Upstream & Downstream Processing

Scaling-up AAV production? Take your time to develop best processes

The lack of standardization surrounding gene therapy production means process design can be more important than speed to clinic, says Oxford BioMedica’s CCO. The complexities of manufacturing monoclonal antibodies (mAbs) has been ironed out somewhat over the 30+ years of their presence commercially. But for the burgeoning gene therapy sector, there are no standardized mammalian-based platforms, for example, nor tried-and-tested upstream and downstream processes. “Viruses and viral vectors come in many shapes and sizes, each with their own characteristics,” Dave…

Generate Biomedicines raises $370m to advance AI drug discovery tech

Generate Biomedicines has raised $370 million to further develop its artificial intelligence (AI) drug discovery technology, expand its team and build labs. The Cambridge, Massachusetts biotech completed a series B round last week, attracting investment from founding backer Flagship Pioneering and the Abu Dhabi Investment Authority (ADIA), the Alaska Permanent Fund and Altitude Life Science Ventures. Generate said the money will allow it to “advance and evolve” the platform and “scale the organization with top-tier scientific and computational talent.” It…

Thermo Fisher and 3M team on chromatography tech

Leveraging Thermo Fisher’s single-use bioreactors systems with 3M’s purification platform aims to improve harvesting and clarification of monoclonal antibodies, the firms say. The collaboration – financials of which have not been divulged – allows Thermo Fisher to serve as an authorized reseller of 3M’s single-stage purification technology Harvest RC Chromatographic Clarifier with its own HyPerforma single-use bioreactor systems up to the 5,000 L scale. 3M’s tech is used to separate recombinant proteins, in particular monoclonal antibodies (mAbs) and according to…

Ins and outs: Avid create viral vector position to lead CGT expansion

CDMO Avid Bioservices has appointed Elie Hanania as vice president, process development, viral vector technologies to lead the company’s efforts in the CGT space. Sit back, relax, and enjoy this week’s Ins and outs. Biologics contract development and manufacturing organization (CDMO) Avid Bioservices turned to the production of viral vectors in October with plans to build a 53,000 square foot viral vector development and GMP manufacturing facility in Costa Mesa, California at a cost of around $75 million. Now, with…

Lose the LIMS? Bristol Myers says QC labs of the future need to be digital

Drug quality control labs of the future will need to be more closely integrated with manufacturing operations and make greater use of data management tech and automation, says an industry expert. Quality control is a vital part of ensuring drugs are safe, effective and can be produced consistently. However, despite understanding this importance, manufacturers have often focused on improving manufacturing processes rather than QC labs according to Steve Muller from Bristol Myers Squibb (BMS), who says firm’s looking to digitize…

Aceto buffers up presence in bioprocessing with A&C buy

A&C Bio Buffer is the sixth acquisition for Aceto in the past two years and signals the firm’s ambitions in the biomanufacturing services space. The deal, financials of which have not been disclosed, brings Aceto a GMP (Good Manufacturing Practices) manufacturer of custom buffer and chemical blend products used in the manufacturing of biopharmaceutical drug products, with a facility in Limerick, Ireland producing over 50 products including biological buffers, process solutions, cleaning solutions and WFI (Water for Injection). “A&C Bio…

Simulated Bed fellows: Tosoh buys purification firm Semba

Tosoh Bioscience says it will complement its resins business through the addition of continuous chromatography firm Semba Biosciences. The deal, which closed earlier this month, saw Pennsylvania-based Tosoh add all Semba’s staff and assets for an undisclosed fee. The acquisition will boost the firm’s downstream bioproduction portfolio, made up of chromatography resins, with the addition of Semba’s simulated moving bed (SMB) chromatography systems (see text box below). “Coupled with Semba’s revolutionary multi-column chromatography technology we have found a perfect complement…

MilliporeSigma says viscosity tech overcomes manufacturing challenges

MilliporeSigma has launched a Viscosity Reduction Excipient Platform, which it says helps tackle production and formulation issues associated with highly concentrated protein solutions. According to Merck’s Life Science business MilliporeSigma, the Viscosity Reduction Platform can address specific needs of different protein-based therapeutics through the combination of amino acids and anionic components. “MilliporeSigma’s new Viscosity Reduction Excipient Platform reduces interactions between proteins (including antibodies) that make the product too thick to pass through an injection needle,” Matthias Bucerius, head of actives and formulation at MilliporeSigma told us. “The platform does…

Gamma invests in bio-sensor and analytics firm Nirrin

Nirrin’s near-infrared spectrometry platform offers a reliable and cost-effective method of real-time analytics and will be leveraged across Gamma’s growing bioprocessing network, the firms says. Gamma Biosciences’s undisclosed investment in Maryland-based Nirrin Technologies brings access to sensors and analytics that support the bioprocess space, including automation tech with real-time, in-process monitoring for upstream and downstream applications. “This is a structured investment with longer term features that allow Nirrin to leverage Gamma’s resources and network in the near term as the…

ABEC launches TFF system it says can triple productivity

ABEC claims its Tangential Flow Filtration (TFF) system offers the largest flow rates and filter areas in the industry in a single-use format. ABEC’s Custom Single Run (CSR) Tangential Flow Filtration (TFF) systems were announced this week as an effort to increase downstream productivity for its bioprocess customers. According to the firm, the CSR TFF achieves flow rates greater than 240 liters per minute across cassette-type filter areas up to 40m2, effectively matching levels seen in stainless steel systems, tripling…