Contents


Chemicals & raw materials 32 Helping the


medicine go down Excipients are often described as inert or inactive, in the context of formulating drugs. But this is only partially true, as while they don’t interact with proteins, enzymes, receptors, nucleic acid or bio- membranes in the same way as an active pharmaceutical ingredient, they can have physical and chemical interactions with an API itself. This can be a positive or a negative, depending on the desired use for a drug. Monica Karpinski speaks to Robert Luxenhofer, professor of soft matter chemistry at the University of Helsinki; Fernando Muzzio, distinguished professor of chemical and biochemical engineering at Rutgers University; and Amal Eli Elkory, professor of pharmaceutics at the University of Sunderland, to find out why physicochemical interactions are important in drug development.


35 The market for fine and speciality chemicals Chemspec


37 Get the right dose SPI Pharma


Manufacturing 38 It's better together


Cell and gene therapies are altering what’s possible in the world of medicine – but the scope of their implementation depends on the scale of manufacturing. It is to this end that organisations looking to make their mark in the field of cell and gene therapies have taken a collaborative approach to figuring out best practices. In an industry where every company has traditionally


38 World Pharmaceutical Frontiers / www.worldpharmaceuticals.net


looked to gain a competitive advantage, Andrea Valentino speaks to Courtney Silverthorn of the Foundation for the National Institutes of Health, and Professor Kelvin Lee at the National Institute for Innovation in Manufacturing Biopharmaceuticals, to learn why teamwork may be the future.


32


41 Cleaning validation helps avoid contamination LAST Technology


43 Contamination control Dycem


Outsourcing


44 Safety and urgency Cell and gene therapies raise more challenges for quality control than traditional biopharmaceuticals, as they are highly specialised and manufactured in small batches. This is especially true in the case of autologous therapies, where a patient’s own cells are used as the basis for a treatment. Jim Banks speaks to Mike Brewer, director of regulatory at Thermo Fisher Scientific and Félix Montero-Julian, healthcare scientific director at bioMérieux to find out how companies that produce cell and gene therapies ensure they qualify as safe and effective, while also getting them to patients as quickly as they can.


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