Lonza Introduces New Capsules; Spinofrin Secures $4 M for ExpansionBy
The latest from CDMOs, CMOs, and suppliers featuring Lonza, Spinofrin, ChemPartner, and Oxford BioMedica.
Chemicals/Chemical APIs Manufacturing
Spinofrin Secures $4 M for Expanding Industrial Ops
Spinofrin, a Boulogne-Billancourt, France-based company specializing in submicronic particle-size engineering and optimization of active pharmaceutical ingredients (APIs), has secured funding of EUR 3.5 million ($3.9 million) to scale up its industrial operations. Spinofrin specializes in optimizing the kinetics of dissolution and stability of APIs.
Created in 2018, Spinofrin uses a patented spray-flash evaporation technology to produce innovative powders of APIs. The technology was developed within the Nanomaterials Laboratory for Systems under Extreme Stress (NS3E), a joint research unit of the Franco-German Research Institute of Saint-Louis, the French National Center for Scientific Research (CNRS), and the University of Strasbourg. The laboratory is studying the influence of the reduction in particle size and nanostructuring of composites and their performance with regard to reactivity, sensitivity and properties.
Optimizing the size of certain compounds increases their bioavailability with direct applications in the pharmaceutical, cosmetic, food and industrial sectors. The products resulting from the process have a calibrated particle size smaller than one micron and can be pure active agents, coated, or co-crystallized. This continuously operating process is an alternative to traditional grinding or batch atomization techniques. Spinofrin says it has already carried out first conclusive tests for major pharmaceutical and cosmetic groups.
Created within the start-up studio, Technofounders, Spinofrin was awarded the i-Lab prize in 2018 and was selected by Challenge magazine among the 100 French start-ups to invest in 2020.
Daniele Cardoso, former shareholder and President of INFA Group, joins the board of the company. Completing the round of financing were: Dominique Gaillard, president of France Invest and co-founder of Ardian, Laurent Ritter, co-founder of Voodoo, and TF Participations, the investment vehicle of TechnoFounders. Bpifrance, a French investment bank, also supported the company.
ChemPartner Expands Biologics Capabilities
ChemPartner, a CRO/CDMO, has opened a new biomanufacturing facility in Qidong, China outside of Shanghai.
The 67,000-m2-campus includes a laboratory center with a 5,000-m2 animal facility, administration building, and biologics production plant. The biologics production plant will start operation in August 2020. The 13,000-m2 Phase I biologics production plant will accommodate up to eight 2,000-L and three 500-L single-use bioreactors as well as a vial aseptic-filling and freeze-drying line. It also has analytical facilities to support method development and product-release testing.
Oxford Biomedica, VMIC Enter Five-Year Collaboration Agreement
Oxford Biomedica, a developer of cell and gene therapies and a contract manufacturer, has signed a five-year collaboration agreement with the Vaccines Manufacturing and Innovation Centre (VMIC), a not-for-profit organization established to provide the UK vaccine development and advanced manufacturing capability.
This five-year agreement will involve the organizations working collaboratively to enable the manufacture of viral vector-based vaccines to contribute toward an increase in UK domestic capacity for this specialized field of vaccine manufacturing.
Both Oxford Biomedica and VMIC are original members of the Oxford University manufacturing consortium focused on scaling up the GMP manufacture of the adenovirus vector based COVID-19 vaccine candidate, AZD1222, which has entered clinical trials at multiple sites in the UK. AstraZeneca has now taken over global responsibility for the manufacturing, development and distribution for AZD1222 with an initial clinical and commercial supply agreement for multiple batches signed between AstraZeneca and Oxford Biomedica in late May (May 2020).
As part of the collaboration agreement, VMIC will provide manufacturing equipment for Oxford Biomedica to equip two new GMP manufacturing suites within Oxford Biomedica’s new 7,800- m2 commercial manufacturing center, Oxbox, located in Oxford, UK. This will provide additional manufacturing capacity and enable further scale up for AZD1222 from the summer of 2020 as needed to help supply UK and European vaccine demand. The company says these suites could also potentially be utilized for other viral vector vaccine candidates.
As part of the agreement, Oxford Biomedica will provide training and technical assistance to VMIC staff to accelerate the operational readiness and GMP manufacturing capabilities for viral vector vaccine candidates at VMIC’s new manufacturing site located at the Harwell Science and Innovation Campus. The VMIC facility is due to open in mid-2021.
The agreement also provides a framework for a longer-term partnership between Oxford Biomedica and VMIC, whereby Oxford Biomedica could provide its commercial-scale manufacturing capacity to supply other novel viral vector vaccine candidates for the UK population, when needed.
Source: Oxford Biomedica
Formulation Development/Drug-Product Manufacturing
Lonza Introduces HPMC Capsules for Clinical Trials
Lonza has introduced Capsugel DBcaps, an enhanced double-blinded capsules for clinical trials, designed to be used as an over-encapsulation tool during clinical phases to overcome the challenges of blinding products during trials.
The company says Capsugel DBcaps capsules can be used with medical devices, as well as for over-encapsulation of uniquely shaped dosage forms and comparator products, and are designed to offer a faster, more cost-efficient solution for companies who would otherwise have to produce placebo forms identical in shape and size to the candidate product.
Integrity Bio Expands Fill-Finish Line
Integrity Bio, a Thousand Oaks, California-based CDMO, reports the validation of its second fill–finish manufacturing line, which more than doubles the company’s manufacturing capacity.
Integrity Bio specializes in biologics formulation development and drug-product manufacturing and has formulated over 200 biologics, including vaccines, antibodies, proteins, and peptides.
Source: Integrity Bio
LaunchWorks Manufacturing Lab Evolves to LaunchWorks CDMO
LaunchWorks Manufacturing Lab, a life sciences company, is now LaunchWorks CDMO.
The company has recently received its US Food and Drug Administration registered ISO 13485 certification as a CDMO. Integron Global, a packaging solutions provider, acquired Launchworks in 2017 and has since added additional service offerings, including an automation program.
Source: LaunchWorks Manufacturing Lab