the clinicians and the lab, Dr. Jones was able to ignore the patent rights by exploiting what has often been perceived as a loophole in US patent law. Under these circumstances, the patented protocols were not directly infringed. Consequently, Dr. Jones could not be held liable for inducing patent infringement. However, a September 2012 Appellate Court decision has changed things for Dr. Jones and his contract research organization (CRO.
BioProcessing Journal Posts
Induced Patent Infringement Breaks Free from Direct Infringement: The Implications for Bioprocessing
With growing interest in process intensification in the biopharmaceutical industry, implementing cost-effective purification strategies has become increasingly important, particularly for the expensive protein A affinity capture step in monoclonal antibody production. This study compares traditional resin-based batch chromatography (rbBC), multi-column chromatography (MCC), and membrane chromatography (MC) using small-scale experiments with commercially available formats. Performance metrics including yield, elution volume, and impurity reduction were evaluated. The best-performing conditions for MC and MCC were used to project cost and productivity for mAb purification at the 1,000 L bioreactor scale. Both MC and MCC demonstrated significant advantages over rbBC. MC achieved the highest productivity (234–236 g/L/h, 19–20-fold higher than rbBC) and the lowest media costs, resulting in up to 91% reduction in cost-of-goods (CoG) per batch. MCC also showed notable improvements, with 4.6–5.1-fold higher productivity than rbBC, and up to 72% CoG savings. Due to its operational similarity to rbBC and compatibility with existing infrastructure, MC was selected for further evaluation. Optimization was performed using a 3.5 mL membrane over 50 cycles, followed by scale-up to a 58 mL membrane tested on a pilot-scale skid representative of clinical or commercial manufacturing. The process was successfully run for 55 cycles, demonstrating comparable yield, impurity reduction, and elution profiles to rbBC. These results support the feasibility of membrane chromatography as a scalable and economical alternative for protein A capture in intensified downstream processing.
In biopharmaceutical manufacturing, buffer preparation is traditionally performed manually by dissolving solid salts in water for injection (WFI) followed by offline mixing and specification testing. This method requires large buffer volumes, extensive infrastructure, and significant labor, often creating bottlenecks in production. To address these limitations and support process intensification, inline buffer preparation technologies have emerged…
The number of cellular therapies in clinical trials and on the market has continued to rise significantly in recent years—and so does the need to maintain strict control over all manufacturing steps in order to reduce batch-to-batch variability. One potential source of product variability is the manual thawing of cryopreserved cells in a water bath, which can differ between operators. Additionally, water baths pose a significant contamination risk, making them less suitable for GMP environments. To overcome these challenges, several companies have developed water-free thawing devices that offer better control of the thawing process. However, these devices either accommodate only one vial at a time or lack U.S.
FDA 21 CFR 11 compliance in producing a computer-generated audit trail. Hence, we have developed a novel, water-free and dry-heat-based, fully programmable thawing device that is capable of thawing up to ten vials simultaneously and complies with 21 CFR11 requirements…
Polyß-hydroxybutyrate (PHB) is a heavy, molecular-weight polymer with monomer units of (R)-3-hydroxylbutyric acid (HBA) which is deposited as a storage component in many groups of microbes, and is an ecofriendly thermoplastic. Distillery spent wash (DSW) is an industrial waste which has elevated chemical oxygen demand (COD) levels but consists of valuable minerals that can be used for PHB production. Azotobacter vinelandii (ATCC® 12837â„¢ and ATCC 13705â„¢) was used to develop A. vinelandii UWD, which is a hyper PHB-producing mutant, by using N-methyl-N’-nitro- N-nitrosoguanidine (NTG) mutagenesis. This strain was grown in a fed-batch bioreactor containing diluted DSW at (1–7%) with 5% glucose as the carbon source, and ammonium acetate as the nitrogen source. The transformation efficiency for rifampicin (Rif)-positive colonies was 9 × 10-5 which was good enough to select the hyper PHB-producing mutants after five days of incubation. The amount of PHB produced in different dilutions of spent wash was highest (40 g/L, 92% w/w) with 4% spent wash. The glucose consumption was 89% w/w at 4% DSW, and the dry cell weight was > 23.4 g/L. In addition, elevated COD levels (1100 mg/L) of DSW were decreased to 200 mg/L after fermentation was completed. The spent wash, which is considered to be a production waste and ecological pollutant, can be consequently used for bioplastic production…
The purpose of this study was to explore extremozyme production optimization. We found that maximum cellusases were obtained after 72 hours at 55 °C and 4.8 pH. Fructose was determined to be the optimum carbon source and peptone was the nitrogen source for cellulase production. Further, Tween 80 was used as a surfactant and ammonium sulphate served as a mediator to enhance the production of cellulases by A. fumigatus. The enzyme produced was subjected to purification by ammonium sulphate precipitation and gel filtration chromatography. The maximum concentration of cellulase was purified with 40% ammonium sulphate and gel filtration chromatography which resulted in a 3.5-fold purification. The purified enzymes were characterized with regard to optimum pH, temperature sensitivity, substrate specificity, and kinetic parameters such as Km and Vmax. Cellulase reached maximum activity at 55 °C and 5.5 pH. Metal ions like Ca2+, Mg2+, and Zn2+ had positive effects on cellulase activity. The Km and Vmax were found to be 4.34 µ M/mL and 7.29 mM respectively…
The current gold standard for the detection and identification of microorganisms has been in place for over a century. Petri culturing has been a solid diagnostic platform and its impressive run through history has served us well. However, modern requirements are challenging this traditional technology. Pressures within clinical and industrial applications have personnel demanding faster results while labs are forced to wait lengthy periods of time for confirmation of viable bacteria growth, or no growth. Depending on the organism, typical culturing results require anywhere from 24 hours to 21 days. It is time to give our culture-based friend a modern makeover to build on its outstanding reputation and enable it to compete in the modern world…
Risks in the pharmaceutical supply chain are not solely related to the active pharmaceutical ingredients (API). On average, excipients used in formulating medicines comprise 80% of each product and include a broad range of substances such as antiadherents, binders, coatings, disintegrants, diluents, flavors, colorings, preservatives, and sweeteners. Pharmaceutical excipients aid in the manufacturing process to protect, support, or enhance stability and bioavailability, and also make the product acceptable to the patient. They may also assist in product identification and augment the overall safety or function of the product during storage or use. Excipients represent an annual market value of approximately $4 billion worldwide, accounting for 0.5% of the total pharmaceutical market, according to industry experts…