Pharmaceutical Technology Editors

CrystecPharma, a pharmaceutical crystal and particle engineering company, has opened a new subsidiary, Nantong Crystec Pharmaceutical R&D Co. Ltd., and research facility in Haimen City, Jiangsu Province, China.

According to a March 31, 2021 press release, the R&D center was established following an invitation to participate in the Yangtze Delta Advanced Drug Development platform—an initiative jointly funded by the Shanghai Institute of Materia Medica (SIMM), Chinese Academy of Sciences, and the Haimen government. The platform is aimed at accelerating pharmaceutical product innovation underpinned by advanced pharmaceutical excipients and drug delivery technologies. Crystec’s proprietary supercritical fluid technology, mSAS, will play a role in enabling the development of new therapeutics, creation of value-added medicines, and in the simplification of formulations and manufacturing processes.

“We are delighted to open our new facility in Haimen, a project credited to the collaborative efforts of SIMM, Chinese Academy of Sciences, and the Haimen government,” said Qun Shao, Crystec’s chief operations officer, in the press release. “This cutting-edge research facility will enhance our capacity to support clients across China and the rest of the world, and will provide opportunities to achieve rapid transition from proof of concept studies to delivering clinical material for human trials in China.”

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CrystecPharma has opened a new subsidiary, Nantong Crystec Pharmaceutical R&D Co. Ltd., and research facility in Haimen City, Jiangsu Province, China.

CrystecPharma Opens New Subsidiary in China

Sterling Pharma Solutions has announced its acquisition of ADC Biotechnology, a bioconjugation development services business specializing in antibody drug conjugates (ADCs), in an April 6, 2021 press release. The acquisition follows the strategic investment by contract development and manufacturing organization (CDMO), Sterling, in December 2020.

Through the acquisition, the ADC Bio facility, which is based in North Wales in the United Kingdom, will be rebranded and become part of the Sterling Pharma Solutions international network. Combining Sterling’s experience in current good manufacturing practice (CGMP) manufacturing, quality processes, and compliance, with the expertise of ADC Bio, the companies are aiming to establish a center of excellence for bioconjugation and ADC development and manufacturing services.

Financial investment is being made to support to growth of the ADC capabilities, including expansion and development of the existing bioconjugation technical services team and analytical services team (particularly in the CGMP area). Additionally, the companies plan to create CGMP bioconjugation/ADC manufacturing at the North Wales facility in 2022.

“We are delighted to confirm the acquisition of the ADC Bio business, this investment provides us with the opportunity to offer a wider portfolio of services to our customers in the fast-growing ADC and bioconjugation market, as well as providing additional services to existing ADC Bio customers,” said Kevin Cook, CEO at Sterling Pharma Solutions, in the press release. “Integrating our HPAPI [highly potent API] capabilities with the expertise already found at Deeside means that we will also be able to offer the development and manufacture of toxin linkers. This is an exciting time for both businesses as we embark on a period of growth and diversification to ensure we always stay ahead of the next innovation. I’d like to welcome all ADC Bio employees to the Sterling family.”

Alan Raymond, executive chairman of ADC Bio, added in the press release, “This is fantastic news for our employees and our customers; targeted investment in both people and processes will allow the team to continue supporting important advances in drug development with additional services, and importantly with the additional support and experience from the Sterling team.

Sterling Pharma Solutions has acquired ADC Biotechnology, a bioconjugation development services business specializing in antibody drug conjugates.

Sterling Pharma Solutions Confirms ADC Bio Acquisition

Berkeley Lights, a US-based digital cell biology company, announced on April 5, 2021 that it has launched Opto Assure, a series of assays that provide yield and product quality data at an earlier stage in cell-line development.

According to a company press release, the first series supports direct detection of product aggregates for a faster ramp toward volume production by evaluating biotherapeutic protein quality sooner in the antibody therapeutic development process, allowing for customers to rapidly choose clonal cell lines with promising manufacturability profiles.

“We’re excited to empower manufacturers of complex therapeutics, such as bispecifics, to develop better production cell lines faster. As we build out the Opto Assure series, customers can look forward to added capabilities that further reduce resources spent on preventing product failures downstream and ensure a more efficient process,” said John Proctor, PhD, senior vice-president of Antibody Therapeutics at Berkeley Lights, in the press release.

The company has introduced Opto Assure, a series of assays that provide yield and product quality data at an earlier stage in cell-line development.

