Smart Manufacturing Helps Your Business

HELPING YOUR INDUSTRY

Why Anteco Pharma?

  • Facilities and process control systems.
  • Cost effective and time efficient.
  • A focus on you.
WHY ANTECO
Anteco Pharma is ISO 9001:2000 and ISO 13485:2003 Certified

FAQs


 

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 Anteco Pharma 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.

We can assure you that Anteco Pharma will provide the highest value lyophilization services in the industry.

What is an optimum lyophilization cycle?

There is no single answer to this question. Anteco Pharma 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. Anteco Pharma’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 information and intellectual property will be protected by Anteco Pharma?

Anteco Pharma’s only business is contract processing of its clients’ products. Therefore we are very sensitive to maintaining the confidentiality of your proprietary information and intellectual property. Typically, we sign a mutual confidentiality agreement (CDA) prior to any formal discussion about your product or process. Then we maintain all information – verbal or written – in strictest confidence throughout the life of the agreement – even if you choose not become our client. Customer specific documents are not subject to audit by other customers or third party auditors. We will also do everything possible to limit access by regulatory agencies and will be sure to notify you should such agencies request documents specific to your product.

Does Anteco Pharma fill, lyophilize and/or package sterile drug products?

Anteco Pharma does not currently fill or lyophilize sterile drug products.

Does Anteco Pharma 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. All of Anteco Pharma’s energy, skill and experience is directed toward making your product the best it can be, not in competing with you.

Explain how Anteco Pharma handles proposals, contracts and quality agreements.

As in every other part of our business, our approach to contracts is as flexible as necessary to meet each client’s requirements and practices. We can be as formal or as simple as you want so long as your specifications, standards and expectations are clear. Typically, we start with a confidentiality agreement (your format or ours) then proceed to a proposal that defines project scope, deliverables, schedules and cost. With client approval, this is the basis of a formal contract. We believe that a vital, part of the contract is a quality agreement. We find this is an effective way to convey your specifications and standards to Anteco Pharma; it provides a template for developing and implementing your process and quality procedures; and it assures that we are aware of your expectations.

What is Anteco Pharma’s policy regarding client visits and audits?

Anteco Pharma 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 Anteco Pharma’s equipment and facilities?

Anteco Pharma’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 Anteco Pharma’s operation.