whitepaper
Whitepaper: Why extractables and leachables matter
Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
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Outsourcing
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Catalogue: Standard cleanroom POD
G-CON’s standard POD maximises efficiencies in production, qualification and cost and eliminates the complexity of cleanroom construction projects.
whitepaper
Whitepaper: The necessity of E&L qualifications for lyophilised drug products
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
whitepaper
Brochure: G-CON cleanroom POD
G-CON cleanroom PODs. Reliable, flexible prefabricated cleanrooms for the biopharmaceutical industry. On budget and on time.
whitepaper
Article: CCI test method development using headspace gas ingress
Update your blue dye ingress test and generate robust analytical CCI data in all stages of the product life cycle.
webinar
Comparing EMA and Health Canada CTA submission for Phase I trials to US FDA IND application
13 January 2021 | By Altasciences
Watch this webinar on-demand which presents an overview of a foreign health authority’s requirements for gaining approval to conduct an FIH clinical trial by comparing Health Canada and European Medicines Agency (EMA) Clinical Trial Authorisation (CTA) processes to that of the FDA IND submission.
news
CDMO awarded $850,000 contract for development of Acute Cannabinoid Overdose treatment
Under the contract, IRISYS LLC will develop a new, injectable formulation of drinabant that can rapidly and effectively reverse the symptoms of Acute Cannabinoid Overdose (ACO).
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On-demand webinar: Best practices for cleaning and disinfection
This on-demand webinar focuses on the importance of cleaning and disinfection, covering legal requirements and the global guidelines for disinfection in cleanrooms.
whitepaper
Factsheet: Total Organic Carbon (TOC) back to basics
Total Organic Carbon (TOC) analysis is used to comply with compendia water testing requirements. Read this document to learn the basics on TOC.
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New opportunities for the global API market
Active pharmaceutical ingredients (APIs) are primary components in the manufacture of drugs, yet this global market experiences numerous challenges. Regulatory pressure, pricing arbitrages, a shift to digital manufacturing and patents for blockbuster drugs are chief among them, but the COVID-19 pandemic added a further hurdle as governments globally decided to…
whitepaper
Fact sheet: 5 Secrets to a successful cleaning validation program
Here are five ways to ensure a successful and compliant cleaning validation program.
news
COVID-19 is benefiting contract manufacturing services, suggest reports
Reports have found that the COVID-19 pandemic is providing new opportunities for contract and development manufacturing organisations (CDMOs).
whitepaper
Fact sheet: CFS 1200® capsule filling and sealing machine
At Lonza, we have developed our CFS 1200® capsule filling and sealing machine as part of our Lonza Engine™ portfolio. Used with our Capsugel® capsules, pharmacies can automate this process to optimise operations and accuracy. This fact sheet will introduce you to its handling and sealing capabilities, key benefits, performance…
article
Maintaining pharmaceutical operations during a pandemic through innovation and remote technologies
G Balaji and Ravi Kalla explains how Pharma 4.0 can be implemented at a CRO to enable work to continue even during a global pandemic.
news
Pharma M&A activity up 17 percent year-on-year in H1 of 2020
A new report has highlighted that despite the pandemic, pharma M&A activity rose but deal value fell in the first half of 2020.
