Pharmaceutical Technology Editors

PPD, a contract research organization, has opened its new multipurpose laboratory in Suzhou, China, to support Western and China-based pharmaceutical and biotech companies managing China research studies. The 67,000-ft2 facility, located in the Suzhou New District, Jiangsu Province, offers bioanalytical, biomarker, and vaccine laboratory services to support trials across all phases of pharmaceutical development.

The bioanalytical lab in Suzhou includes services for small molecules, biologics, and cell and gene therapies and encompasses multiple technology platforms across a wide range of applications, including ligand-binding immunochemistry, liquid chromatography tandem mass spectrometry (LC–MS/MS), polymerase chain reaction (PCR), and flow cytometry. The lab also specializes in the development and validation of fully compliant robust custom assays for pharmacokinetic/pharmacodynamic (PK/PD) analyses and immunogenicity assessments in both preclinical and clinical studies, PPD said in a May 24, 2021 press release.

The biomarker lab offers a range of services applicable across multiple regulatory compliance environments and fit-for-purpose applications. Analysis can be performed with molecular testing, flow cytometry, ligand binding, and LC–MS/MS to support both preclinical and clinical studies. In addition, an alliance with NeoGenomics Laboratories enhances PPD’s internal capabilities. NeoGenomics operates an oncology-focused clinical trials testing lab in the same building as the PPD Laboratories’ central lab in Singapore. The company has established a similar arrangement with PPD for PPD’s new Suzhou facility.

Meanwhile, the vaccine sciences lab provides a full range of testing services specifically designed for vaccine development trials. This lab employs immunoassays, cell-based assays, and multiplexed functional assays for vaccine efficacy. The lab also uses molecular assays for infectious disease monitoring. The lab’s services range from technology assessment and method development to immunogenicity and concomitant studies.

With this expansion at Suzhou, PPD plans to staff approximately 300 highly skilled professional positions over the next three years. The new lab supplements the company’s existing Shanghai central lab, established in 2015. PPD also plans to add central lab services in Suzhou in 2022 to augment the current capabilities in Shanghai and Singapore.

“With our new state-of-the-art operations, the latest instrumentation and high-throughput automation, we are further equipped to provide high-quality results and data for our customers,” said Christopher Fikry, MD, executive vice-president of PPD Laboratories, in the company press release. “We can now offer an in-country lab facility for clinical studies in China that provides the same capabilities that are available for studies at our other locations around the world. Through scientific excellence and consistent, high-quality delivery of critical data, we will help expedite the drug development process for customers who are either based or doing business in China.”

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PPD has opened its new multipurpose clinical research laboratory in Suzhou, China, which offers bioanalytical, biomarker, and vaccine sciences services for China and the global market.

PPD Opens Multipurpose Clinical Research Laboratory in China

Sphere Fluidics has enhanced the capabilities and performance of its Cyto-Mine System, an automated platform that combines single cell screening, sorting, dispensing, imaging, and clone verification.

The new design improves system performance, reliability, and stability, while an update to the software provides a better user experience, reduces user-instrument interaction, and allows for more robust data analysis, Sphere Fluidics said in a May 17, 2021 company press release. The updated instrument also works to simplify antibody discovery, cell-line development, cell therapy, and synthetic biology workflows.

“The new design is the culmination of 18 months' hard work by our R&D team. Due to the deployment of these latest improvements, researchers are now able to perform even faster selective screening of single cells to find rare lead candidates,” said Marian Rehak, vice-president of Research and Development at Sphere Fluidics, in the press release. “Although, principally designed for antibody discovery and cell line development, the platform is very flexible and has now been demonstrated to be useful in a wide variety of application areas.”

“The new Cyto-Mine design not only unlocks increased functionality for scientists but is also faster to manufacture, commission, and service,” added Rob Treanor, operations director at Sphere Fluidics, in the press release. “A new user can learn how to run our user-friendly software within a single working day. We are helping our users to simplify their workflows with the added operational benefit of enhancing our service and support capacity.”

The new design improves system performance, reliability, and stability, while an update to the software provides a better user experience, reduces user-instrument interaction, and allows for more robust data analysis.

