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fill finish services

Meet Us

  • Outsourced Pharma West August 22— August 23, 2017Hyatt Regency La Jolla
    San Diego, California
  • The Bioprocessing SummitAugust 21— August 25, 2017Westin Copley Place - Boston, MA
    America Ballroom

Clinical Manufacturing

We manufacture products for our customers that support all phases of clinical trials. Contracting with us for clinical manufacturing has a number of advantages:

  1. Because clinical drug substances are frequently expensive and difficult to obtain in quantity, we have systems designed to minimize losses, ensuring customers get the maximum amount of finished product possible.
     
  2. We have a large selection of pre-qualified vials, stoppers, and syringes. Choosing one of these pre-qualified combinations can reduce project initiation to production time to two months in most cases.
     
  3. We can fill liquid or lyophilized products in vial sizes from 3 to 100cc and most major syringe sizes.
     
  4. We offer commercial-scale manufacturing and have a regulatory profile that includes approvals by regulatory agencies in multiple countries, allowing for growth and scale-up opportunities as your product progresses through to regulatory approval and commercial distribution.

Clinical Manufacturing

We manufacture products for our customers that support all phases of clinical trials. Contracting with us for clinical manufacturing has a number of advantages:

  1. Because clinical drug substances are frequently expensive and difficult to obtain in quantity, we have systems designed to minimize losses, ensuring customers get the maximum amount of finished product possible.
     
  2. We have a large selection of pre-qualified vials, stoppers, and syringes. Choosing one of these pre-qualified combinations can reduce project initiation to production time to two months in most cases.
     
  3. We can fill liquid or lyophilized products in vial sizes from 3 to 100cc and most major syringe sizes.
     
  4. We offer commercial-scale manufacturing and have a regulatory profile that includes approvals by regulatory agencies in multiple countries, allowing for growth and scale-up opportunities as your product progresses through to regulatory approval and commercial distribution.

Commercial Manufacturing

We currently fill over 20 commercial products for our customers with several more products pending approval. Using us for commercial manufacturing has a number of advantages:

  • We can fill liquid or lyophilized products in vial sizes from 3 to 100cc and most major syringe sizes.
     
  • We have two 240 ft2 lyophilizers capable of holding up to ~60,000 3cc vials. Lot sizes for larger vials are smaller and depend on vial diameter to determine maximum capacity.
     
  • We manufacture commercial products for worldwide distribution. Our Baltimore, MD (Camden Campus) facility has a regulatory profile that includes approvals in multiple countries, helping clients to expand their product filings internationally.
     
  • We can provide commercial packaging for finished drug products in our 3500 ft2 facility located in Baltimore, MD (Camden Campus).

Commercial Manufacturing

We currently fill over 20 commercial products for our customers with several more products pending approval. Using us for commercial manufacturing has a number of advantages:

  • We can fill liquid or lyophilized products in vial sizes from 3 to 100cc and most major syringe sizes.
     
  • We have two 240 ft2 lyophilizers capable of holding up to ~60,000 3cc vials. Lot sizes for larger vials are smaller and depend on vial diameter to determine maximum capacity.
     
  • We manufacture commercial products for worldwide distribution. Our Baltimore, MD (Camden Campus) facility has a regulatory profile that includes approvals in multiple countries, helping clients to expand their product filings internationally.
     
  • We can provide commercial packaging for finished drug products in our 3500 ft2 facility located in Baltimore, MD (Camden Campus).

Drug Product cGMP Lyophilization

Our two 240 ft2 lyophilizers can hold lot sizes of:

• 60,000, 3cc vials
• 50,000, 5cc vials
• 40,000, 10cc vials

Lot sizes for larger vials are smaller and depend on vial diameter to determine maximum capacity. We have lyophilized syringe products of up to 120 tubs (100 syringes per tub).

Products that require lyophilization are filled, partially stoppered, and loaded into the pre-chilled lyophilizer throughout the filling period. We have two filling machine options (low- or high- speed) to ensure that the time from formulation to lyo cycle start is appropriate and minimized where possible. The lyophilizer, with external condensers, has temperature control to as low as –65ºC and vacuum control between 50 and 1000 millitorr. A full load in the lyophilizer consists of 120 one-foot by two-foot trays. 

We can conduct turn-key lyophilization cycle development studies from design, implementation, and associated material characterization (i.e., FTIR, DSC and Freeze-Dry Microscopy). Elucidation and optimization of critical cycle parameters at the same CMO where clinical (and commercial) manufacturing will be conducted can significantly reduce timelines and maximize the probability of success for your lyophilized drug product.

