Highly Potent Drugs

Ajinomoto Althea, a biopharmaceutical CDMO, is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates (ADCs), the company announced on Oct. 14, 2015. The new facility is located in close proximity to the company’s existing operations in San Diego, CA.

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

Engineered containment performance testing is a more robust method for validating containment systems than worker-exposure measurement methods.

Designed with safety standards in mind, flowtherm Ex incorporates a number of connectable sensors, such as vane wheel, vortex, thermal, Pt100, and other physical sensor with analog output, thereby allowing a range of applications.

PSL has developed a dispensary isolator with a contained drum hoist mechanism for highly potent API production.

Penn Pharma's equipment addition meets growing need for continuous dry granulation and for handling of highly potent drugs.

It is vital that companies involved in the manufacturing and handling of cytotoxic drugs ensure that staff are given the highest possible levels of protection.

Enclosures contain powders and particulates during hazardous drug manipulation.

Catalent will add potent containment for blending and granulation at its New Jersey manufacturing Center of Excellence.

A draft NIOSH Current Intelligence Bulletin on recommendations for reducing worker exposure to reproductive risks of drugs is available for public comment.

Catalent Pharma Solutions announces additional packaging and storage space for highly potent and cytotocix drugs at Kansas City facility.

Manufacturers using highly potent APIs must examine cross-contamination routes and determine acceptable limits.

LABOCHIM SpA completes construction on multipurpose high-potent API plant in Milan.

Advances in solid and liquid formulation techniques are providing more options.

New manufacturing capacity at the Le Mans, France facility is being used to scale up antibody drug conjugates.

Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.

Novozymes Biopharma has released new study data on extending the serum half-life of albumin in vivo.

Roger Hayes of MPI Research discusses highly potent drug development.

The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.

A new study reveals how a promising anticancer specifically kills prostate cancer cells by compromising their ability to withstand environmental stress.

Molecular Profiles has opened a new facility in the UK following official approval from MHRA.

Risk management guides decisions in facility design and operation for highly potent drugs.

A conversation with Kevin Brady of Alkermes about how high potency APIs are changing the way drugs are developed and manufactured in terms of process, equipment and regulations, including a case study that demonstrates the effective scale up or manufacture of a drug with a highly potent API.

The lipid-based method provides a tool for delivery of highly potent, poorly soluble, and unstable APIs. And new in-process capsule printing and shell technologies expand softgels’ applications further.

The South Wales, UK contained-manufacturing operation was built in less than a year using design-to-manufacture and modular approaches.

Results of an American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable survey found that there is real interest in continuous processing and the use of flow chemistry, but hurdles remain.

PIERRE FABRE MEDICAMENT PRODUCTION has 22 years experience in isolator technology for aseptic filling of high potent freeze-dried injectable products.

Custom manufacturers with expertise in highly potent API production discuss the latest issues and technology developments in the field.

Potency is a required measurement to determine the amount of active ingredient contained in a preclinical dose formulation. Assessing potency ensures that the test system receives the appropriate amount of active ingredient based on predetermined specifications.

Pfizer has two manufacturing facilities in Germany for high-potency manufacturing, respectively in Freiburg and Illertissen. Pharmaceutical Technology's Executive Editor Patricia Van Arnum visited the facilities and spoke to the company about the design and operation of these facilities.