Upstream & Downstream Processing

The evolving demands of the temperature-controlled supply chain for cell and gene therapy

As drugs have become more complex, so too has the supply chain, which must innovate to accommodate the necessary, specialized conditions for the storage and transportation of these drugs, even under extenuating circumstances. As the pharmaceutical industry shifts its attention to biologics and cell and gene therapies, the need for more advanced storage solutions has heightened considerably. In January 2019, former commissioner of the U.S. Food and Drug Administration (FDA) Scott Gottlieb, M.D. issued a statement regarding the impending cell…

Repligen boosting single-use portfolio with Engineered Molding Technology buy

Repligen will add silicone single-use consumables and components for bioprocessing functions through the addition of Engineered Molding Technology (EMT). The size of the deal has not been divulged, but Repligen will expand its single-use filtration and chromatography system component portfolio with custom molded and over-molded connectors and silicone tubing products. “The acquisition of EMT expands our line of single-use ProConne® flow paths, streamlines our supply chain for ATF, and gives us more flexibility as we scale and expand our single-use…

CHO over? Biopharma and MIT team on alternative cell line R&D

Biogen, Amgen, Pfizer, Genentech and Sanofi have teamed with an MIT-led group aiming to develop new biomanufacturing cell lines and methods. The collaboration – known as the AltHost Consortium – will share research to explore innovative ways to produce biologics and vaccines for clinical usage in diseases from diabetes to cancer. Lead researcher Christopher Love from MIT likened the collaboration to the early days of the biopharmaceutical industry. “When biomanufacturing first emerged as a field, shared knowledge across laboratories was…

Cytiva bolsters CDMO business with MA expansion

Cytiva has upgraded its Fast Trak facility in Marlborough in response to demand for pre-clinical to Phase II biomanufacturing services from small to mid-sized companies. Under the firm’s Fast Trak contract development and manufacturing brand, Cytiva has expanded its Marlborough cGMP facility to 60,000 square feet. The plant offers biopharma access to services from preclinical to Phase II, including process development, clinical batch manufacturing, analytical development, and QA/QC/regulatory support. Olivier Loeillot, senior vice president of BioProcess at Cytiva, did not…

COVID-19 vaccine rush magnifying glass demand, says Stevanato Group

Gerresheimer, The Stevanato Group, and SCHOTT have pledged to safeguard the supply of glass vials as demand from COVID-19 related projects gets set to skyrocket. All parts of the biopharma supply chain will be called upon to support the increasing numbers of COVID-19 vaccines entering and progressing through the clinic. As such, three glass and primary packaging firms have come together to issue a statement promising to work together and with industry to ensure supply of such elements throughout all…

COVID-19 vaccine: A $14bn opportunity for bioprocess vendors

The big four bioprocess vendors – Thermo Fisher, Danaher, MilliporeSigma, and Sartorius – are set to benefit from the commercial success of COVID-19 vaccines, according to Evercore ISI. There are a host of vaccine candidates targeting the novel coronavirus (SARS-CoV-2) moving into and through the clinic, and while there is no guarantee of success a breakthrough product will be a lucrative market opportunity. Specifically, a commercialized product could be worth upwards of $100 billion (€89 billion), according to the team…

Cytiva shares tips for viral vector production

The viral vector market is highly active, and the interest in production technologies is driven by recent approvals in cell and gene therapy, says Åsa Hagner-McWhirter, senior scientist at Cytiva. Demand for viral vector production is high. The main driver is the large pipeline in different clinical stages and scales. In 2018 there were 724 clinical trials for gene therapies and gene-modified cell therapies, many of which use viral vectors. Adenoviruses and retroviruses, including lentivirus, are frequently used. Adeno-associated virus…

Prefab facilities could feed the need for COVID vaccine capacity, say Univercells and Exyte

Exyte and Univercells Technologies have teamed to develop and construct modular GMP vaccine manufacturing plants that can be deployed in a third of the time of conventional facilities. As vaccines against COVID-19, caused by the SARS-CoV-2 virus, begin to move through the clinic at an unprecedented speed, the question is rising as to how industry can scale-up production. At the heart of this is ensuring capacity is available to produce millions, if not billions, of doses of a potential vaccine.…

Cytiva to help Takara gear up for COVID-19 vaccine production

Cytiva will help Japan’s Takara Bio prepare manufacturing processes for a DNA-based SARS-CoV-2 vaccine candidate. Cytiva announced the collaboration this week, explaining it will work with Takara and partners Osaka University and AnGes to develop production processes and technology for the vaccine. Stephane Perrey, general manager for Cytiva in Japan, Australia, and New Zealand, told us “Cytiva is providing process design consultation, prioritization of equipment manufacturing and prioritization of consumables manufacturing. “We worked closely with Takara Bio to help them…

Rapid Micro Biosystems to fund EU facility construction with $120m fundraising

US sterility testing tech firm Rapid Micro Biosystems will build a European plant and expand its business with $120 million raised this week. The Lowell, Massachusetts firm – which makes automated microbial detection systems – completed a $120 million financing round this week, attracting equity investment from The Ally Bridge Group, Endeavour Vision, and existing investors including Asahi Kasei. CEO Robert Spignesi told Bioprocess Insider the firm’s “growth plan includes establishing new manufacturing capacity, beyond our current US manufacturing facility…