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CRB TECH TANK: Game Changers in Manufacturing Supply Chain

03/26/2015

Come listen to CRB subject matter experts discuss new disruptive technologies, and the impact they will have on current and future manufacturing supply chain strategies.  These game changers in bulk biologic production and drug delivery are altering the way we think about facility design and production planning.  

Additionally, get the latest information on the mandatory regulatory changes in serialization that will need to be implemented for manufacturers to ship their product within the next two years.

Impact of Delivery Systems on Manufacturing Strategies
A Look into Upcoming Aseptic Trends

With an ever-changing product pipeline and continued emphasis on user-friendly drug delivery methods, manufacturing strategies in the Biopharmaceutical industry are becoming more dynamic in order to increase equipment life expectancy for a diverse range of products. Delivery devices are being selected to accommodate several different products, in order to ensure the greatest return on investment for fill-line equipment purchased.

Advancements that allow smaller doses to deliver the same response are also shaping manufacturing strategies. With more effective dosing, bulk product production plants may not need as many expansions when making the switch to manufacturing different products. In fact, manufacturing facilities may reduce in size, as both delivery devices and fill lines will accommodate a range of products.  As effective dosing and easy-to-use drug delivery methods become more popular, it is still important to ensure patients will be compliant in taking their medication, given a dosage methodology that is more user-friendly.

As Clients consider patient care, drug dosage and delivery methods while developing their facilities, we have to be ready with the machines that can produce these advanced methodologies in a simplified manner that will meet quality requirements with consideration for what other forms/therapies for which they can be effectively used.

3 Brief Learning Objectives for the Session:

  1. Identify advancements in cutting-edge drug delivery methods and their effects on the patient.
  2. Understand the impact of user-friendly delivery methods on manufacturing strategies and facilities. 
  3. Address what these new delivery methods and manufacturing strategies advancements mean for the future of the BioPharma industry.

Speaker Names / Titles / Contacts:
Christa Myers, Associate / Lead Process Engineer – CRB
christa.myers@crbusa.com
Todd Vaughn, Associate / Lead Process Engineer – CRB
Todd.vaughn@crbusa.com

Next Generation Biomanufacturing - Leveraging the Benefits of Continuous Closed Processing

In response to the uncertainty of ever-changing product pipelines, the biotech industry has recently been evolving to develop flexible manufacturing solutions that can be quickly mobilized to provide a nimble response to changes in production demands.  The industry has concurrently improved its ability to assess and control the risk to the manufacturing process by engineering solutions to improve the closure of the process.  However, these flexible manufacturing solutions come with capacity limitations that can inhibit their applicability for certain larger scale applications. The advent of continuous processing technologies opens the door to coupling upstream and downstream unit operations to achieve a viable solution for end to end continuous manufacturing of bulk drug substances.  Compounding the benefits of other enabling technologies – continuous closed processing and implementation of single-use systems, where appropriate – results in a next generation biopharmaceutical manufacturing facility that significantly reduces the facility footprint, capital investment, manufacturing cost of goods, and improves utilization of assets when compared to conventional batch processing.

3 Brief Learning Objectives for the Session:

  1. Understand how the implementation of continuous closed processing impacts the design of  biopharmaceutical manufacturing facilities
  2. Analyze the impact to cost of goods for manufacturing therapeutic proteins using a continuous closed process relative to a conventional batch process
  3. Understand some of the risks and barriers to entry limiting the implementation of continuous closed processing technology

Speaker Names / Titles / Contacts:
Matthew Kennedy, Bioprocess Specialist – CRB
matt.kennedy2@crbusa.com
Steve Attig, Bioprocess Specialist – CRB
steve.attig@crbusa.com

Drug Supply Chain Security Act (DSCSA) – Enterprise Disruption

The US federal government passed the Drug Quality and Security Act (DQSA) in November 2013 with deadlines from 2015, 2017 and 2023.  The DSCSA 2017 deadline to domestically ship your Rx products with a unique serial identification number and requirement for all supply chain partners to have electronic connectivity between trading partners is now less than three (3) years away.  The lot traceability portion of the law has already begun and other worldwide regulations are also already in effect or about to become law (China, Turkey and Brazil).  Taking into account contingency time, this leaves companies little time to implement an enterprise wide serialization system that will impact nearly every group within their organization.  The disruption to existing manufacturing and distribution processes will be significant.  The keys to a smooth implementation will be to understand the requirements both domestically and internationally, and plan for the flexibility to address changes in regulatory interpretation and operational procedures as they occur.  It is way too late for the “wait and see” strategy.  Only planning and implementing a strategy now will prevent the potential of a supply chain interruption in your products availability to the market when the deadline hits.

We will discuss the ripple effect this law will have on the manufacturer’s operating processes, existing ERP and WMS systems as well as transmission protocols and transaction reporting requirements for trading partners (Manufacturers, CMO’s 3PL’s Distributors and Wholesalers), all the way down to the Pharmacy retailer.   DSCSA will cause major changes in your operations for those who are unprepared.  Current enterprise systems don’t have the capabilities necessary to comply with all of these requirements and may be costly and inefficient to modify.  Just creating the requirements specification for modifying the enterprise system could take many months, and engineering and IT resources are often scarce and unprepared to handle this requirement.  We will discuss the use of Cloud based Serialization Track and Trace Systems to comply with this law as a cost effective, and efficient method for management of serial number allocation to packaging lines and compliance with DSCSA law. 

3 Brief Learning Objectives for the Session:

  1. Recognition of the impact serialization will make on the entire enterprise
  2. Lessons learned from a serialization implementation
  3. Implementation Plan and Resources to meet 2017 DSCSA deadline

Speaker Names / Titles / Contacts:
Steve Peterson – Project Manager, PMP – CRB
steve.peterson@crbusa.com
Darryl Peterson – Senior Sales Director, rfXcel
dpeterson@rfxcel.com

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