Dosage Forms

Biotech boom, niche markets, smaller batch sizes and high potency manufacturing are among the key trends shaping the pharmaceutical industry of the 21st century, according to Christian Treitel from Bosch Packaging Technology.

South Africa’s Biovac Institute, which develops and produces vaccines for the country, launched a public-private partnership with Pfizer to enable local manufacturing of Prevenar 13, a vaccine against pneumonia-causing bacteria.

At least 70 patents for Humira will protect the legacy product from biosimilar competitors, according to information presented during the company’s third-quarter earnings call.

Better process development is creating industry benchmarks for bioprocessing.

Delamination of glass packaging is a source of particulates in parenteral drugs, but identifying the root cause allowed the design of an improved manufacturing process for glass vials.

Industry experts share insights on the advances in tablet coating technologies and the potential of continuous coating in solid-dosage manufacturing.

Sartorius Stedim Biotech’s Flexsafe 3D Pre-designed Solutions meet ASTM D4169 Standard Practice requirements and are designed for storage and shipping of biopharmaceutical fluids.

Although shortages, quality, and regulatory challenges remain, improved technologies and new investments suggest that the worst may be over.

Miriam Beyer, European marketing manager, West Pharmaceutical Services, describes causes of recent parenteral drug shortages.

ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.

USP responds to FDA's draft guidance on the naming of biological products.

Catalent’s SMARTag™ technology enables biologic innovators to develop more efficacious antibody drug conjugates. It allows site-specific, programmable drug placement using proprietary cytotoxin-linkers/conjugation chemistry in an efficient and scalable process.

Capsugel has launched its enTRinsic drug-delivery technology platform. Using pharmaceutically approved enteric polymers, the technology offers full enteric protection without the need for functional coatings and enables targeted release of gastric acid- and heat-sensitive active ingredients in the upper gastrointestinal tract. The new technology platform expands Capsugel’s range of modified- and targeted-release solutions and biotherapeutic formulation offering, and can be used for oral delivery of drugs, including vaccines, proteins, and peptides.

According to a third-quarter earnings report, Pfizer’s vaccine business contributed nearly 14% to its total revenue.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

Biovest’s mAbVault provides supply-chain redundancy for antibodies that enables customers to lock in price-per-gram protein production.

A rheometer and powder flow tester can measure how pharmaceutical materials, such as powders from a hopper, flow.

The FDA grants to the Rutgers-led C-SOPS research consortium will support the introduction of continuous manufacturing techniques for pharmaceuticals.

Hovione is investing in specialized formulation capabilities, beginning with the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal, the company announced on Oct. 19, 2015. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

Scottish injectable-drug manufacturer Symbiosis Pharmaceutical Services plans to expand its sterile filling facility.

At CPhI Worldwide 2015, The Dow Chemical Company announced the global commercial availability of AFFINISOL HPMC HME, a new generation of cellulosic polymer for drug solubilization. The polymer is designed for use by pharmaceutical companies looking to enhance the solubilization and inhibit the recrystallization of APIs in hot-melt extrusion (HME) formulations.

Catalent Pharma Solutions won the “Innovation in Process and Formulation Development” category at the annual CPhI Pharma Awards, for its OptiShell softgel technology platform.

The Quad Pulse Package PX dust collector from Camfil Air Pollution Control is a compact unit for processes that produce hazardous dusts in high concentrations, with a cleanable filter system that facilitates continuous manufacturing.

Steris Corporation’s steam sterilizer provides reliable decontamination for high-containment facilities.

Ajinomoto Althea, a biopharmaceutical CDMO, is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates (ADCs), the company announced on Oct. 14, 2015. The new facility is located in close proximity to the company’s existing operations in San Diego, CA.

The new sugars are touted to increase the efficacy of active pharmaceutical ingredients and improve cell culture yield.

Cell Therapy Catapult will provide manufacturing scale-up services to enable Asterias’ future clinical trials and commercial supply for Asterias’ allogeneic dendritic cell immunotherapy, AST-VAC2.

Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.

The Cell History File is designed as a “cell passport” for developers and manufacturers of tissue- and cell-based medicinal products.