Manufacturing, Drug Products

The new method was developed to isolate tissue-specific EVs from the blood in addition to using a workflow to analyze their diverse multi-omics content.

The first CleanCap analog was launched in 2017, and since then, the capping technology has been incorporated in one of the first commercially approved COVID-19 vaccines.

According to a press release, SGS has doubled its capacity for nitrosamine testing for North American customers.

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.

The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations.

Lonza’s investment in its Stein and Basel facilities in Switzerland aims to expand its overall drug product development and manufacturing services.

USAntibiotics will serve as the sole American-based provider of amoxicillin and amoxil clavulanate.

Syngene’s additions include a new microbial facility and an expanded mammalian facility.

Recro acquires CDMO IRISYS, establishing a bi-coastal presence in the US.

Veraxa and Indivumed will work together to develop colorectal antibody drugs.

Syngene International appoints two US-based executives to senior level positions.

VICO Therapeutics’ drug candidate, VO659, for treating Huntington’s Disease was granted orphan drug designation by FDA.

Kriya Therapeutics completes $100 Million Series B financing to advance its platform for designing, developing, and manufacturing gene therapies.

BioNTech plans to expand its global footprint by establishing its regional headquarters for southeast Asia and a new mRNA manufacturing facility in Singapore.

The expanded agreement will include aseptic fill/finish services at its San Diego, CA facility.

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.

The companies will aim to establish clinical and commercial supply agreements for Plus Therapeutics’ RNL-liposome drug product at the appropriate stage of development.

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

Emergent will use its CDMO services to manufacture drug product batches to support the increased supply of the therapeutic candidate in anticipation of a potential emergency use authorization in the first quarter of 2021.

The expansion will include new suites for the development and clinical manufacturing of drug product intermediates and drug products and cGMP suites for early-phase cGMP manufacture.

Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.

The companies will utilize Avid’s upstream and downstream process development and drug substance manufacturing services in conjunction with Argonaut’s parenteral drug product fill-finish services for the delivery of CGMP parenteral drug products for use in clinical studies.

Aji Bio-Pharma launched Ajility, a flexible platform for manufacturing vaccines and therapies.

Leadership was announced for the US government’s Operation Warp Speed program, which aims to deliver COVID-19 vaccines, therapeutics, and diagnostics.