Sphere Fluidics Enhances Capabilities of its Cyto-Mine System

Samsung Biologics announced on May 31, 2021 that it plans to add messenger RNA (mRNA) vaccine drug substance manufacturing capabilities to its facility in Songdo, South Korea.

Expected to be completed by 2022, the new addition is part of the company’s long-term strategy to become a fully integrated global biopharmaceutical company, Samsung Biologics said in a company press release.

“We are constantly assessing various ways that we can expand and persify our current business portfolio to better serve the market,” said John Rim, CEO of Samsung Biologics, in the press release. “We are committed to helping our clients provide quality treatments and vaccines to all those in need around the world, especially in difficult times like this, and with this extended capability, we hope to support our partners in bringing novel mRNA vaccines and therapeutics to market at a faster pace.”

Expected to be completed by 2022, the new addition is part of the Samsung Biologics’ long-term strategy to become a fully integrated global biopharmaceutical company.

Samsung Biologics to Add mRNA Capabilities to South Korea Facility 

FDA announced on May 26, 2021 that it has issued an emergency use authorization (EUA) for sotrovimab, an investigational monoclonal antibody (mAb) therapy, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive viral testing results and who are at high risk for progression to severe COVID-19. 

The EUA was issued to GlaxoSmithKline based on an interim analysis from a phase I/II/III randomized, double-blind, placebo-controlled clinical trial with a primary endpoint of COVID-19 progression through day 29, FDA said in a company press release. Of the 583 participants, 291 received sotrovimab and 292 received a placebo within five days of onset of COVID-19 symptoms. Hospitalization or death occurred in 21 patients who received the placebo compared with three patients treated with sotrovimab, demonstrating an 85% reduction in hospitalizations/deaths in the mAb-treated population.

“With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” said Patrizia Cavazzoni, MD, director of FDA’s Center for Drug Evaluation and Research, in the press release. “It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States.”

Currently, sotrovimab is not approved for patients who are hospitalized or require oxygen therapy due to COVID-19.

FDA has issued an emergency use authorization for sotrovimab, an investigational monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19. 

FDA Issues EUA for mAb Therapy for the Treatment of COVID-19

Further advice on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca) has been provided by the European Medicines Agency (EMA).

According to the updated recommendations, EMA’s Committee for Medicinal Products for Human Use has specified that healthcare professionals should use Vaxzevria in people who have had blood clots with low blood platelets after receiving the vaccine, check for signs of blood clots in people with low blood platelets within three weeks of being vaccinated, check for signs of low blood platelets in any person that has had blood clots within three weeks of being vaccinated, and ensure that patients who have blood clots with low blood platelets after being vaccinated receive specialist care.

Although the incidences of blood clots with low blood platelets after vaccination remains very rare, EMA is continuing to issue advise to the public on symptoms to be aware of, in cases where prompt medical treatment may be required. All updated recommendations are available in the vaccine’s product information.

EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).

Further Advice on Vaxzevria Issued in Europe

The European Medicines Agency (EMA) has issued a recommendation to grant the European Union (EU) marketing authorization application for Bylvay (odevixibat) as a treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged six months and older.

PFIC is a rare liver disease that is life-threatening, with approximately only half of the children suffering from the disease surviving past the age of 10 years old. As a result of the limited treatment options available for PFIC patients, there is a high unmet need for therapies to treat this disease.

EMA’s Committee for Medicinal Products for Human Use (CHMP) has based its positive recommendation on the results of a Phase III study, in which the efficacy and safety of Bylvay in children with PFIC were assessed. The clinical trial results demonstrated that the therapy, which selectively inhibits the ileal bile acid transporter, was effective at significantly reducing the serum bile acids and, in patients treated with odevixibat, a significant reduction in pruritus was seen.

The positive results demonstrated with Bylvay were maintained in an ongoing, long-term open label; however, more data are required to confirm if the therapy delays disease progression and the requirement for liver transplantation. Therefore, CHMP has requested a registry-based efficacy study as a follow-up.

Furthermore, as a result of the rarity of PFIC, CHMP has concurred that comprehensive data on the efficacy of the therapy under normal conditions of use will not be plausible. As such, CHMP has recommended that the marketing authorization be granted under exceptional circumstances.

EMA has recommended EU marketing authorization for Bylvay (odevixibat) as a treatment of progressive familial intrahepatic cholestasis (PFIC).