Manufacturing

The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

The companies collaborate to develop and commercialize ARV-471, an investigational oral PROTAC (proteolysis targeting chimeras) estrogen receptor protein degrader.

Summa Equity has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider.

Catalent Biologics has launched its new cell line expression technology, GPEx Lightning, which aims to shorten drug substance development timelines by up to three months.

Catalent commences the first phase of a $100-million expansion program Anagni site to increase its manufacturing capabilities for biologics drug substance.

Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic.

BioNTech will acquire a TCR cell therapy R&D platform as well as a manufacturing facility in Gaithersburg, Md., from Kite, a Gilead company.

Nkarta will establish a new combined scalable NK cell therapy manufacturing facility and corporate headquarters in South San Francisco, Calif.

Cellares has entered into a strategic relationship with Poseida Therapeutics to advance a closed, automated, and scalable cell therapy manufacturing system.

Pall has secured a manufacturing contract with Exothera for the suspension-based manufacture of gene therapies and viral vector-based vaccines.

The companies work to develop and supply advanced cell models that better reflect an in-vivo environment to improve drug discovery accuracy and efficiency.

Manufacturers seek more sustainable options for temperature-controlled packaging.

Modeling the manufacturing process benefits both development and operations.

The GMP facility is designed to maximize bioprocessing efficiency of newborn stem cells and manufacturing at scale.

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

MTBVAC has the potential to be used as an alternative to BCG vaccination in infants and for prevention of TB disease in adolescents and adults.

ImmunityBio will proceed with a Phase I/II/III trial in South Africa of their dual-antigen T-cell vaccine as a boost in participants who were previously vaccinated against COVID-19.

The US federal government awarded new funding to the National Institute for Innovation in Manufacturing Biopharmaceuticals, including funding under the American Rescue Plan that will be used to advance vaccine manufacturing.

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

GEA’s plug-and-produce skids are designed for multi-product pharmaceutical and biopharmaceutical separation.

NewAge Industries is adding cleanrooms at its Pennsylvania headquarters.

UltraBurst has a high disintegration speed, which is for all market segments, from prescriptions to nutraceuticals.

Purisys is now certified for ISO 17025 for testing and calibration laboratories and ISO 17034 for reference material producers

The F30i double rotary tablet press from Fette Compacting is the second of its new i Series.

Sparx Therapeutics will build its first commercial manufacturing facility in Yangzhou, China, for antibody drug production.

Univercells Technologies and VectorBuilder to produce custom viral vectors for cell and gene therapies as well as vaccine applications.

A new media panel, gene kit, and advanced resins that are now in Thermo Fisher Scientific’s gene therapy portfolio aim to reduce manufacturing costs and increase gene therapy viability.

Novasep and Exelixis have signed a manufacturing services agreement for the CGMP clinical manufacturing of a next-generation ADC candidate.

Recipharm has signed a memorandum of understanding (MOU) with His Majesty the King of Morocco, the Moroccan government, and a consortium of leading banks from the country, for fill/finish capacity in the country.

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.