Dosage Forms

Experts describe best practices for sterility assurance in parenteral drug manufacturing. This article contains bonus online-exclusive material.

Sound policies are needed to govern the substitution of interchangeable biologics.

A Q&A with Tony Hitchcock, head of manufacturing at Cobra Biologics.

Russell Madsen, group leader of the Parenteral Drug Association (PDA) Filtration Interest Group, discusses technical and regulatory considerations in filtration for parenteral drug manufacturing

Equipment suppliers are helping the pharmaceutical industry move towards adoption of continuous tablet production.

Loss-in-weight feeders provide high accuracy for feeding powders.

Dow Chemical and Bend Research are developing and commercializing new materials for spray-dried dispersions that address technology gaps in manufacturability and delivery.

Matthieu Egloff, product director with ATMI LifeSciences, discusses the need for larger, special reactors that can provide the necessary conditions for the production of fragile cells on a larger scale.

The growth in biologics drugs and vaccines is leading to greater demand for prefilled syringes, which provide greater safety and convenience for healthcare workers and patients.

Roche and BioLamina have entered into a research and development agreement to jointly develop new cell culture systems for various applications, including stem cell research. The collaboration will assess laminin-based in-vitro cell culture matrices that can offer physiological microenvironments for living cells.

Mylan announced that it has signed an agreement to acquire the generic injectables unit Agila Specialties from Strides Arcolab for $1.6 billion in cash.

Companies risk drowning in alphabet soup if the latest three-letter acronym improvement strategy isn't clearly linked to business strategy.

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

Vaccine development is benefiting from manufacturing advances and support for global health.

Growth is seen in outsourcing of insect- and plant-cell-based bioproduction expression systems.

Recent advances in equipment design and operation in spraying, drying, and mixing can improve the tablet-coating process.

The tableting science anti-research (TSAR) project seeks to understand why certain formulations stick to tablet tooling.

A roundtable discussion of the challenges and innovations in tablet splitting featuring Freeman Technology, Accu-Break Pharmaceuticals, and Medelpharm.

An alternative chapter has been added to the European Pharmacopoeia for dosage uniformity.

Custom manufacturers with expertise in highly potent API production discuss the latest issues and technology developments in the field.

Kevin Ott, executive director of the Bio-Process Systems Alliance, discusses the latest trends and issues surrounding single-use technologies and the role of his association.

AAIPharma Services CEO Patrick Walsh talks about the parenterals market and the drivers for his company's recent expansion of its sterile-manufacturing capabilities.

The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended Sanofi's six-in-one pediatric vaccine for marketing authorization.

Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.

Protein Sciences announced that the Biomedical Advanced Research and Development Authority (BARDA) will continue to support the company?s influenza vaccines program.

The share of biologic-based drugs in the global pharmaceutical market is on the rise.

New product reviews for February 2013.

Adopting a seven-step process to maintenance and storage improves tableting quality.

Even in an industry in which all product development is complicated by the intricacies of human biology, orally inhaled products (OIP) stand out as singularly demanding.

GlaxoSmithKline has formed a joint venture with Indian vaccines company Biological E to research and develop a six-in-one combination pediatric vaccine to help protect children in India and other developing countries from certain infectious diseases.