Invest Into AccelPharma

Planned Services

In addition to “facility-related” commercial production regulator approvals in each target market, every new product must receive approval for commercial production (even if product has been successfully manufactured for years in another facility)

This is the case for all markets AccelPharma seeks to participate in, as China most recently aligned its policies with EU and US

Our new facility must undergo a rigorous and lengthy qualification process, showing consistency and meeting long list of production requirements

Filling Process
Vision
Establish leadership in commercialization of highly complex oncology / potent products to improve the lives and health outcomes of patients globally
Drivers
Large volume of expiring patents, significant drug shortages, substantial forecasted market growth, meaningful cost advantages
Focus
Highest quality standards in the world, precision manufacturing and cost efficiency via process excellence
Product Evaluation
Product Evaluation

AccelPharma has implemented and maintains a cost-effective manufacturing baseline (allowing competitive manufacturing pricing) through the following strategies:

  • leveraging our quality management system to drive cost effectiveness through continuous evaluation and improvement, ensuring product quality, process efficiency, operator effectiveness and a high level of equipment reliability and availability
  • undertaking all equipment preventative maintenance and repair to minimize reliance on outside vendors
  • implementing energy saving technologies in the facility design to reduce daily operating costs, including LED lighting systems, waste heat recovery systems, water recovery systems

Single Use Systems and Disposable Parts Drastically Transform Operation and Fit Our Strategy.

  • Breakthrough developments enable bioprocess manufacturing customers to fully recycle plastic single-use and disposable products
  • 95 percent of contact surfaces the products touch (tubing, disposable filter cartridges, connectors and clamps, etc.) will be single-use systems, including disposable plastic bags in smaller bioreactors.
Product Evaluation
female scientist looking at chemical reaction
Technical Transfer
Technical Transfer
  • Industry-standard practice which assures process quality and drug potency on the same or higher level in comparison to previously approved manufacturing facility
  • Full examination of transfer protocols (outlining steps and differences, if any), critical process parameters, performing equipment, backsides and comparisons according to "Scale Up and Post Approval Guidelines", all leading up to "Validation"
  • Assures consistency of raw materials and Active Pharmaceutical Ingredients (APIs)
Contract Filling
Contract Filling

Our focused approach allows for a seamless scale-up from clinical to commercial manufacturing, using the same manufacturing and quality management system baseline. Our contract manufacturing services include:

  • Toxicology batches
  • Phase I, II, and III clinical batches
  • Commercial batches

For customers constructing their own facilities who wish to minimize the time associated with facility commercialization, we also provide launch manufacturing services to allow simultaneous product development and commercial launch with facility implementation

microbiology working with petri dishes
Engineering and Technical
Engineering and Technical
Engineering and Technical

AccelPharma has a highly experienced engineering team responsible for the design, construction, commissioning, qualification, and maintenance of all facilities and equipment

Our engineering team integrates the client’s product process into the AccelPharma facility baseline and can assist clients with design and implementation of novel process systems and technologies

In addition to manufacturing services, AccelPharma offers the following engineering and technical services (for injectable vial, syringe, cartridge and ampule projects):

  • Facility design & implementation (facility / process capacity analysis, process technology options analysis, facility layout definition)
  • Process Design & Implementation (process equipment layout /specification, process equipment procurement, construction management)
  • Facility Qualification & Validation (equipment commissioning, equipment site acceptance testing, installation / operational qualification)

Supply Chain Implementation

Quality Management System Implementation

Cooperate with Us

Cooperate with Us

Please do not hesitate to contact us with any inquiries

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Head Office
AccelPharma, LLC
c/o 853 Camino Del Mar #201
Del Mar, CA 92014
Email: info@accelpharma.us
Manufacturing Facility
AccelPharma, LLC
Valdosta Opportunity Zone
Valdosta, GA
Email: info@accelpharma.us