PHARMACEUTICAL MANUFACTURING

CONTRACT PHARMA MANUFACTURING WHITE PAPERS & ARTICLES

  • 5 ADC Manufacturing Challenges You Need To Know

    The unique targeting capabilities and promising clinical trial results of antibody-drug conjugates (ADCs) have made them an exciting and promising treatment in the fight against cancer. According to recent analysis, experts anticipate the ADC market to be worth $10 billion annually by 2025. However, despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Below are five key areas where pharmaceutical manufacturers may face the biggest uphill battles.

  • The Right Biomanufacturing Partner Can Mitigate Forecasting Risks

    While forecasts can never be 100% accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible.

  • Operational Excellence In a Flexible Manufacturing Environment

    By thinking outside of the box, CDMOs can create a flexible and scalable business model that offers a level of assurance in the face of forecast variability.

  • How To Live With Uncertain Pharma Demand Forecasts

    The consequences of inaccurate demand forecasting can be reputational damage, market share loss, lost days of production, destruction of inventory, and layoffs.

  • Continuous Flow Chemistry (Processing) for Intermediates and APIs

    Many contract manufacturing organizations (CMOs) offer continuous flow chemistry, but few have the technical capabilities to help customers take full advantage. The potential benefits for active pharmaceutical ingredient (API) development and manufacturing include higher selectivity, the ability to use novel chemistries, improved scalability, and enhanced safety.

  • Understanding Ion Resin Technology Ion exchange resins have been in use for many years in pharmaceutical formulations. Their uses have ranged from simple excipients for tablet disintegration to the rate controlling function in extended release formulations. However, efficient drug utilization has been less than ideal historically in the formation of drug-resin complexes to be used in pharmaceutical products.
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CONTRACT PHARMA MANUFACTURING APPLICATIONS & STUDIES

  • Paediatric Drug Product Development Through To Commercialization
    Paediatric Drug Product Development Through To Commercialization

    Almac has developed a flexible paediatric dosage form consisting of minitablets filled into stickpacks using a robust manufacturing and filling process suitable for routine commercial manufacture.

  • Accelerated Fill/Finish CGMP Campaign For A Biologic Drug Product Program
    Accelerated Fill/Finish CGMP Campaign For A Biologic Drug Product Program

    Manufacturing of biological and small molecule drug products is on the rise, and more often than not, generation of stability data and getting product released for clinical trials are on the critical path to approval. Emergent Camden not only understands that, but delivers quality product in timelines significantly shorter than other contract manufacturers.

  • Case Study: Controlled Drug Handling A midsize pharmaceutical company came to Aptuit to work through the complexities of exporting a controlled substance manufactured in the United States and an EU-sourced comparator for inclusion in a clinical trial across more than 12 EU participating countries. Aptuit’s client was dealing with an Investigative Medicinal Product (IMP) manufactured in the United States and an EU-sourced comparator. By Aptuit, Inc.
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CONTRACT PHARMA MANUFACTURING SERVICES

Pharmaceutical Contract Packaging: Quality And Technologies Pharmaceutical Contract Packaging: Quality And Technologies

Our cutting-edge technology and impeccable standards ensure that our customers receive products that meet their exact needs.

Fill/Finish Product Testing & Stability Testing Fill/Finish Product Testing & Stability Testing

Emergent BioSolutions typically performs the following testing on products.

Drug Product CGMP Lyophilization Manufacturing Services Drug Product CGMP Lyophilization Manufacturing Services

Emergent BioSolutions currently fills a number of lyophilized products in its two 240 ft2 lyophilizers.

Aseptic Fill/Finish Commerical Contract Manufacturing Aseptic Fill/Finish Commerical Contract Manufacturing

Emergent BioSolutions currently fills over 20 commercial products with several more products pending approval. Using Emergent BioSolutions for commercial manufacturing has a number of advantages.

Clinical Contract Manufacturing Clinical Contract Manufacturing

Emergent BioSolutions performs clinical manufacturing for all regulatory phases. Contracting with Emergent BioSolutions or clinical manufacturing has a number of advantages.

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 PHARMACEUTICAL MANUFACTURING EVENTS

Root Cause Analysis Post ICH GCP E6 (R2): Beyond Fishbones and 5 Whys! March 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD) – An Overview March 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Informed Consent (eIC): How The New FDA/OHRP Final Guidance Affects You April 4, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made April 5, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding The New NIH/HHS Final Rule On Clinical Trial Reporting – Tips For Compliance Success April 6, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!