Formulation and Drug Delivery

The agency has published seven guidance documents directed at the development and manufacture of gene therapies.

The facility will produce parenteral products and delivery devices and is set to create 460 new jobs.

The FDA guidance provides an explanation of changes to user fees under the Biosimilar User Fee Amendments of 2017 under Title IV of the FDA Reauthorization Act of 2017.

GE Healthcare Life Sciences’ new facility for cell and gene processing supplies will be open in 2022.

A development and manufacturing partnership with Thermo will allow Civica to expand its internal pipeline of medications for use in emergency and critical care in the United States, further preventing the risk of drug shortages.

By halting the withdrawal process, Civica could further its goal to stabilize the supply of generic medications and prevent drug shortages in the United States.

The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.

FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.

Achieving effective manufacturing processes and sufficient capacity remains a top priority across a diversified biologic drug pipeline.

Generic pharmaceutical company, Hikma Pharmaceuticals, and biopharmaceutical company, Arecor, have entered into an exclusive agreement for the development and commercialization of a ready-to-use injectable medicine.

Under the agreement, Almirall will leverage WuXi Biologics’ proprietary WuXiBody platform to develop bispecific antibodies for dermatological diseases.

The joint venture will develop next-generation cell and gene therapies incorporating Affimer proteins.

Roche will apply ProBioGen’s proprietary GlymaxX technology to boost the antibody-dependent cellular cytotoxicity activity of antibodies.

Through the acquisition, Johnson & Johnson will gain access to Taris’ lead clinical-stage product, TAR-200.

Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies.

The aim of this study was to prepare taste-masked drug-resin complex using ion exchange resin Kyron T-134.

As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.

PTE looks ahead to 2020’s edition of Pharmapack-the pharma industry’s dedicated packaging and drug delivery event.

Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.

Sanofi Pasteur will expand clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine at its site in Pennsylvania.

The new Technology Excellence Center, located in Boston, MA, will further the company’s presence in the United States biopharma drug development landscape.

Catalent and Ethicann Pharmaceuticals have announced a partnership aimed at developing a new combination pharmaceutical-grade CBD and THC product to treat MS spasticity using Catalent’s orally disintegrating tablet technology.

CPI has partnered with ImmunoBiology (ImmBio) for the development of a heat-stabilized formulation of a mutli-antigen vaccine candidate against Pneumococcal diseases.

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.

Visualization using virtual and mixed reality can aid with biopharma manufacturing facility design and training.