Lyophilization Contracting

We collaborate with small manufacturers and large international operations to deliver the best lyophilization solution for product excellence.
AMS specialize in contract manufacturing of lyophilization and related processing of pharmaceutical intermediates, medical devices, specialty food and nutritional ingredients. We offer industry-leading facilities and cost-effective solutions for a wide variety of manufacturing and product development challenges.

Our lyophilization experts include engineers, scientists, skilled technicians and mechanics supported by a world-class quality organization. Because each project is unique, we draw on their expertise and experience as well as our wide range of services to develop and operate an optimum process for your product.

Our cGMP compliant facilities provide the flexibility to handle an ever-expanding assortment of processing challenges that involve formulation, lyophilization, packaging, process development / scale-up, and quality / regulatory consulting. We offer multiple, fully validated lyophilizers with capacities from 1 to 2,000 liters, and ISO 7 (class 10,000) clean suites.

 

  • State-of-the- Art Facilities And Process Control Systems.
  • Years Of Lyophilization Experience in R&D, Engineering, Manufacturing, Project Management, Quality, Compliance and Customer Service.
  • Cost-Effective & Time Efficient To Protect Your Costs.
  • Flexible And Adaptable to meet your needs.
 

 

Capabilities

Our staff are experienced in every facet of the lyophilization and formulation process. From the design of the process to the daily maintenance of the equipment, our capabilities meet the needs of the pharmaceutical, biotechnology, Medical Device and Nutritional Ingredient industries experience, and include:

 

  • Technical and Business Management.
  • Facility and equipment engineering, design and project management.
  • GMP compliant manufacturing processes and regulatory requirements.
  • Product and process compliance
  • FDA submissions
      • New drug and device applications
      • FDA inspection liaison
  • Quality systems
      • Analytical methods
      • Inspection
      • Environmental control
      • Validation consulting and implementation
      • Microbiological / environmental testing and consulting
  • Fermentation
  • Tablet and capsule manufacture
  • Lyophilization equipment and design
  • Milling, blending and granulating
  • Protein purification
  • Automated filling/packaging
  • Storage, shipping and distribution services.
  • First Class Customer Service

 


 

Equipment and Facilities

Our cGMP compliant equipment and facilities can be utilized for the most demanding lyophilization, formulation and packaging processes. Our capacities are unmatched, our equipment the best in the business.

 

Lyophilizers

  • Capacities from 1 - 2,000 liters 
  • Stainless steel construction
  • Internal stoppering
  • Capacity to backfill with Argon or Nitrogen
  • Sterilize in place (SIP)

 

Control and monitoring instrumentation.

  • Fully-validated

Self-contained clean suites

  • ISO 7 (Class 10,000)
  • Dedicated HVAC with temperature and humidity control.
  • Non-reactive, cleanable surfaces.
  • Dedicated gowning / de-gowning areas.

 

Packaging and labeling

  • Customized to meet the unique, industry-specific configurations of your product.
  • Medical device packaging and labeling.
  • Multiple configurations of bulk packaging for food and pharmaceutical ingredients.
  • Milligram to ton capacities.
  • Dedicated and custom-designed packaging operations.

 

Formulation

  • Multiple sizes and configurations of tank sizes and sanitary pumps.
  • Agitation and temperature controls.
  • USP purified water system.
  • Controlled chemical storage and dispensing.

 

Shipping and handling

  • cGMP compliant facilities for shipping and receiving grams to tons.

 

Complete documentation and traceability

  • For all materials and products from purchase order through shipping with proximity to major transportation hubs and interstate highways.

 

Other services

  • Equipment for unique processes, with the flexibility to expand if necessary.
  • Vial filling, lyophilization and stoppering. (medical device and non-cGMP).
  • Temperature and humidity-controlled storage (ambient to -40C).

 

Compliance and Quality System

Every project is carefully assessed for budget, timelines, and overall business objectives. We align your expectations with the highest quality standards, including technical excellence, innovation and service. Our quality system carries  internationally recognized ISO 13485 2016 certifications.

ATTWILL meets the regulatory standards in each of the sectors we operate. Our Compliance and Quality staff constantly monitor the requirements and refine our facilities and systems to ensure we are compliant to all new developments. Our compliance and regulatory standards include:

 

  • US FDA Drug registration
  • US FDA Medical Device registration
  • Kosher Certification
  • Food manufacturing license
  • ISO 13485 2016 (medical device) certification
  • 21 CFR Parts 210 and 211 (drug cGMP)
  • 21 CFR Part 820 (medical device cGMP)
  • 21 CFR Part 111 (nutritional supplement cGMP)

 


 

