INDUSTRY NEWS
Pharmatek Scales Up Spray Drying Capacity
Pharmatek, a contract development and manufacturing organization supporting the pharmaceutical industry, has made a substantial investment into its spray drying capabilities. The company has purchased a second GEA Niro Mobile Minor™, in addition to a ProCepT™ 4M8-Trix™, and a GEA Niro SD Micro™ for the development and GMP manufacture of amorphous spray dried dispersions (SDD).
The purchases complement existing spray drying equipment, including a GEA Niro Mobile Minor and a Buchi B-290. Pharmatek has seen rising demand in SDD across the industry and received specific client requests to increase spray dry capacity.
"Expanding our SDD capacity is driven by significant client demand and is part of Pharmatek's continuing efforts to provide a comprehensive range of bioavailability enhancement solutions for our clients," said Tim Scott, president of Pharmatek. "We are committed to adding new technologies and increasing capacity in development areas that our clients care about."
Pharmatek offers formulation development, process scale-up and GMP manufacturing services for small molecules and peptides. Spray drying is part of the Company's comprehensive amorphous dispersion drug development capabilities that include physical characterization, preformulation testing, analytical development, formulation development and GMP manufacturing of finished dosage forms.
Spray drying is a key component of the Company's solubility enhancement toolkit and platform screening program. The Company's robust suite of technologies includes micronization, spray drying, hot-melt complexation, and liquid-filled-capsule development. Utilizing a data-driven, agnostic approach, Pharmatek screens multiple technologies to determine the best path forward for a given compound and client.
SGS Introduces New Comprehensive Drug Compatibility Study Testing at Expanded Shanghai Facility
SGS has introduced comprehensive drug compatibility study testing at its Shanghai laboratory in China. This new service, for the analysis of potential extractable and leachable contamination within pharmaceutical products, harmonizes services offered in this field across SGS’s global network of laboratories.
China’s Center for Drug Evaluation (CDE) made drug compatibility studies mandatory for all New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) in 2014. SGS’s investment in these services comes after a multi-stage expansion of its laboratory in Shanghai, which was completed in 2015. It includes the installation and validation of new quadrupole time-of-flight (Q-TOF), liquid chromatography-diode array-mass spectrometry
(LC-DAD-MS) and gas chromatography–mass spectrometry (GC- MS) instruments.
“We have seen an increased demand for these services since the regulations have been tightened, and we have been working with regulatory bodies and industry associations to help define and establish definitive testing guidelines in this area going forward,” commented Andy Yi, General Manager, SGS Life Sciences, Shanghai. “With this investment, SGS has been able to build on its strong reputation to attract new customers, as well as increase business with pharmaceutical R&D teams looking to engage with experts earlier in the process to ensure compliance.”
SGS has been providing extractable and leachable testing services from its Shanghai facility to local clients, and international clients with a presence in China since the facility opened in 2006. Expansion of the facility commenced in 2014 and initially included increased capabilities in cGMP chemistry and biotechnology testing laboratories. The microbiology laboratory was expanded subsequently, increasing the total floor space to 3,200 square meters.
Emergent BioSolutions Receives BARDA Task Order Valued at Up to $21.9M to Develop and Manufacture a Zika Vaccine
Emergent BioSolutions has announced that its Center for Innovation in Advanced Developmentand Manufacturing (CIADM) has received a task order from the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $21.9 million to develop and manufacture three cGMP lots of a Zika vaccine for use in a Phase 1 clinical trial. Using a base vaccine candidate provided by BARDA, the company will conduct technology transfer of process materials and information, process and analytical method development, execute small-scale production runs, and perform cGMP cell banking leading to cGMP manufacture of bulk drug substance and final drug product. The task order consists of a 30-month base valued at $17.9 million and includes options that, if executed, will bring the total value to up to $21.9 million.
“Emergent is pleased to partner with BARDA to address the emerging public health threat in Zika,” said Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions. “We look forward to executing on this task order and working collaboratively with the government in its efforts to help contain this epidemic.”
This is the first Zika-related BARDA Task Order awarded to Emergent under the CIADM program. In 2012, Emergent was designated by the U.S. Department of Health and Human Services (HHS) as a CIADM, which allows the company to contract with the U.S. government through task order requests for requirements such as operational readiness, development and manufacturing of CBRN products, warm base maintenance, surge manufacturing, and workforce development.
This Task Order Number HHSO10033003T under contract HHSO100201200004I is funded by BARDA, within the Office of the Assistant Secretary for Preparedness and Response in HHS.
Pharmaceutical Outsourcing | 46 | July/August 2016
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