PHARMACEUTICAL MANUFACTURING

CONTRACT PHARMA MANUFACTURING WHITE PAPERS & ARTICLES

  • Cost Savings And Speed: The Untapped Value Of A Single-Source Solution

    Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.

  • Solving the OOS Problem with Continuous Manufacturing

    With continuous manufacturing, it is possible to monitor product quality continuously, and make adjustments in real time to keep the product in spec. And when it isn’t, as will sometimes (albeit rarely) happen, the manufacturer can step in more quickly than ever before to limit the volume of OOS product — saving time, money, and staying ever closer to the ideal quality standard.

  • Avoid the Do-Over: Why Early Investment in a Scalable Manufacturing Process is Critical

    The road to take a drug compound from discovery to commercialization is long, expensive and often fraught with unforeseen challenges. While every project will undoubtedly face some bumps along its path, far too many programs hit insurmountable obstacles that require innovators to backtrack and correct their course before proceeding, further extending timelines and adding costs.

  • Single-Vendor CDMOs Bring Speed And Cost Savings To The Table

    A single vendor offers access to a network of experts across several disciplines who can share knowledge about a project as it moves from phase to phase, thus helping to navigate its path toward commercial success. Following a CPhI North America panel about single-source CDMOs, Paul Nelson, vice president of supply chain and R&D at Amring Pharmaceuticals, discusses his experience with single-source CDMOs.

  • How To Rapidly Create Single-Use Biomanufacturing Capacity

    To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.

  • Consultants’ Guide To Flexible Biomanufacturing Solutions

    Consultants play a critical role in ensuring the long-term success of small biopharmaceutical companies, though much of their work happens behind the scenes. From lifecycle planning to marketing advice, consultants help fill gaps in knowledge while having their fingers on the pulse of new production strategies that might be a fit for clients.

  • What Value Can An Integrated Solution Bring To Your Biopharma Outsourcing Strategy?

    The growth in outsourcing is one strategy life science innovators are pursuing to address the evolving pharma landscape; however, should a sponsor company seek the traditional route of utilizing multiple partners across the supply chain or does an integrated CDMO offer a more efficient and faster path to commercialization?

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CONTRACT PHARMA MANUFACTURING APPLICATIONS & STUDIES

  • Versatility Of Softgel Technology: The Encapsulation Of A Volatile Compound
    Versatility Of Softgel Technology: The Encapsulation Of A Volatile Compound

    A commercial stage medical technology company has developed SMART Softgels featuring a special shell to release quickly while still preventing evaporative loss during and after manufacturing. 

  • 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.

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.

High Potency API (HPAPI) Development & Manufacturing High Potency API (HPAPI) Development & Manufacturing

Piramal Pharma Solutions (PPS) is pleased to welcome Ash Stevens LLC as a part of the Piramal Group. Leveraging five decades of Ash Stevens’s operational experience and technical expertise, Piramal’s service offering now includes High Potency API (HPAPI) development and manufacturing capabilities. Located in Riverview, USA, our state-of the-art FDA licensed cGMP facility offers a full range of scale and containment options for high potency API manufacturing.

Contract Development And Manufacturing (CDMO) Formulation Services Contract Development And Manufacturing (CDMO) Formulation Services

Piramal Pharma Solutions is the contract development and manufacturing (CDMO) arm of Piramal Enterprises Ltd., having a vast network of development and manufacturing facilities located in North America, Europe and Asia.

API Development & Manufacturing Services API Development & Manufacturing Services

Piramal Pharma Solutions is the contract development and manufacturing (CDMO) arm of Piramal Enterprises Ltd. with a vast network of development and manufacturing facilities in North America,Europe and Asia.

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.

CDMO For All Phases Of The Drug Life Cycle CDMO For All Phases Of The Drug Life Cycle

Piramal Pharma Solutions is the contract development and manufacturing (CDMO) arm of Piramal Enterprises Ltd with a vast network of development and manufacturing facilities located in North America, Europe and Asia. 

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

Emergent BioSolutions typically performs the following testing on products.

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 PHARMACEUTICAL MANUFACTURING EVENTS

1st International Validation Week September 26 - 29, 2017
İSTANBUL
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner September 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Organizational Strategies for Reducing Human Error in GMP Environments October 3, 2017
1:00 - 2:30 PM EDT, Online training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!