Author Archives: Millie Nelson

Lonza: ‘Get CGT processes correct early to avoid late-phase pitfalls’

Lonza says its expertise in the cell and gene therapy space can help sponsors quickly bring products into the clinic and towards commercialization. Contract development and manufacturing organization (CDMO) Lonza is a major player in the advanced therapy space, with facilities in Geleen, The Netherlands and Houston, Texas – the latter described by the firm as the world’s largest dedicated cell and gene therapy manufacturing plant. Speaking at the Cell and Gene Manufacturing and Commercialization (CGMC) Conference in Amsterdam, The…

The CDMO space does not have the capacity to meet fill-finish demand, says Lonza

Pipeline expansions are placing pressure on fill-finish capabilities and have caused a surge of investment in infrastructure, says Peter Droc, head of drug product services at Lonza. Swiss contract development manufacturing organization (CDMO) Lonza has made a string of investments to bolster its fill-finish capabilities. In July 2022, the firm forked out $521 million to construct a commercial large-scale fill-finish facility at its site in Stein, Switzerland. And less than a year before this – at the same plant –…

Polyplus adds plasmid DNA CDMO Xpress Bio to upstream toolbox

Polyplus tells us how such additions as plasmid DNA maker Xpress Biologics bolsters its upstream offering and can help reduce the costs of cell and gene therapies. The deal sees cell and gene therapy upstream solutions firm Polyplus add Belgian contract development and manufacturing organization (CDMO). Financials have not been disclosed, but the acquisition brings plasmid DNA and protein production using microbial expression systems to Polyplus’ engineering technology and services portfolio and will bolster the firm’s ambition to improve gene-therapy…

MilliporeSigma bolsters bioreactor offering with Erbi buy

The acquisition of Erbi Biosystems will enable MilliporeSigma to offer a full range of bioreactors ranging from 2 ml to 2,000 L, says firm.   MilliporeSigma – the life sciences division of Germany’s Merck KGaA – has acquired Massachusetts-based firm Erbi for an undisclosed fee. According to the bioprocess vendor and contract development and manufacturing organization (CDMO), Erbi’s 2 ml micro-bioreactor platform, Breez, will strengthen its upstream portfolio.  The Breez bioreactors operate by using miniaturized valves, filters, mixing, pumps, and sensors to perform…

Samsung Biologics eyes up ADC market for 2023

Samsung Biologics says it is looking at moving into the ADC market and has space free at its plant number four to add capability. It comes as no surprise that biopharma companies around the world keep an eye on trends and modalities that look to be promising, and Korean contract development manufacturing organization (CDMO) Samsung Biologics is no different. James Park, executive vice president of global sales at Samsung Biologics, spoke to BioProcess Insider at CPHI, Frankfurt and pointed to antibody…

Touchlight receives $2.4m to advance doggybone DNA platform

The Bill & Melinda Gates Foundation has awarded Touchlight $2.4 million in funding to further preclinical development of its doggybone DNA vaccine platform. According to Touchlight, the funding will be used to advance preclinical data that has shown the potential of nanoparticle-formulated doggybone DNA (dbDNA) to provide strong antibody titers and durable T cell responses following vaccine administration. Part of the grant will also be put towards investigating the performance of dbDNA for therapeutic monoclonal antibody (mAb) manufacturing. If the…

UK Uni to train frontline healthcare staff in CGT production

The center for Advanced Therapies Manufacturing Training at the University of Birmingham has introduced training courses aimed at bolstering the industry’s capabilities for advanced cell and gene therapy production.   The course programs are specifically aimed at frontline healthcare practitioners and consist of virtual reality (VR) training components to upskill staff to produce and administer advanced therapy medicinal products (ATMP’s) to patients. “The aim of the courses is to provide an introduction to CGTs and ATMPs with an emphasis on…

Sartorius and Exopharm to develop large-scale exosome tech

Sartorius BIA Separations (BIA) and Exopharm have signed a joint research agreement to address the technical challenges of large-scale exosomes for non-viral drug delivery. BIA – a chromatography firm acquired by Sartorius in October 2020 for $423 million – will use its Convective Interaction Media (CIM) monolith chromatography alongside Exopharm’s patented LEAP technology to advance large-scale therapeutic exosome production and commercialization. BIA claims its CIM monolith chromatography columns allow high-throughput, resolution separation, and capacity. Furthermore, the firm says it has…

Healiva to speed regenerative skin therapy launch with B.Braun asset buy

The acquisition of B. Braun Medical AG Switzerland’s manufacturing assets will advance the launch of personalized skin regeneration therapy, EpiDex, says Healiva. Healiva, a firm that delivers medicine for individuals with chronic and acute wounds, has acquired pharmaceutical device company, B.Braun’s, manufacturing assets for an undisclosed fee. The acquisition includes a qualified cell bank, which Healiva says is vital for the GMP-compliant production of its first cell therapy product, EpiDex. According to Healiva, the acquisition of a qualified fibroblast cell…

RVAC and A*STAR partner to build mRNA capabilities in Singapore

RVAC Medicines and the Agency for Science, Technology and Research (A*STAR) will develop solutions to construct mRNA manufacturing and analytics capabilities in Singapore. RVAC, a messenger RNA (mRNA) technology platform firm headquartered in Singapore, will work with research and development (R&D) agency A*STAR to jointly establish a laboratory. The joint laboratory will be located at A*STAR’S Bioprocessing Technology Institute (BTI) in Singapore and will be used to advance a preclinical production platform, which will enable the generation of raw materials…