evolution in biologics drugs need for administration of high viscosities

While all major regulatory agencies have expectations regarding the ability of a pharmaceutical wash process to provide a suitable level of pre-sterilization depyrogenation, the United States (U.S.) Food and Drug Administration’s (FDA) requirements appear to be particularly stringent. 

West Technical Operations

On December 1, 2013, the United States Pharmacopeia (USP) General Chapter &lt;1&gt;&nbsp;Injections<em>,&nbsp;</em>Labeling on Ferrules and Cap Overseals (USP 34-NF 29 November 1, 2010) revised standard will become effective. The revised chapter affects all injectable drug products, human and veterinary, intended for sale in the United States.

Global Communications

<span style="color: #333333;">Technology is becoming a common component to any drug delivery mechanism. With West&rsquo;s ongoing partnership with connected health expert, <a href="/sitecore/service/notfound.aspx?item=web%3a%7b91ADE0E1-ABB4-4B9C-BC44-C84AF2B9D310%7d%40es-ES"><span style="color: #0000ff; text-decoration: underline;">HealthPrize</span></a>, a new course to improve patient outcomes has been charted. By connecting West <a href="/es-es/products/self-injection-platforms"><span style="color: #0000ff; text-decoration: underline;">drug delivery systems</span></a> with the training, education and rewards from the HealthPrize model, we are addressing some of the most fundamental challenges surrounding adherence.</span>

Chris Evans

Vice President, Innovation

Since 25 August 2023, the revised European Union guidelines for Good Manufacturing Practice (EU GMP) Annex 1 has imposed requirements to implement a Contamination Control Strategy (CCS) across the facilities of finished drug product manufacturers, to ensure higher quality and sterility of medicinal products for human and veterinary use.

Gaynor Choo

Sr Specialist, Scientific Affairs, Jurong

<p><em>Component manufacturing process designed with Quality by Design principles meets the high-quality needs of pharmaceutical manufacturers and patients </em></p><p>West has introduced a new line of high-quality components under its NovaPure brand at the PDA Annual Meeting. Through a product development process that incorporates Quality by Design principles, NovaPure components, including serum and lyophilization stoppers and syringe plungers, will help to ensure the safety, efficacy and purity of injectable drug products.</p>

Global Communications