What is lyophilization?
Lyophilization is a stabilizing process in which a substance is first frozen and then the quantity of the solvent (generally water) is reduced, first by sublimation (referred to as the primary drying process) and then desorption (known as the secondary drying process) to values that will no longer support biological activity or chemical reactions (INSITE Vol 1 Number 9, November 1998). Lyophilization can also be described as a method of drying substances such as proteins, microorganisms or pharmaceutical preparations without destroying their physical structure. This is achieved by freezing a material to a temperature below its eutectic or glass transition point, creating a deep vacuum, adding the latent heat of sublimation then re-freezing the resulting vapor on a condenser. Precise control of heat input permits drying from a frozen state without product melt-back.
What is the difference between lyophilization and freeze drying?
There is no difference. The term "lyophilization" is commonly used in the pharmaceutical and medical device industries while food processors generally refer to "freeze drying".
What will it cost to dry my product?
This is commonly one of the first questions asked by a prospective client. It is also a question that ATTWILL Medical Solutions generally defers until we know more about your product. Our costs are dependent on a large number of factors, including: • Amount of process development • Nature of your material • Extent and nature of pre and post lyophilization processing • Quantity of material (batch size) • Frequency of lyophilization needs • Duration of lyophilization cycle, etc. Rest assured that Attwill Medical Solutions will provide the highest value lyophilization services in the industry.
What is an optimum lyophilization cycle?
ATTWILL Medical Solutions considers each product and process to be unique and utilizes its expertise (and, if necessary, the expertise of its analytical partners) to develop a cycle that yields a product meeting or exceeding the client's specifications. Whether we start from scratch or adapt your existing process to our equipment, we will do everything necessary to meet your product standards.
How can I evaluate the quality of a lyophilized product?
Only you can define your product's specifications and quality expectations. ATTWILL Medical Solutions's lyophilization processes will achieve the least damage possible to your most delicate materials. We are capable of measuring and controlling moisture by a variety of methods (LOD, AW, Karl Fischer, etc) as well as performing or contracting other critical analytical procedures. The final, and most important, question is, "does your product have the specified activity and stability at your pre-defined storage conditions"? With our staff's long experience in all phases of the nutritional, pharmaceutical and medical device industries we can help you answer that question.
How can I prevent damage to my product during the lyophilization process?
Most protein based materials are subject to damage during freezing, primary and/or secondary drying. This damage can be minimized through the use of additives and cryoprotectants. Our experienced staff can help you to determine the best additives for your process. Just as important are a freezing rate and a drying cycle specifically optimized for your product. Let us develop a process or adapt your process to achieve the best possible result for your product.
How can I be assured that proprietary and intellectual property will be protected by ATTWILL Medical Solutions?
ATTWILL Medical Solutions's equipment and facilities are designed and operated to assure that they are as reliable as modern technology allows. Comprehensive interior and perimeter security systems not only protect from intrusion and fire, they also permit us to monitor, document, and alarm critical equipment operations and environmental conditions both locally and from remote locations. Additionally, most of our processing equipment and all of our lyophilizers have redundant mechanical and control systems that allow machines to continue operation even if components were to fail. Finally, our cGMP compliant preventive maintenance programs assures that equipment is always in top shape and is as dependable as every other part of ATTWILL Medical Solutions operation.
Does ATTWILL Medical Solutions fill, lyophilize and/or package sterile drug products?
NO we do not currently fill or lyophilize sterile drug products.
Does ATTWILL Medical Solutions manufacture its own line of nutritional, drug, or medical device products?
Our only business is contract processing. Unlike many of our competitors, this business is not a sideline, fill-in or supplement to our own products. Rest assured that ATTWILL Medical Solutions will not be competing with you.
Explain how ATTWILL Medical Solutions handles proposals, contracts and quality agreements.
Our only business is contract processing. All of ATTWILL Medical Solutions energy, skill and experience is directed toward making your product the best it can be, not in competing with you.
What is ATTWILL Medical Solutions's policy regarding client visits and audits?
ATTWILL Medical Solutions encourages client visits, including formal audits, observation of processing or periodic project reviews. Our only limitation is when another client's proprietary information could be compromised. This welcome applies to both customer personnel and third-party auditors.
How reliable are ATTWILL Medical Solutions equipment and facilities?
ATTWILL Medical Solutions's equipment and facilities are designed and operated to assure that they are as reliable as modern technology allows. Comprehensive interior and perimeter security systems not only protect from intrusion and fire, they also permit us to monitor, document, and alarm critical equipment operations and environmental conditions both locally and from remote locations. Additionally, most of our processing equipment and all of our lyophilizers have redundant mechanical and control systems that allow machines to continue operation even if components were to fail. Finally, our cGMP compliant preventive maintenance programs assures that equipment is always in top shape and is as dependable as every other part of ATTWILL Medical Solutions operation.