Berkeley Lights Launches Assay Series for Early Cell-Line Development Yield and Product Quality

Catalent announced on April 6, 2021 that it has expanded its strategic collaboration with Moderna by dedicating a new high-speed vial-filling line at its biologics facility in Bloomington, IN, for the manufacture of Moderna’s COVID-19 messenger RNA (mRNA)vaccine and other investigational programs in Moderna’s pipeline.

Under the terms of the expanded agreement, Catalent will provide Moderna with the filling line until June 2023 along with inspection, labeling, cartoning, and final packaging for the potential pipeline programs, Catalent said in a company press release.

The companies’ initial agreement was announced in 

 and involved Catalent providing aseptic vial filling and packaging from its Bloomington site to support production of an initial 100 million doses of Moderna’s vaccine.

“We appreciate this expanded collaboration with Catalent and the dedication of their team,” said Juan Andres, Moderna’s chief technical operations and quality officer, in the press release. “This additional fill/finish capacity will be important for not only our COVID-19 vaccine, but also potentially for other programs in our clinical development pipeline.”

“Catalent’s partnership with Moderna began in 2016, when we had only glimpsed the potential applications of mRNA and could not have guessed how pivotal mRNA would become in the fight against COVID-19,” added Alessandro Maselli, Catalent’s president and chief operating officer, in the press release. “We are proud to announce this extension of our companies’ strategic collaboration, and we look forward to further demonstrating our commercial manufacturing expertise as we help supply more vaccine doses.”

Under the terms of the expanded agreement, Catalent will provide Moderna with a new high-speed vial filling line until June 2023 along with inspection, labeling, cartoning, and final packaging for potential pipeline programs.

Catalent Expands COVID-19 Vaccine Fill/Finish Collaboration with Moderna

Rokote Laboratories Finland, an academic spin-out, announced on March 8, 2021 that it is working to develop a nasal spray vaccine against COVID-19 based on research from the University of Helsinki and the University of Eastern Finland.

The vaccine uses gene transfer technology developed by Academy Professor Seppo Ylä-Herttuala’s research group at the University of Eastern Finland, the University of Helsinki said in a company press release. The vaccine utilizes an adenovirus carrier that contains a cloned DNA strand, which causes nasopharyngeal cells to create the virus protein, which then produces a response to the vaccine. The vaccine has shown positive results in animal studies and will undergo human testing in a few months. 

“Vaccines injected intramuscularly produce IgG [immunoglobulin G] antibodies in the bloodstream, but nasal vaccines also produce an IgA response that protects mucous membranes,” said Ylä-Herttuala in the press release. “We assume that this can also prevent those who have received the vaccine from transmitting the virus.”

“Even if we were able to vaccinate the entire population, at least people in medical risk groups will still need new vaccines against new variants in the upcoming years. The vaccines currently in use provide a clearly lower protection against the South African variant, which will likely be the dominant virus in the next wave. Our vaccine already takes into account the most important variants [i.e., the South African, Brazilian, and the UK one]. There will certainly be a demand for this type of vaccine,” added Professor of Virology Kalle Saksela from the University of Helsinki, in the press release.

The company is currently negotiating funding toward further development of the vaccine for clinical trials.

Rokote Laboratories Finland, an academic spin-out located in Finland, is working to develop a nasal spray vaccine against COVID-19 based on research from the University of Helsinki and the University of Eastern Finland.

Academic Lab to Develop a Nasal Spray Vaccine for COVID-19

LabConnect, a US-based provider of laboratory and support services for the biopharmaceutical industry, has expanded its facility in Johnson City, TN.

The company, which is known for its customized clinical trial collection kits, plans to add 20,000 ft.2 to the site, tripling its clinical trial kit building capacity and further meeting the demand for cell and gene therapies, immuno-oncology, and other advanced therapeutics services, LabConnect said in a March 16, 2021 press release.

“LabConnect’s expansion is a direct result of tremendous client response to our differentiated services and intense focus on quality and customer satisfaction,” said Tom Sellig, LabConnect’s CEO, in the press release. “The new facility, which will be operational in June, is being developed with funding from a continued partnership with the State of Tennessee. This new expansion comes after the recent expansion of LabConnect’s biorepository and sample storage facility completed in July of 2020.”

The company plans to add 20,000 ft.2 to the site, tripling its clinical trial kit building capacity and further meeting the demand for cell and gene therapies, immuno-oncology, and other advanced therapeutics services. 