Sterling Pharma, AGC Biologics, Rondo-Pak Expand

The latest from CDMOs, CMOs, and suppliers featuring Sterling Pharma Solutions, AGC Biologics, Rondo-Pak, Samsung Biologics, LabVantage Solutions, Exothera, and Genezen.

Chemicals/Chemical API manufacturing

Sterling Initiates Continuous Flow Chemistry Center of Excellence
Sterling Pharma Solutions, a Dudley, UK-based CDMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates, has completed the initial phase of investment at its site in Dudley to create the company’s center of excellence for research into commercial applications of continuous flow chemistry.

The announcement of the investment follows the appointment of Professor Ian R. Baxendale at Durham University in the UK to lead a team of chemists and engineers to specialize in this area. The team will focus on processes to kilogram scale initially, with a view to future industrialization.

Source: Sterling Pharma Solutions

Biologics Manufacturing

AGC Biologics Expands pDNA, mRNA Mfg Capacity
AGC Biologics, a contract biologics manufacturer, has announced plans to expand the company’s Heidelberg, Germany facility to increase manufacturing capacities for plasmid-DNA (pDNA) and messenger RNA (mRNA) projects.

AGC Biologics is adding to its current 100-L and 1,000-L manufacturing capacities by adding an additional manufacturing line. The expansion includes a new cleanroom for mRNA development and manufacturing, a new process development lab for microbial protein and cell-and gene-therapy projects, and additional warehouse capacity. The facility’s new capabilities will be fully operational in 2023.

Last month (August 2021), the company broke ground on a new biologics manufacturing facility at its site in Copenhagen to more than double the company’s single-use bioreactor mammalian cell-culture capacity at the site. The expansion is slated to begin operations in 2023.

Also, in August 2021, AGC Biologics acquired a commercial manufacturing facility in Longmont, Colorado, previously owned by Novartis Gene Therapies. The facility adds 622,000 square feet of operations and office space primarily planned for cell-and gene-therapy activities. The facility is expected to begin full-scale operations by the fourth quarter of 2021 and is near AGC Biologics’ large-scale stainless-steel mammalian biomanufacturing facility in Boulder, Colorado.

Source: AGC Biologics

Exothera, GeneQuine Partner for Gene Therapy
GeneQuine Biotherapeutics, a Hamburg, Germany-based gene-therapy company, has contracted with Exothera, a Brussels, Belgium-based viral vector CDMO launched by Univercells, a technology company specializing in bioprocessing, to conduct a feasibility study for the development of a large-scale manufacturing process for GeneQuine’s osteoarthritis gene-therapy product candidate, GQ-303 and other product candidates.

Source: GeneQuine and Exothera

Samsung Biologics Joins Carbon Neutral Initiative
Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, has signed a memorandum of understanding to participate in the Frontier 1.5D initiative to develop a climate risk-management model as part of a 2050 carbon neutral strategy.

The Frontier 1.5D project is a global collaborative effort to limit temperature rise to 1.5 °C above pre-industrial levels where local business leaders have joined the British Embassy, Ewha Womans University in Seoul, South Korea, and Financial Supervisory Service, South Korea’s financial regulator, to collectively aim for to be carbon net-zero. Frontier 1.5D is expected to address uncertainties associated with climate change by analyzing the financial impact of climate-change and climate-response policies such as greenhouse gas reductions.

Source: Samsung Biologics

Genezen Appoints New CEO
Genezen a cell- and gene-therapy CDMO, has appointed Ray Kaczmarek, formerly Senior Vice President of GMP Operations at the CDMO, TriLink Biotechnologies, as CEO.

He has served in several other leadership roles, including as President at Nitto Avecia Pharma Services, a Milford, Massachusetts-based provider of nucleic acid manufacturing and development services, and as Vice President Manufacturing and Supply Chain Operations for Pacira Biosciences, a Parsippany, New Jersey-based provider of non-opioid pain management and regenerative health services.

Source: Genezen


Rondo-Pak Expands Offset Printing Capacity
Rondo-Pak, a provider of folding cartons and printed components for the pharmaceutical, medical device, and consumer industries, has upgraded its equipment line at its primary facility in Camden, New Jersey with the addition of a new 10-color Heidelberg Speedmaster XL 106 Perfector.

A $5.5-million-dollar investment, the new press will increase the company’s offset printing capacity by over 20% and is capable of production speeds of 18,000 sheets per hour. It will be operational in the fourth quarter of 2021.

Source: Rondo-Pak


LabVantage Solutions Launches New Enterprise Software
LabVantage Solutions, a provider of laboratory informatics products and services, including laboratory information management systems, has launched the LabVantage Enterprise SaaS, a new service that incorporates LabVantage’s software-as-a-service (SaaS) option with software configurability and interfacing for laboratories to use with the SaaS laboratory information management systems (LIMS).

LabVantage Enterprise SaaS adds full configurability and interfacing support for external software systems.

Source: LabVantage Solutions