Archives by Day: September 14, 2021

sterile injectables

Oakwood Labs has remained a reliable provider of pharmaceutical contract manufacturing services for more than twenty-five years. As a specialty pharmaceutical company, we are focused on two main areas. The first is our CDMO business which is concerned with the development and manufacture of sustained-release injectable pharmaceuticals through the use of our microsphere-based drug delivery technology. The second is our CMO business which focuses on manufacturing sterile injectable products for clinical, registration, and commercial needs.

Our team supports the manufacturing of sterile injectables to provide enhanced therapeutic benefits to patients in addition to excellent returns to our pharmaceutical partners. Sterile injectables continue to grow within the pharmaceutical industry and are expected to be produced to standards of safety, purity, and quality. Learn more about sterile injectable development at Oakwood Labs below.

Features of Oakwood’s Facility for Manufacturing Sterile Injectables

A full service CMO is valuable within the pharmaceutical industry due to its ability to provide aseptic pharmaceutical manufacturing and fill-finish capabilities. Sterile injectable products are an essential part of the global healthcare system. They are used to treat a wide range of conditions, from life-threatening diseases such as cancer or HIV/AIDS to chronic conditions such as diabetes and multiple sclerosis, and many others.

Also, aseptic manufacturing is essential because it minimizes the risk of introducing bacteria and contaminants that can enter the body when administering the medication.

In order to enhance our partnering and sterile injectable development capabilities, Oakwood Labs maintains an aseptic, FDA-approved manufacturing facility, ideal for manufacturing sterile injectables. This facility is equipped with the following beneficial features:

  • Non-aseptic formulation
  • Vial capping
  • Compact and portable equipment train
  • Aseptic filling
  • Aseptic formulation
  • Inspecting, labeling, and packaging
  • Raw material dispensing and weighing
  • Shipping, receiving, and warehouse space
  • In-house QC microbiology and QC chemistry
  • Equipment prep and staging
  • Aseptic lyophilization

Our pristine full-service facility is just one of the many reasons that Oakwood Labs is an effective CMO partner. Since 1997, we have been achieving milestones within set deadlines, providing transparent communication, adapting to change, and offering our expertise throughout the process.

Choose Oakwood Labs for Your Sterile Injectable Needs

Oakwood Labs has been an effective partner to a great deal of pharmaceutical firms of various sizes across the globe. When you choose to partner with our GMP manufacturing facility, you are guaranteed to receive short lead times, robust quality systems, and CMC development capabilities for a broad range of sterile injectables and assorted products.

Oakwood Labs is fiercely committed to quality and has had a long history of compliance. Our Quality System ensures that sterile injectables manufactured at our facility comply with specified requirements and are safe, pure, and effective throughout the entirety of the product lifecycle.

When it comes to manufacturing sterile injectables, there is no better choice than Oakwood Labs. Choose us to be your reliable and dedicated partner.

Oakwood Labs Offers Pharmaceutical Contract Manufacturing Capabilities and Other Services

At Oakwood Labs, we support all phases of long-acting injectable (LAI) development. We pride ourselves on being a full-service cGMP manufacturing facility capable of providing services to our partners. The range of manufacturing services we offer includes:

  • Small-volume sterile injectables
  • Sterile liquids, sterile lyophilized parenteral, suspensions, microspheres, and more
  • Class III and IV controlled substances
  • Vials with lyophilized or plug stoppers (13mm and 20mm openings)
  • Phase I, Phase II, or Phase III clinical trial material
  • Commercial product to be utilized in humans or for veterinary use

In addition to the variety of GMP pharmaceutical manufacturing capabilities, Oakwood Labs also supplies other services including the following:

  • Formulation and analytical development activities
  • Accelerated and long-term stability studies
  • Scale-up, validation, or engineering batches
  • Complete method transfer and validation
  • Batch record and protocol development

Not sure which of our services is best suited for your industry needs? Reach out to our team of experts today!

Our GMP Aseptic Manufacturing Capabilities

Sterile injections are made possible with procedural measures that prevent contamination, like Good Manufacturing Practices and an aseptic facility. An FDA-approved cGMP aseptic facility for sterile injectables has the ability to support clinical, registration, and commercial batches. We also host short- and long-term stability studies, which help you to achieve the perfect formulation.

Our in-house experience and expertise include method development, qualification, and validation support, as well as robust quality systems. Our team also has aseptic fill and finish capabilities, which means that we can create aqueous, solvent-based suspensions, as well as liquid and lyophilized presentations. The fill volume range is between 1 mL and 30 mL and the vial size range is between 2 cc and 30 cc.

These capabilities allow us to provide value to each partner we work with. If you are looking for a team that will deliver fast turnaround times, expertise in complex processes, assistance in technology transfer, and a high level of FDA quality standards, Oakwood Labs is your destination.

What are the current Good Manufacturing Process standards set by the FDA?

cGMP standards state that a pharmaceutical manufacturer must:

  • Have a separate, classified, and clean area for production
  • Filter and properly circulate air
  • Maintain and sterilize all containers and closures
  • Train and monitor all personnel involved with the process
  • Wear sterile clothes
  • Set time limits for different steps of the process
  • Simulate and record the manufacturing process

Answering Your Frequently Asked Questions About Sterile Injectables

What technology is used during manufacturing to create sterile injectables?

Sterile processing equipment is necessary for pharmaceutical production and is essential for satisfying regulatory requirements. Therefore, it is common to see autoclaves, electro-steam generators, and washer-disinfectors in the pharmaceutical manufacturing process.

What are the common routes of administration for sterile injections?

There are four common methods of administration:

  • Intravenous
  • Intramuscular
  • Subcutaneous
  • Intradermal

Since injectables bypass the natural barriers of the body, it is essential for them to be sterile to reduce the risk of injections or complications in patients.

What is involved when testing sterile injectables for sterility?

According to the WHO, a pharmaceutical container is defined as sterile when the probability that it is contaminated with replicating microorganisms is less than one out of one million.

Sterility testing often involves the following:

  • Biological indicators – Using microorganisms to test for the effectiveness of the sterilization
  • Sterility tests – Culturing samples to check for microbial growth
  • Endotoxin testing – Ensuring the product is free from pyrogens that cause fever

Since not every container can be opened, random samples are taken and tested to represent an entire batch.

How do sterile injectable drugs get packaged?

Depending on the needs of the patients and facility, sterile injectables can be put into:

  • Ampoules – Sealed glass containers that are used once
  • Vials – Glass or plastic containers that can be used once or for multiple doses
  • Prefilled syringes – Packaged in ready-to-use doses that reduce preparation time and contamination risk
  • Cartridges – Units commonly used for insulin

Contact Oakwood Labs to Learn More About Our Sterile Injectable Development

Are you looking for sterile injectables from a reliable company with decades of experience? Oakwood Labs has the solutions for you. Our team will work closely with you through proof of concept, feasibility studies, clinical trial material, and, ultimately, FDA-approved commercial supply.

Questions on our sterile injectable development? Contact Oakwood Labs today to learn more about how we can help. We look forward to assisting you!