Drug Product cGMP Lyophilization

Our two 240 ft2 lyophilizers can hold lot sizes of:

• 60,000, 3cc vials
• 50,000, 5cc vials
• 40,000, 10cc vials

Lot sizes for larger vials are smaller and depend on vial diameter to determine maximum capacity. We have lyophilized syringe products of up to 120 tubs (100 syringes per tub).

Products that require lyophilization are filled, partially stoppered, and loaded into the pre-chilled lyophilizer throughout the filling period. We have two filling machine options (low- or high- speed) to ensure that the time from formulation to lyo cycle start is appropriate and minimized where possible. The lyophilizer, with external condensers, has temperature control to as low as –65ºC and vacuum control between 50 and 1000 millitorr. A full load in the lyophilizer consists of 120 one-foot by two-foot trays. 

We can conduct turn-key lyophilization cycle development studies from design, implementation, and associated material characterization (i.e., FTIR, DSC and Freeze-Dry Microscopy). Elucidation and optimization of critical cycle parameters at the same CMO where clinical (and commercial) manufacturing will be conducted can significantly reduce timelines and maximize the probability of success for your lyophilized drug product.

Packaging

In 2016, our Baltimore, MD (Camden Campus) facility expanded their packaging footprint to over 3500 ft2, with new individual areas for staging, packaging, bulk packaging and inspections.

Our commercial packaging facility includes:

  • Fully automated cartoning and labeling equipment
  • Dedicated project staging areas with secured access
  • Upgraded HVAC RTUs for temperature/humidity control
  • 4ft dividing walls with pocket doors can separate room for product/activity segregation
  • Ability to bulk package and label products at the same time
  • 16 visual inspection stations

Packaging

In 2016, our Baltimore, MD (Camden Campus) facility expanded their packaging footprint to over 3500 ft2, with new individual areas for staging, packaging, bulk packaging and inspections.

Our commercial packaging facility includes:

  • Fully automated cartoning and labeling equipment
  • Dedicated project staging areas with secured access
  • Upgraded HVAC RTUs for temperature/humidity control
  • 4ft dividing walls with pocket doors can separate room for product/activity segregation
  • Ability to bulk package and label products at the same time
  • 16 visual inspection stations

Product Testing

We typically perform the following tests:

  • Startup: Identification testing on client supplied raw materials (API and excipients).
  • In-process testing sufficient to ensure bulk formulation is done correctly and other standard in process tests (pH, density, bioburden, etc. as appropriate).
  • Finished product testing as requested by the client, but we do sterility at a minimum.

Our Analytical Services Department (QC) can perform the following tests:

  • HPLC
  • TOC
  • IR
  • Karl Fischer
  • Dionex IC
  • Viscosity
  • Dissolved Oxygen
  • UV
  • RI
  • GC
  • TLC
  • SVP
  • Osmolality
  • Compendial Raw Material Testing

Our Microbiology Department can perform the following tests:

  • Enhancement & Inhibition
  • Bioburden Method Qualification
  • Bacteriostasis/Fungistasis
  • Final Product Sterility
  • Endotoxin
  • Bioburden
  • Bulk Sterility
  • Stability Testing

Stability Testing

We have validated chambers for ICH stability temperatures in place and operating. Upon request, we will generate stability testing protocols and schedules, which are rigorously followed. We will also quote individual tests requested by clients to support stability programs run by clients in their facilities.

Product Testing

We typically perform the following tests:

  • Startup: Identification testing on client supplied raw materials (API and excipients).
  • In-process testing sufficient to ensure bulk formulation is done correctly and other standard in process tests (pH, density, bioburden, etc. as appropriate).
  • Finished product testing as requested by the client, but we do sterility at a minimum.

Our Analytical Services Department (QC) can perform the following tests:

  • HPLC
  • TOC
  • IR
  • Karl Fischer
  • Dionex IC
  • Viscosity
  • Dissolved Oxygen
  • UV
  • RI
  • GC
  • TLC
  • SVP
  • Osmolality
  • Compendial Raw Material Testing

Our Microbiology Department can perform the following tests:

  • Enhancement & Inhibition
  • Bioburden Method Qualification
  • Bacteriostasis/Fungistasis
  • Final Product Sterility
  • Endotoxin
  • Bioburden
  • Bulk Sterility
  • Stability Testing

Stability Testing

We have validated chambers for ICH stability temperatures in place and operating. Upon request, we will generate stability testing protocols and schedules, which are rigorously followed. We will also quote individual tests requested by clients to support stability programs run by clients in their facilities.

Fill Finish Case Studies

Click below to read our case studies: